International Journal of Clinical Trials

Bacterial DNA in joint tissue and its role in osteoarthritis: a narrative review

2026-10-27T07:02:03+0530

Osteoarthritis (OA) is a complex condition that involves immunological, metabolic, and inflammatory processes, as well as mechanical deterioration. Even in the absence of overt infection, recent developments in molecular diagnostics have revealed that synovial fluid, synovial tissue, and articular cartilage from patients with OA contain bacterial DNA and other microbial components. These results cast doubt on the conventional theory of joint sterility and raise the possibility that the gut–joint axis plays a role in disease etiology. In accordance with the PRISMA-style methodology, this narrative review summarizes the most recent human data on microbial DNA detection in joint tissues, investigates mechanisms of innate immune activation and microbial translocation, and assesses their clinical implications. Microbial markers in OA joints differ from those in healthy controls. They are associated with inflammatory mediators such as lipopolysaccharide (LPS), according to observational, cross-sectional, and emerging interventional studies. Toll-like receptor (TLR)-mediated pathways may be activated by microbial components, leading to cartilage degradation and synovitis. Causality remains unknown despite encouraging results due to methodological flaws and potential contamination biases. Gaining insight into the role of microbes in OA could lead to the development of new biomarkers and treatments targeting the microbiome.

The role of artificial intelligence in clinical trials: opportunities

2026-10-27T07:02:00+0530

Artificial intelligence (AI) is now embedded across the clinical trial lifecycle, from target discovery and protocol design to recruitment, conduct, and post-marketing surveillance. Adoption has outpaced validation, and the randomised controlled trial (RCT) evidence base remains geographically uneven. For India, the question is no longer whether to adopt AI in trials, but how to do so without importing algorithms never validated on Indian patients. Narrative review of peer-reviewed literature (2018–2026) indexed in PubMed and major journal families, supplemented by official Indian regulatory documents (CDSCO, ICMR, MeitY). The review maps AI applications across the trial lifecycle, examines RCT evidence, and situates findings in India's regulatory context. A 2024 scoping review identified 86 AI RCTs (2018-2023); 81 per cent reported a positive primary endpoint, although 63 per cent were single-centre and only 19 per cent of post-2021 trials cited CONSORT-AI.¹ Machine learning predicts early trial termination with area under the curve 0.80.² The first generative-AI-discovered small molecule, rentosertib for idiopathic pulmonary fibrosis, completed phase 2a in 2025.³ Counter-examples persist: the Epic Sepsis Model showed sensitivity of 33 per cent on external validation.⁴ India's sepsis mortality (36.3 per cent overall; 50.8 per cent in septic shock) and projected antimicrobial-resistance deaths (11.8 million in South Asia by 2050) make trial-grade AI validation a national imperative. AI will reshape clinical trials, but only prospective, externally validated, reporting-standard-compliant studies, increasingly in Indian populations, will turn potential into evidence that regulators and clinicians can act on.

The evolving architecture of India’s clinical-trial rules, 2019-2026: a chronological appraisal and stakeholder analysis of the New Drugs and Clinical Trials Rules and their amendments

2026-10-27T07:01:58+0530

India replaced the decades-old Schedule Y regime with the New Drugs and Clinical Trials (NDCT) Rules, 2019, promising a framework that would both speed up clinical research and protect the people who take part in it. Most published accounts examine one stakeholder at a time, most often the ethics committee, and treat the Rules as a static document, even though the framework has kept changing. This paper does two things at once. First, it reads the architecture of Indian clinical-trial regulation and its amendments as a single, continuous evolution: statutory timelines and deemed approval (2019), consolidation of the as-amended text (2022), a draft and then enacted registration regime for clinical research organisations (CROs) (2023-2024), digital onboarding through the SUGAM portal and a draft Indian Good Clinical Practice text aligning toward ICH E6(R3) (2025), and a 2026 cluster easing test-licence, bioavailability/bioequivalence and ethics-committee requirements, of which two amendments are now in force and two remain in draft. A consistent direction emerges toward predictability, speed and formalisation. Second, it asks whose interests that trajectory has served, reading the text alongside India-specific implementation evidence across sponsors, CROs, investigators and sites, ethics committees, participants, and the regulator. We argue that facilitation has outpaced protection. The compensation formula has lost about a third of its real value since 2013, and ethics committees carry expanded duties without commensurate capacity. We close with three concrete recommendations: revisit the compensation formula, mandate results disclosure, and resource ethics-committee oversight.

Negligence without a patient: medical negligence in clinical trials in India and the comparative study of South Korea and Australia

2026-10-27T07:01:49+0530

Clinical research has migrated toward low- and middle-income countries, and India became a leading host before consent failures and participant deaths triggered a regulatory reckoning in 2013. The injured trial participant occupies an awkward position in medical negligence law: the intervention is experimental, its risks are by design incompletely known, and no settled standard of care governs the researcher's conduct. This study compares three jurisdictions. India, a common-law system, has adopted statutory no-fault compensation; South Korea, a civil-law system, relies on regulatory approval and indemnity insurance; Australia, a common-law system, is shaped by a landmark judicial standard and subsequent civil-liability reform. India's obligation requires sponsors to compensate trial-related injury without proof of fault, reaching injuries only associatively connected with a trial, making its principle the most protective in form. South Korea channels protection through institutional review boards and indemnity insurance, leaving the standard of care to malpractice litigation. Australia combines notification-based approval with a court-determined standard derived from Rogers v Whitaker, tempered by the customary-practice defence and supplemented by health complaints commissions. No jurisdiction performs well on compensation certainty, standard-of-care clarity and access to justice at once. The comparison supports three reforms for India: a defined standard of care, an independent compensation authority, and a clarified relationship between the no-fault remedy and the civil claim.

Comparative evaluation of dimensional changes achieved and osteopontin level in peri-implant crevicular fluid after sinus crestal floor elevation using piezosurgery and concentrated growth factor with or without allograft: a randomized clinical trial

2026-08-06T10:44:25+0530

Background: Limited residual bone height in the posterior maxilla often necessitates sinus floor elevation before implant placement. Piezosurgery-assisted crestal sinus floor elevation offers a minimally invasive approach with reduced membrane-related complications. Concentrated growth factor (CGF) has been proposed to enhance bone regeneration; however, the additional benefit of combining CGF with allograft remains unclear. This randomized clinical trial compared radiographic, clinical, and biochemical outcomes following crestal sinus floor elevation using CGF with or without demineralized freeze-dried bone allograft (DFDBA).

Methods: Twenty posterior maxillary implant sites requiring indirect sinus floor elevation were randomly allocated into two groups (n=10 each): group A, piezosurgery-assisted crestal sinus elevation with CGF + DFDBA; and group B, CGF alone. Simultaneous implant placement was performed in all sites. Vertical bone height (VBH) and bucco-palatal width (BPW) were assessed using cone-beam computed tomography at baseline and 6 months. Implant stability quotient (ISQ) was measured at baseline and 3 months. Osteopontin (OPN) levels in peri-implant crevicular fluid were evaluated at 15, 45, and 90 days using enzyme-linked immunosorbent assay.

Results: Both groups demonstrated significant increases in vertical bone height and implant stability over time (p<0.05). Group A showed significantly greater vertical bone gain at 6 months compared with group B (p<0.05). Bucco-palatal width remained relatively stable in both groups, although a significant reduction was observed in group B. OPN levels increased progressively in both groups during healing and were significantly higher in group A at all-time intervals (p<0.05).

Conclusions: Piezosurgery-assisted crestal sinus floor elevation using CGF, with or without allograft, resulted in favorable clinical and radiographic outcomes. The addition of DFDBA to CGF yielded greater vertical bone gain and higher OPN levels, suggesting enhanced regenerative activity during early healing.

Evaluating the effect of cryotherapy on injection pain and onset of action of precooled and warmed local anesthetic agent in symptomatic irreversible pulpitis patients: an in vivo study

2026-09-05T10:56:11+0530

Background: Pain is one of the main reasons for patients seeking dental treatment, but fear of pain attributed to injection is cited as an obstacle in providing appropriate dental care. Achieving profound pulpal anesthesia is challenging due to several factors but it is mandatory for successful completion of root canal treatment. To enhance the success rate of inferior alveolar nerve block (IANB) in mandibular teeth with SIP several approaches have been considered. Cryotherapy approach has been routinely employed in clinical settings. Therefore, the study aims to assess the pain at site, onset of action of temperature-controlled anesthetics with intraoral cryotherapy in patients with symptomatic irreversible pulpitis.

Methods: In this double‑blind, randomized clinical trial, 45 patients with deep carious lesions having moderate‑to‑severe pain in the mandibular first molar teeth were selected. Subjects were allocated randomly into various groups based on precooling agent and temperature of local anesthesia (LA): Group I-Normal LA with Lignocaine spray-control group, Group II: Prewarmed LA with Endo ice, Group III: Prewarmed LA with Ice cubes, Group IV: Precooled LA with Endo ice, Group V: Precooled LA with Ice cubes. All participants underwent an IANB, after which the pain at the site and onset of action were compared and evaluated.

Results: Statistical assessment of the data revealed a marked decrease in pain at the site with faster onset of action in Group V.

Conclusions: Cryotherapy application boosted the efficacy of IANB in anesthetizing mandibular molars with SIP.

Comparative evaluation of perioperative multimodal analgesia and single-bolus epidural analgesia in lower abdominal surgery: a randomized controlled study

2026-10-27T07:02:02+0530

Background: Effective postoperative pain management is essential for enhanced recovery after lower abdominal surgeries. While epidural analgesia has been widely used, multimodal analgesia offers a less invasive, opioid-sparing alternative. This study aimed to compare perioperative multimodal analgesia using pregabalin, nefopam, and paracetamol with epidural analgesia in terms of analgesic efficacy and recovery outcomes.

Methods: This prospective, randomized, single-blind study included 70 female patients (ASA I-II) undergoing lower abdominal surgeries under general anesthesia. Patients were allocated into two groups: Group A (multimodal analgesia) and group B (epidural analgesia). Postoperative pain (VAS score), hemodynamic parameters, time to first rescue analgesia, total rescue analgesic requirement, adverse effects, and time to ambulation were recorded over 24 hours. Statistical analysis was performed using independent t test and Fisher’s exact test.

Results: Baseline characteristics were comparable between groups. The multimodal group demonstrated significantly lower early postoperative pain scores and prolonged time to first rescue analgesia (147±94 vs 107±72 minutes, p=0.049). Fewer patients required ≥3 rescue doses (17.1% vs 40.0%). Hemodynamic parameters were largely comparable, although episodic elevations were observed in the epidural group. Time to ambulation was significantly shorter in the multimodal group (34.83±5.10 vs 37.94±5.25 hours, p=0.014). Adverse effects such as nausea, headache, and shivering were more frequent in the epidural group, though not statistically significant.

Conclusions: Perioperative multimodal analgesia provides effective pain control, reduces analgesic requirements, and facilitates earlier ambulation compared to epidural analgesia. It represents a safe, practical, and effective alternative for postoperative pain management in lower abdominal surgeries.

Comparative evaluation of caries removal using smart bur and ceramic bur in pediatric patients: an in vivo study

2026-10-27T07:03:07+0530

Background: Minimally invasive caries removal is a key principle in pediatric dentistry that preserves healthy tooth structure, maintains pulp vitality, and enhances patient comfort. Smart burs (polymer burs) and ceramic burs are conservative excavation systems designed for selective removal of infected dentin. This study compared the efficiency, efficacy, and patient comfort associated with these two minimally invasive caries removal techniques in children.

Methods: An in vivo randomized split-mouth clinical trial was conducted among 26 healthy children aged 6-12 years. Two carious primary mandibular molars in each participant were randomly assigned to smart bur and ceramic bur groups. Following topical anesthesia and rubber dam isolation, caries excavation was performed using the allocated bur. Efficiency was assessed by excavation time, efficacy by visual, tactile, and caries-detecting dye assessments, and patient discomfort using the face, legs, activity, cry, and consolability (FLACC) scale.

Results: Ceramic burs demonstrated significantly greater efficiency (2.72±0.26 versus 3.54±0.53 min; p<0.0001) and superior caries removal efficacy (0.88±0.33 versus 1.92±0.27; p<0.0001). Smart burs caused no significant increase in FLACC scores (p=0.5), whereas ceramic burs significantly increased patient discomfort (p<0.0001).

Conclusions: Both systems were effective for minimally invasive caries removal. Ceramic burs provided superior efficiency and efficacy, while smart burs offered greater patient comfort, making them a valuable option for pediatric minimally invasive caries management.

Effect of fluoridated alcoholic and non-alcoholic mouth rinses on the load-deflection rate of orthodontic archwires: an in vitro study

2026-10-27T07:03:06+0530

Background: Fluoride mouthrinses are routinely prescribed during orthodontic treatment; however, their interaction with different archwire materials may influence mechanical performance, particularly load-deflection characteristics. The aim of the study was to evaluate the effect of fluoridated alcoholic and non-alcoholic mouthrinses on the load-deflection properties of various orthodontic archwires.

Methods: This experiment was conducted in vitro and involved 75 orthodontic archwire samples of 0.016-inch thickness, consisting of stainless steel, Ni-Ti, Cu-NiTi, β-Ti, and aesthetic-coated wires. The samples were categorized based on the type of liquid medium used: distilled water, fluoride alcoholic mouthwash, and fluoride non-alcoholic mouthwash. Archwires were soaked in the medium for 1.5 hours at 37°C, after which three-point bending tests were carried out by the help of a universal testing machine, and load deflection data were analyzed statistically using one-way ANOVA and Tukey’s post-hoc tests.

Results: Significant increases in load-deflection in stainless steel, Cu-NiTi, β-Ti, and aesthetic archwires were seen using fluoride-containing mouthwash, suggesting stiffness enhancement. The most changes in stiffness were noted in aesthetic and Cu-NiTi wires, but not for Ni-Ti archwires which showed no significant change.

Conclusions: Fluoride-containing mouthrinses exert material-dependent effects on orthodontic archwires, with alcoholic formulations producing the greatest alteration. Ni-Ti wires showed superior stability, whereas aesthetic and Cu-NiTi wires were most affected.

Effect of choline-stabilized orthosilicic acid versus vitamins C and E on peri-implant procollagen type I N-terminal propeptide levels in smokers receiving dental implants: a randomized clinical study

2026-08-14T09:43:30+0530

Background: Smoking adversely affects peri-implant wound healing, osseointegration, and crestal bone stability through increased oxidative stress and impaired bone metabolism. Nutritional supplementation with bone-forming and antioxidant agents, such as choline-stabilized orthosilicic acid (ch-OSA) and vitamins C and E, may improve implant outcomes in smokers; however, comparative evidence remains limited.

Methods: Twenty-eight smokers undergoing dental implant placement were randomly allocated into two groups. Group A received ch-OSA, while group B received combined vitamin C and vitamin E supplementation for one month postoperatively. Clinical parameters, including plaque index (PI), gingival index (GI), wound healing index (WHI), and implant stability quotient (ISQ), were recorded at baseline and 3 months. Crestal bone levels were assessed using standardized intraoral periapical radiographs at baseline, 1 month, and 3 months. Peri-implant crevicular fluid samples were collected on days 7, 15, and 30 to measure procollagen type I N-terminal propeptide (PINP) levels using ELISA.

Results: Both groups showed significant improvements in clinical parameters and implant stability over time (p<0.05), with no significant intergroup differences. Although crestal bone loss occurred in both groups, significantly greater bone loss was observed in the vitamin C and E group at 1 and 3 months (p<0.05). PINP levels increased significantly in both groups, with consistently higher values in the ch-OSA group (p<0.05).

Conclusions: Ch-OSA supplementation promoted greater bone formation activity and reduced crestal bone loss compared with vit C and E supplementation, suggesting superior support for early peri-implant healing in smokers.

Coronary artery disease treatment strategies and long-term renal function: rationale and design of the cardiorenal study

2026-08-14T09:43:29+0530

Background: Treatment strategies for coronary artery disease (CAD), namely coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI) and optimized medical therapy (OMT), have well established cardiovascular outcomes, but their long-term effects on renal function remain underexplored. Patients with chronic kidney disease (CKD) are frequently underrepresented in large trials, and renal endpoints are usually treated as markers of cardiovascular risk rather than as outcomes in their own right. This article reports the rationale and design of a study evaluating the long-term renal impact of these strategies.

Methods: Single-centre, registry-based cohort study using the Medicine, Angioplasty or Surgery Study (MASS) registry, reported per the STROBE Statement. Eligible patients have stable multivessel CAD, preserved left ventricular function and annual serum creatinine over more than five years, and received OMT, CABG or PCI. The primary outcome is the longitudinal change in estimated glomerular filtration rate (eGFR) over five years; secondary outcomes are new-onset CKD, advanced CKD, renal replacement therapy and mortality. Renal-function trajectories will be modelled with generalized additive models for location, scale and shape (GAMLSS) including a random intercept per patient; time-to-event outcomes with Cox models adjusted for age, sex, diabetes, hypertension and baseline renal function. The cohort has been assembled and the vital-status update completed; outcome analyses are ongoing and will be reported separately.

Conclusions: By positioning renal function as a primary outcome, this study may generate evidence to integrate cardiovascular and renal risk into treatment selection for stable multivessel CAD.

Trial Registration: The study is registered at ClinicalTrials.gov (NCT07195747).

Efficacy of artificial intelligence‑integrated emotional granularity growth at improving resilience and quality of life in young and middle aged colorectal cancer survivors: protocol for a pilot randomised controlled trial

2026-09-17T07:03:34+0530

Background: Young and middle-aged colorectal cancer survivors frequently experience emotional distress and difficulties adapting during the cancer trajectory. Emotional granularity, the ability to identify and differentiate emotional experiences, may represent a modifiable target for improving emotion regulation and resilience. However, interventions targeting emotional granularity among colorectal cancer survivors remain limited. The artificial intelligence-integrated emotional granularity growth program (AI-EGG), delivered via a WeChat mini program, was developed to enhance resilience and quality of life.

Methods: A two-arm pilot randomised controlled trial will evaluate the feasibility, acceptability, and preliminary efficacy of AI-EGG among young and middle-aged colorectal cancer survivors. Fifty-four participants will be randomly assigned (1:1) to either the intervention group or usual care across three teaching hospitals in Suzhou, China. The intervention group will receive a four-week AI-EGG intervention consisting of emotion identification and differentiation, selection of regulation strategies, implementation of regulation strategies, and maintenance and adaptation. Primary outcomes include recruitment, retention, adherence, ecological momentary assessment completion, and system usability. Secondary outcomes will include resilience, emotional granularity, emotion regulation, and quality of life. Assessments will occur at baseline, post-intervention, and one-month follow-up. Semi-structured interviews with a purposive subsample will explore acceptability and implementation experiences. Ethical approval has been obtained from the Human Subjects Ethics Sub-Committee of The Hong Kong Polytechnic University and participating hospitals.

Conclusions: This study will evaluate the feasibility, acceptability, and preliminary efficacy of AI-EGG for young and middle-aged colorectal cancer survivors and inform intervention refinement and a future definitive trial.

Trial Registration: The trial is registered at ClinicalTrials.gov (NCT07611071).

The effect of back massage with mentholated ointment on pain and anxiety after coronary artery bypass graft surgery: a randomized controlled trial protocol

2026-10-27T07:02:03+0530

Background: This study summarizes the protocol of a randomized controlled trial designed to evaluate the effectiveness of back massage with a mentholated ointment on postoperative pain and anxiety in patients undergoing coronary artery bypass graft (CABG) surgery.

Methods: This study is a prospective, interventional, three-arm randomized controlled non-pharmacological clinical trial. Eligible patients will be randomly assigned to one of three groups. The study population will consist of 120 patients who have undergone CABG surgery in the cardiovascular surgery ward of a teaching and research hospital in Türkiye. Following surgery, patients in group 1 (n=40) will receive back massage with a mentholated ointment, group 2 (n=40) will receive back massage with paraffin oil, and group 3 (n=40) will receive routine clinical care.

Conclusions: The primary outcomes are postoperative back pain intensity and state anxiety levels. Secondary outcomes include vital signs and analgesic use.

Trial Registration: ClinicalTrials.gov identifier: NCT07508371.

Reliability and reproducibility of computed tomography-based facet joint measurements in patients with AO spine type A2, A3 and A4 thoracolumbar fractures: protocol for the REFACT study

2026-10-27T07:01:58+0530

Background: Computed tomography (CT) is widely used to assess facet joint (FJ) degeneration. However, previous studies have reported inconsistent interobserver agreement for the Pathria classification, while the reproducibility of quantitative FJ measurements remains insufficiently investigated. The REFACT study aims to evaluate the interobserver and intraobserver reliability of CT-based FJ assessment in patients with AO spine type A2, A3, and A4 thoracolumbar fractures.

Methods: REFACT is a single center, multiobserver reliability study using retrospectively collected, anonymized CT datasets. Six independent raters (three neurosurgeons and three radiologists) will assess at least 142 evaluable FJs using a standardized protocol. Assessments will include Pathria grading, mean FJ-space width, and FJ angle measurements. Each rater will perform two assessment rounds with randomized case order and a one-month washout interval. Interobserver and intraobserver reliability will be evaluated using intraclass correlation coefficients (ICC) for continuous measurements and Fleiss’ kappa or weighted kappa coefficients for ordinal grading, with 95% confidence intervals. Exploratory analyses will assess agreement by specialty, vertebral level, and side. Patient-level clustered bootstrap analyses will account for within-patient correlation.

Conclusions: The REFACT study will establish the reproducibility of CT-based FJ grading and morphometric measurements, identify potential limitations of the standardized assessment protocol, and provide a methodological basis for subsequent longitudinal studies of FJ degeneration following thoracolumbar fractures.

Trial Registration: ClinicalTrials.gov, NCT07670039.

Adaptive clinical trial with pharmacokinetic-guided optimization of weight-based oral montelukast dose in children with acute asthma exacerbations

2026-10-27T07:01:50+0530

Background: Children with acute asthma exacerbations are frequently hospitalized due to insufficient response to inhaled β-agonist and systemic corticosteroid treatments. Leukotriene (LT) mediated airway inflammation does not respond to these medications and contributes to insufficient clinical response that often necessitates hospitalization. Montelukast (MK) is a potent LT receptor antagonist, and IV MK caused rapid clinical improvement in adults with exacerbations, though the IV form is not FDA approved or currently available.

Methods: This is a phase 2, adaptive, double-masked RCT of high-dose oral MK, with escalating mg/kg dose levels informed by PK-guided modeling, added to standard treatment versus standard treatment alone, in children with exacerbations that are moderate or severe after initial treatment with inhaled albuterol. Study hypotheses are that-High-dose oral MK achieves peak plasma levels (C_max)>1,700 ng/ml in >86% of at least one of three sequential participant groups with escalating weight-based (mg/kg) doses between groups; participants randomized to high-dose oral MK have a 2 point or greater improvement of the validated acute asthma intensity research score (AAIRS) at 4 hours post-treatment in comparison with control group participants; and among MK recipients, C_max correlates with change of the AAIRS at 4 hours, after adjustment for pre-treatment exacerbation severity, respiratory viral detection, and systemic LT stress measured using plasma LTE₄.

Conclusions: This research will provide critical data for dosing and design decisions for a future randomized trial sufficiently powered to definitively determine efficacy in this population.

Trial Registration: NCT 05819541.

Comparative efficacy of nebulised salbutamol, salbutamol plus budesonide and salbutamol plus fluticasone in the management of acute exacerbation of bronchial asthma in children: a study protocol of a randomized controlled trial

2026-10-27T07:02:01+0530

Background: Acute exacerbation of asthma in children is one of the most common emergencies in children. Use of inhaled corticosteroids (ICS) in combination with bronchodilator as initial therapy has shown to be beneficial when compared to oral corticosteroids. ICS commonly used in acute exacerbation in children are budesonide and fluticasone. Pediatric respiratory assessment measure (PRAM) Score is widely used standardized score in clinical and as well in research studies for 2-17years children. It has five parameters with total scores from 0-10 where higher scores indicate sicker patient.

Methods: This study is planned to study efficacy of nebulised salbutamol vs salbutamol plus budesonide vs salbutamol plus fluticasone in management of acute exacerbation of asthma in children. After written informed consent, participants will be enrolled by computerized block randomization list to three groups. Each group will be administered the medication as per their allocation and weight band. Vitals and PRAM score will be recorded 0, 2 and 4 hours from the start of treatment. PEFR will be recorded with help of peak flowmeter at 2 hours and 4 hours from initiation of treatment. At the end of 4 hours, patient outcome will be noted. After 3 months, child will be followed to know level of control of symptoms as per GINA guidelines. Concealment will be disclosed after statistical analysis performed and results are locked.

Conclusions: If this intervention study shows evidence of a significant difference between three arms of treatment, then it may guide first line of treatment of acute exacerbation of paediatric asthma.

Trial Registration: CTRI/2023/07/054624 registered prospectively.

Efficacy of add-on Dusparshadi Kashaya and Chandraprabha Vati in the management of grade 2 to 3b chronic kidney disease: a structured study protocol of open labelled randomized standard controlled clinical trial

2026-10-27T07:03:05+0530

Background: Chronic kidney disease (CKD) is a progressive disorder characterized by persistent renal dysfunction, commonly associated with diabetes mellitus and hypertension. Despite advances in conventional management, CKD remains a major global health burden due to its progressive course and complications. In Ayurveda, its clinical manifestations may be correlated with Vrikkaroga described in Bhaishajyaratnavali.

Methods: This single-center, open-label, randomized, standard-controlled clinical trial will enroll participants with grade 2-3 B CKD diagnosed according to kidney disease quality of life (KDIGO) 2024 guidelines. Eligible participants will be randomly allocated to an intervention or control group. The intervention group will receive standard medical treatment plus Dusparshadi Kashaya (120 mL twice daily before meals) and Chandraprabha Vati (500 mg, two tablets twice daily after meals) for 60 days, while the control group will receive standard medical treatment. The primary outcome will be the change in estimated glomerular filtration rate (eGFR) from baseline to day 60. Secondary outcomes will include changes in serum creatinine, serum urea, hemoglobin, and quality of life assessed using the KDQOL™-36 questionnaire. Additional outcomes will include dialysis requirement and mortality. Data will be analyzed using statistical tests, with p<0.05 considered statistically significant.

Conclusions: This study will assess the efficacy and safety of Dusparshadi Kashaya and Chandraprabha Vati as adjuncts to standard care in grade 2-3b CKD and may provide evidence for their potential to improve renal function, quality of life, and clinical outcomes.

Trial Registration: The trial is registered with the Clinical Trials Registry of India (CTRI) (CTRI/2026/05/110662).

A study protocol for assessing the efficacy of add-on Brihatkataphaladi Vati, Vasadi Kashaya and polyherbal nebulization in the management of chronic obstructive pulmonary disease: a randomized placebo-controlled clinical trial

2026-10-27T07:01:59+0530

Background: Chronic obstructive pulmonary disease (COPD), correlated with Tamaka Shwasa in Ayurveda, is a major global health concern characterized by persistent airflow obstruction. Conventional treatment provides symptomatic relief and reduces exacerbations but has limited effects on disease progression. Ayurveda interventions with potential anti-inflammatory, mucolytic, and broncho-dilatory properties may offer complementary benefits. This study aims to evaluate the efficacy and safety of add-on Brihatkataphaladi Vati, Vasadi Kashaya, and polyherbal nebulization alongside standard care in COPD.

Methods: This randomized, placebo-controlled, parallel-group clinical trial will include 50 clinically stable COPD patients classified as GOLD Grades I-III. Participants will be randomly allocated into two groups of 25 each. The intervention group will receive Brihatkataphaladi Vati, Vasadi Kashaya, and polyherbal nebulization alongside standard care, whereas the control group will receive placebo alongside standard care. Treatment will continue for 90 days, with weekly follow-ups and two post-treatment follow-up visits. The primary outcome will be the change in COPD symptom severity measured using the COPD assessment test (CAT) score. Secondary outcomes will include changes in forced expiratory volume in one second (FEV₁), FEV₁/FVC ratio, exacerbation and hospitalization frequency, rescue medication use, Ayurvedic symptom scores, and safety parameters assessed through clinical monitoring and laboratory investigations. Outcomes will be assessed at baseline and post-treatment. Appropriate statistical tests will be applied, with p<0.05 considered statistically significant.

Conclusions: The study is expected to provide evidence regarding the efficacy and safety of this integrative therapeutic approach in improving symptoms and pulmonary function in COPD patients.

Trial Registration: The trial is registered with Clinical trial registry of India (CTRI) CTRI/2026/05/110230.

A study protocol for assessing the efficacy of Nagabala-Arjunadi Yoga and Arogyavardhini Rasa in the management of post-myocardial infarction as an add-on to the standard care: a standard controlled clinical trial

2026-10-27T07:01:51+0530

Background: Myocardial infarction (MI) is a major cause of cardiovascular morbidity and mortality. Despite advances in reperfusion and standard pharmacological management, patients may develop left ventricular dysfunction, adverse cardiac remodelling, recurrent ischemic symptoms, reduced functional capacity, and impaired quality of life. Nagabala-Arjunadi Yoga has shown beneficial effects on cardiac symptoms, left ventricular ejection fraction (LVEF), and quality of life in previous study. Arogyavardhini Rasa, with its Hridya (Cardioprotective), Lekhana (Scraping action), and Medohara (Hypolipidemic) properties, may provide additional cardiovascular benefits. However, evidence regarding their combined efficacy in post-MI management remains limited. Objectives were to evaluate the efficacy of Nagabala-Arjunadi Yoga and Arogyavardhini Rasa as add-on to standard care in post-MI patients.

Methods: This prospective, open-label, randomized, standard-controlled clinical trial will enrol 106 post-MI patients. Participants will be allocated to receive either Nagabala-Arjunadi Yoga and Arogyavardhini Rasa alongside standard care or standard care alone for 12 weeks. Primary outcomes will include changes in LVEF, left ventricular end-diastolic volume (LVEDV), left ventricular end-systolic volume (LVESV), N-terminal pro-B-type natriuretic peptide (NT-proBNP), angina severity, fatigue, dyspnoea, and functional capacity. Health-related quality of life (HRQoL) will be assessed using the MacNew questionnaire as a secondary outcome. Assessments will be performed at baseline and post-treatment. Appropriate parametric and non-parametric statistical tests will be applied, with p<0.05 considered statistically significant.

Conclusions: The study will evaluate whether these Ayurvedic formulations, as add-on to standard care, improve cardiac function, remodelling parameters, NT-proBNP levels, ischemic symptoms, functional capacity, and quality of life in post-MI patients.

Trial Registration: The trial is registered with Clinical Trial Registry of India (CTRI). CTRI/2026/07/114947.