International Journal of Clinical Trials

Protocol for a triple-blinded randomised sham-controlled pilot trial of multi-session transcranial direct current stimulation for tinnitus alleviation: the WHITBY study

Bas Labree — 2026-04-29

Background: Tinnitus-the perception of sound in the absence of an external source is a common condition, highly impactful condition for which treatment options are limited. Based on the limited available evidence, transcranial direct current stimulation (tDCS) has shown promise for suppressing, or reducing, tinnitus salience. Unlike existing tinnitus interventions, which aim to help patients to better cope with tinnitus, tDCS has the potential to address the tinnitus percept itself.

Methods: Protocol for a triple-blinded randomised sham-controlled pilot trial, aimed at informing a future clinical trial for tDCS-based tinnitus treatment. 40 participants, will be randomised to receive ten sessions of either active or sham tDCS over a 2-week period. Proof of concept will be measured by protocol compliance, attrition, and tolerance. Tinnitus loudness, symptom severity, and other relevant outcomes will be measured using self-report measures and electroencephalography.

Conclusions: The study’s primary aims are to assess the tolerability of multiple tDCS treatments in tinnitus patients by way of treatment adherence and satisfaction, devise an evidence-based protocol and derive a minimum sample size for a future controlled efficacy trial. Secondary aims are to compare different subjective measures of tinnitus, as well as electrophysiological measures of underlying brain activity and to explore the feasibility of individualised head and current flow modelling for the development of future individualised treatment regimens using structural magnetic resonance imaging data acquired in a subset of our patients. The results will yield new insights into tinnitus mechanism and treatment-related changes.

Trial Registration: This study is registered at ClinicalTrials.gov (NCTNCT06628414).

The effects of promoting mentally active sedentary behaviour and physical activity on depressive symptoms: a randomized controlled trial

Alexandre S. Martins — 2026-04-29

Background: Depressive symptoms are linked to poorer health and higher mortality, partly due to non-communicable diseases. While sedentary behavior contributes to these outcomes, its impact may depend on cognitive engagement. Evidence from interventions replacing passive sedentary activities with active or physical alternatives remains limited. Objectives were to evaluate the effects of an intervention replacing mentally passive sedentary behaviors with mentally active sedentary behaviors, light physical activity, or moderate-to-vigorous physical activity on depressive symptoms in adults with subclinical depression.

Methods: This single-center, parallel-group, randomized controlled trial will randomly allocate eligible participants (1:1) to either the intervention or control arm. The intervention group will engage in a 4-month goal-setting program designed to substitute mentally passive sedentary behaviors with mentally active sedentary behaviors, light physical activity, or moderate-to-vigorous physical activity. The control group will attend 4-month individual sessions and receive general guidance based on physical activity recommendations. Depressive symptoms (primary outcome), differentiated sedentary behaviors and physical activity levels, quality of life, body composition, and functional capacity will be evaluated at baseline and after the 4-month intervention. Data will be analyzed using an intention-to-treat approach to maintain randomization integrity, and per-protocol percentage changes will be compared using independent t-tests. All analyses will be conducted by a blinded researcher.

Conclusions: This trial could yield new insights into the benefits of replacing mentally passive sedentary behaviors with mentally active alternatives, light physical activity, or moderate-to-vigorous physical activity for alleviating depressive symptoms in adults with mild to moderate depression.

Trial Registration: This study is registered at ClinicalTrials.gov (identifier NCT07007234).

Design, methods and rationale for the prevention of postpartum urinary retention study: protocol of a randomized controlled trial

Elena Lands — 2026-04-29

Background: Intrapartum bladder overdistension after neuraxial anesthesia can lead to postpartum urinary retention (PUR) as well as long-term voiding dysfunction. This has not yet been assessed as the primary outcome of a randomized controlled trial.

Methods: Patients in labor planning vaginal delivery will be randomized to continuous (CC) versus intermittent catheterization (IC) after receiving neuraxial anesthesia. The primary outcome is urinary retention within three days postpartum, and prespecified secondary outcomes include voiding dysfunction at 2 and 6 weeks via the UDI-6 questionnaire, positive urine cultures within 2 weeks, and patient and nurse satisfaction. We will explain the rationale, review recruitment and screening processes, and describe the interventions, outcome assessments, and planned statistical analyses.

Conclusions: A feasibility trial of ten percent of the planned study population was performed with excellent recruitment and follow-up retention rates. Reasons for protocol deviation were examined and the protocol adjusted as described. Participants of the larger trial will be randomized between December 2025 and May 2026 with final data collection to occur in May 2026. Analyses and submission of results are planned for winter 2026. The prevention of postpartum urinary retention (P-PURE) trial will provide evidence on how bladder catheterization method affects postpartum urinary retention to guide intrapartum catheterization practices.

Trial Registration: Clinicaltrials.gov NCT07125326.

Methods for peripherally inserted central catheter measurement in neonates and children: protocol for a randomized controlled trial

Giulia R. S. Regne — 2026-04-29

Background: Peripherally inserted central catheters (PICC) are widely used in neonates and children requiring intravenous therapy due to their clinical advantages. However, incorrect catheter tip positioning remains frequent and may lead to serious complications. The conventional anatomical landmark–based measurement presents important accuracy limitations. A new approach, the Tomazoni method, has been proposed to improve tip positioning, but current evidence is limited to a small single-center study, highlighting the need for further investigation in broader populations. The objective is to describe a study protocol designed to prospectively evaluate the effectiveness of the Tomazoni measurement method for PICC insertion in neonates and children.

Methods: Study protocol for a pragmatic, parallel-group, double-blind randomized clinical trial. Eligible participants will be neonates and children requiring upper-limb PICC insertion. The control group will undergo the traditional measurement method, while the experimental group will receive the Tomazoni method. Data will be collected using an instrument including patient, procedure, and catheter characteristics. Analyses are planned to involve frequency distributions, association tests, and relative risk. The primary outcome will be the initial catheter tip position.

Conclusions: The findings are expected to contribute to the development of safer and more effective practices in PICC insertion in children and neonates’ populations, supporting patient safety and quality of care in critical neonatal and pediatric environments.

Evaluation of Panchkol Churna against lifestyle modification in cardiovascular risk management: a protocol for an open-label, randomized comparative clinical trial

Khushal Kumar — 2026-04-29

Background: Cardiovascular disease (CVD) remains the leading cause of global mortality, with significant variations in prevalence and mortality rates. Ayurveda advocates the Rasadhatu dushti (RDD) as a component in the development of Hrid rogas. Also, Hridaya has been described as the root (Moola) of Rasavaha srotas, therefore any kind of vitiation in Rasadhatu is liable to affect the heart causing pathologies. The study aims to provide evidence for the role of RDD in CVD and explore integrative approaches to reduce the risk of CVDs.

Methods: This is a study with two phases including a screening and recruitment phase to assess prevalence of RDD with sample size of 390 participants and a clinical trial phase with two groups (A & B) with 30 participants in each group. The participants in group-A will receive Panchkol churna in dose of 3gm for 30 days with Luke warm before meal and group-B will receive life style modification for 30 days. The primary outcome is the assessment of prevalence of RDD in participants at risk of CVDs. The secondary outcome is the changes in Gene expression (Apo-E and IL-6), Framingham risk score (Appendix 2), RAS-RCVD (Appendix 1) score and lipid profile.

Conclusions: This protocol outlines a mixed-method study to investigate the prevalence of RDD in participants at risk of CVD and evaluate the comparative efficacy of Panchkol Churna against lifestyle modification (LSM) as risk reduction measures. The study integrates Ayurvedic concepts with modern clinical markers, such as inflammatory markers (IL-6) and gene expression (Apo-E).

Trail Registration: Clinical Trial Registry of India (CTRI/2023/05/053143).

Scaling up tobacco control in India: a protocol for a hybrid III cluster randomized trial comparing smartphone to in-person training to implement a tobacco control program for school teachers

Mangesh S. Pednekar — 2026-04-29

Background: Low-and middle-income countries (LMICs) face increasing tobacco-related deaths. India is second in global tobacco use, with 29% adult users. Logistical challenges with in-person training in LMICs limit scale-up of tobacco control evidence-based interventions (EBIs). The Tobacco Free Teachers-Tobacco Free Society (TFT-TFS) program was previously shown to help teachers quit tobacco and schools adopt tobacco control policies. We are comparing smartphone-based training to in-person training to scale up the TFT-TFS program.

Methods: Hybrid III cluster-randomized comparative effectiveness trial, involving 200 high schools and high secondary schools in Madhya Pradesh, India. To implement the TFT-TFS program, researchers randomly assigned schools to either smartphone-based (n=110 schools) or in-person (n=90 schools) training arms. Trained teachers from both arms implement the program in their respective schools. We will examine differences in program implementation, reach, and effectiveness between schools from the two arms. Post-implementation mixed-methods will employ the consolidated framework for implementation research (CFIR) to identify contextual factors influencing implementation.

Conclusions: This study will scientifically and economically evaluate smartphone-based training to expand the use of EBIs for tobacco control in LMICs. Analyzing the contextual influences on TFT-TFS use in each training program will allow this work to create actionable guidance for education departments and groups involved in implementing smartphone-based training. These findings will help the CFIR strengthen its evidence on how to implement tobacco control EBIs successfully in low-resource environments.

Trial Registration: This study is registered at ClinicalTrials.gov ID: NCT05500235.

Postoperative hypofractionated radiation in cervical and endometrial tumours: phase II study protocol for a prospective phase II non-randomised trial

Prachi Mittal — 2026-04-29

Background: For women with endometrial or cervical cancer treated surgically, presence of adverse histopathological features is associated with increased risk of recurrence. While conventional post-op radiotherapy uses standard fractionation to treat these patients, use of hypofractionation is understudied. Study aims to evaluate long-term safety of hypofractionated post-op pelvic radiotherapy in patients with cervical and endometrial cancers. Primary objectives were to assess 3-year cumulative incidence of late grade ≥2 GI or genitourinary toxicity in patients with cervical or endometrial cancer requiring adjuvant (chemo) radiation treated with hypofractionated radiotherapy.

Methods: Single-arm prospective study wherein patients will receive adjuvant RT to a dose of 39 Gy in 13 fractions, with or without concurrent weekly cisplatin. Vaginal brachytherapy (2 fractions of 6 Gy HDR) will follow EBRT based on indication. Patients will be followed at regular intervals for assessment of toxicity (graded using CTCAE v5.0), pelvic control, and QoL (using EORTC QLQ-C30 and CX24/EN24). Age≥18 years; ECOG performance status ≤2; post-op carcinoma of cervix/endometrium requiring adjuvant radiotherapy with/without concurrent chemotherapy were included. Macroscopic residual disease post-operatively; requirement for extended field radiotherapy; prior chemotherapy for any malignancy and previous pelvic radiotherapy were excluded. Primary endpoint was 3-year cumulative incidence of late grade ≥2 gastrointestinal or genitourinary toxicity, as assessed by CTCAE version 5.0. Sample size was 90.

Conclusions: Recruitment is estimated to be completed by 2027 and results may be published by 2028 after adequate follow up.

Comparative effectiveness of Satipaṭṭhāna-based thought purification therapy, mindfulness-based cognitive therapy and treatment as usual in patients with depressive disorders: study protocol for a three-arm parallel-group superiority randomized controlled trial

Nikapitiye Nandarathana — 2026-04-29

Background: Depression is a significant global public health challenge, and mindfulness-based cognitive therapy (MBCT) is an evidence-based secular intervention for depression; however, it incorporates partially Buddhist mindfulness practices. The Satipaṭṭhāna-based thought purification therapy (SB-TPT) is a structured, seven-week intervention that integrates systematic contemplation of the body, feelings, mind, and mental phenomena based on Theravāda Buddhist meditation teachings. This trial aims to assess the comparative effectiveness of SB-TPT, MBCT, and treatment-as-usual (TAU) in adults diagnosed with depressive disorders.

Methods: This study is a parallel-group, three-arm superiority randomized controlled trial. 92 adults aged 18-45 years, who have been diagnosed with depressive disorders (HAM-D-17 >8 and ≤24) according to ICD-10 and DSM-5-TR, will be recruited from a tertiary-care academic psychiatry centre in Varanasi, India. Participants will be randomized (1:1:1) to: SB-TPT plus TAU; MBCT plus TAU; and TAU alone. The primary outcome is change in clinician-rated depressive symptom severity measured by the HAM-D-17. Secondary outcomes include depressive symptoms (BDI-II), mindfulness (FFMQ-H), quality of life (WHOQOL-BREF), and rumination (RRQ). Assessments will be conducted at baseline, post-intervention, and at the 3-month follow-up. Data will be analyzed using repeated-measures analysis of variance and intention-to-treat principles.

Conclusions: This trial will provide the first randomized evaluation of a structured Satipaṭṭhāna-based intervention compared with MBCT and treatment as usual for depressive disorders. Findings may contribute to understanding the clinical effectiveness of traditionally grounded contemplative approaches within contemporary mental health settings.

Trial Registration: Clinical Trials Registry of India (https://ctri.nic.in): CTRI/2025/05/087988. 30 May 2025.

Resilience selection: a grave potential bias in clinical trials

Milind Watve — 2026-04-29

Physiological and psychological resilience has important implications for health, disease and treatment. Resilience is shown to boost treatment compliance as well as response and thereby reduce mortality. We consider the possibility that individuals having lower resilience are more likely to discontinue treatment in response to side effects of a drug. In randomized control trials (RCT) if a considerable proportion of individuals discontinue from the treatment group because of side effects, the average resilience in the remaining treatment group would be greater. As a result, the frequency or severity of adverse outcomes in the treatment group will be smaller than the control even when the drug has no effect. This bias is more likely to be serious for drugs with more frequent and/or serious side effects, but following intention to treat (ITT) protocols with some additional precautions can help in avoiding it. We suggest testable predictions of the resilience selection bias hypothesis along with ways to quantify and correct for the bias in RCTs. Attempts to detect, measure and correct for the resilience selection bias should be considered necessary for realistic evaluation of drug action in a clinical trial. Retrospective studies are more sensitive to RS bias than RCTs and need to be interpreted carefully.

Two-year prospective single-arm multicenter study results of clinical safety and performance of synthetic ParieteneTM DS composite mesh in ventral hernia repair

Steven Hopson — 2026-04-29

Background: In ventral hernia surgery, using synthetic meshes is the standard of care to provide additional support to weakened or damaged tissues. This study aimed to assess clinical safety and performance of the synthetic Parietene™ DS composite mesh in ventral hernia repair.

Methods: This is a prospective, single-arm, multicenter study including adults undergoing intraperitoneal onlay mesh repair for ventral hernias using Parietene™ DS composite mesh. Patients were enrolled at 6 US sites and evaluated at discharge and 1, 3, 12, and 24 months postoperatively. Primary endpoint was hernia recurrence at 12 months; secondary endpoints included hernia recurrence at 1, 3 and 24 months, adverse device effects and patient quality of life (QoL). Surgeon satisfaction with mesh was also assessed.

Results: A total of 125 patients were included in this study: 70 treated for primary hernias and 55 for incisional hernias; 68 patients underwent laparoscopy, 56 robotic and 1 open surgery. Only 4 (3.3%) hernia recurrences were reported, all within 12 months. No additional recurrences occurred at 24 months. No significant differences were found in hernia recurrence incidence between hernia type or surgery approach sub-groups. No adverse events related to mesh were reported. Patients experienced significant improvement in QoL at 12- and 24-month post-surgery compared to baseline and 1 month. For >95% of procedures, surgeons rated handling, deployment, and introduction of the mesh as easy or very easy.

Conclusions: Parietene™ DS composite mesh use in ventral hernia repair assures a safe profile, low hernia recurrence rate and improvement in patient QoL.

Consumer involvement in cancer clinical trials: an Australian experience

Elizabeth J. Paton — 2026-04-29

Background: Healthcare consumer involvement in clinical research is considered best practice, however its relationship to trial success is ambiguous. There is limited Australian evidence. This study seeks to examine whether consumer involvement is associated with trial success in the Australian Cancer Clinical Research Network (CRN) landscape, with a skin cancer focus.

Methods: Drawing on the theories of evidence-based medicine and implementation research, published data was studied to characterize cancer research consumer involvement, in particular skin cancer. Mature data from skin cancer trials with the same Australian sponsor was studied to identify, define and evaluate specific consumer initiatives for an association with trials that completed. Trial success was measured by sufficient recruitment that was adequate to answer the research question. Data were extracted and tabulated (grouped, deidentified). Using descriptive statistics, a multi-disciplinary expert team synthesized and interpreted the data.

Results: All Australian cancer CRNs demonstrated integrated consumer involvement in their organizational governance and trial operations. During 2008-2020, 56 studies were screened; six studies met the criteria. Four consumer initiatives were described (consumer expertise, trial promotion, trial access, patient safety; with examples). The only metric associated with success was the degree of trial access. Only 2/6 selected studies achieved target accrual. There are several study limitations.

Conclusions: Australian CRNs demonstrated integrated consumer involvement that meets the best-practice policies and standards. Trial accrual is challenging including in Australian skin cancer research. Specific consumer initiatives have been identified and described to support trial sponsor governance and trials operations. Future research is warranted.

Suicide risk in caregivers of patients with schizophrenia

Pratik Shekhar — 2026-04-29

Background: The high risk of suicide among schizophrenic and other severe mental illness patients has been of great concern. It is critical to find effective care interventions to mitigate suicidal ideation and depressive symptoms to enhance patient outcomes, especially when discharged.

Methods: The study was a cross-sectional comparative study that involved a sample of 71 patients with schizophrenia, schizoaffective, or bipolar disorder. There were two groups of participants, namely home care (n=36) and usual outpatient care (n=35). A structured questionnaire was used to collect sociodemographic and clinical data. The Beck scale of suicidal ideation and the Beck depression inventory (BDI) were used to measure suicidal ideation and depression, respectively. The statistical analysis was conducted using relevant parametric tests, with p<0.05 considered statistically significant.

Results: Home care patients had much lower scores on suicidal ideation than patients who were under their regular outpatient care (0.94±4.24 vs. 3.83±5.44; p=0.016). Equally, depression scores were also low when compared with the usual care group (6.14±7.75 vs. 11.17±9.18; p=0.015). The groups did not differ significantly in baseline sociodemographic and clinical features.

Conclusions: Suicidal ideation and depression are lower in the case of severely mentally ill patients with home care services. The introduction of structured home-based psychiatric care can be essential in the preventive strategies of suicide among patients with schizophrenia and associated disorders.

Radiologic characteristics and prognostic outcomes in non-alcoholic fatty liver disease-related versus alcohol-related hepatocellular carcinoma: a comparative cohort study

Kuldeep Singh — 2026-02-17

Background: Non-alcoholic fatty liver disease (NAFLD) has emerged as one of the fastest-growing etiologies of hepatocellular carcinoma (HCC), while alcohol remains a dominant cause of cirrhosis and HCC in India. Differences in tumor morphology, biological behavior, and outcomes between these two etiologies remain inadequately defined in the Indian population. This study aims to compare radiologic features and prognostic outcomes in NAFLD-related and alcohol-related HCC patients.

Methods: This retrospective cohort study conducted at Apex Hospital included 50 consecutive HCC patients evaluated between September 2014 and October 2015. Etiology was classified as NAFLD (n=25) or alcohol-related liver disease (ALD) (n=25). All patients underwent contrast-enhanced computed tomography (CT) or MRI at presentation. Tumor morphology, liver imaging reporting and data system (LI-RADS) imaging features, vascular invasion, extrahepatic disease, and portal hypertension indicators were analyzed. Clinical parameters including serum alpha-fetoprotein (AFP), Child-Pugh and model for end-stage liver disease (MELD) scores, metabolic comorbidities, and treatment modalities were compared. Survival was assessed at 1 and 3 years.

Results: NAFLD-HCC patients were older (mean 62 vs 54 years), had higher rates of diabetes (68% vs 24%), and more often presented with solitary large lesions (mean size 6.1 cm vs 4.2 cm). Alcohol-HCC patients showed significantly higher rates of multifocal disease (56% vs 28%) and portal hypertension markers. Portal vein thrombosis was more common in alcohol-HCC (36% vs 16%). One-year survival was higher in the NAFLD group (68% vs 40%; p<0.05). Three-year survival remained better in NAFLD-HCC (24% vs 8%).

Conclusions: NAFLD-and alcohol-related HCC represent distinct phenotypic and prognostic subtypes. NAFLD-HCC is characterized by large solitary tumors but better liver function and improved short-term survival, while alcohol-HCC exhibits more advanced cirrhosis, multifocal disease, and worse outcomes. Etiology-specific surveillance strategies are warranted.

Effectiveness of warm water sponging versus tepid sponging in stabilization of vital signs and facilitating comfort among children with pyrexia admitted to selected hospitals of Lucknow

Sweta Singh — 2026-04-29

Background: Fever is most common phenomena in all age group as it is associated with various infectious and non- infectious processes interact with the host’s defense mechanism. Sponging the child with tepid have been routinely used in treatment of fever for a long period of time. But it has been seen that tepid sponging develops additional discomfort. The present study aimed to find the relative effectiveness in terms of additional comfort, longer duration of maintaining vital signs and achieving in physiological hemodynamics.

Methods: A quasi-experimental study was conducted among 80 children in selected hospital, Lucknow by using non-probability total enumerative sampling technique. Children’s comfort daisies and visual analogue fatigue scale was used to assess the level of comfort and fatigue.

Results: The comparison between warm water and tepid sponging group in respect of vital signs shows that there was no significant difference (p>0.05) between them at any stage of study. But warm water sponging was more significant (p<0.05) in facilitating comfort than tepid sponging among children with pyrexia.

Conclusions: This study suggests that both warm water sponging and tepid sponging were effective in reduction of vital signs but warm water sponging was more effective in facilitating comfort among children with pyrexia. Whereas in the level of fatigue there was no average changes were obtained.

Robinson cytological grading in breast carcinoma and its correlation with histopathological grading: a five-year retrospective study

Khushboo Sinha — 2026-04-29

Background: Tumor grading is essential for prognosis and treatment planning in breast cancer due to the tumors strong biological heterogeneity. Although histopathological grading is still considered the best method, cytological grading with fine needle aspiration cytology (FNAC) provides a short and non-invasive substitute.

Methods: There were 120 instances of breast cancer identified by FNAC with accessible matched histology in this five-year retrospective research. Modified Bloom-Richardson (Nottingham) (MBR) approach was used to evaluate histopathological grading, whereas Robinson's six-parameter scoring system was used for cytological grading.

Results: The majority of cytologically graded tumors (51.7%) were grade II, followed by grade III (33.3%) and grade I (15.0%). A similar pattern was seen in histopathological grading, with grade II (48.3%) predominating. There was a 72.5% overall cyto-histological concordance, with grade III tumors showing the best agreement (82.5%). As cytological grade increased, lymph node positivity rose from 16.7% in grade I to 75.0% in grade III. A delayed diagnosis was indicated by the majority of tumors (59.2%) measuring between 2 and 5 cm upon presentation.

Conclusions: Robinson's cytological grading method is a straightforward, repeatable, and useful preoperative prognostic tool that has a good connection with lymph node metastases and histological grading.

Assessment and comparison of adverse drug reactions reporting by USFDA and CDSCO: an audit

Laxmi S. Hotkar — 2026-04-29

Background: Drug safety is a critical component not only during the development of pharmaceutical products but also throughout their post-marketing lifecycle. Pharmacovigilance systems play a vital role in monitoring and evaluating adverse drug reactions (ADRs), with many national programs contributing data to the World Health Organization’s Pharmacovigilance Programme headquartered in Uppsala, Sweden.

Methods: The present study aimed to assess and compare ADR reports submitted by various stakeholders in the United States and India. Publicly available pharmacovigilance data from both countries were systematically reviewed and analysed, excluding information related to dyes, medical devices, and blood-related products.

Results: The comparison indicated that the United States Food and Drug Administration (USFDA) receive a substantially higher number of ADR reports compared to India. However, the number of safety alerts issued over the past four years appears to be relatively consistent between the two countries. Antibacterial agents and drugs acting on the endocrine system were among the most frequently reported therapeutic categories.

Conclusions: This study highlights differences in reporting trends and underscores the need for strengthening ADR reporting mechanisms to enhance drug safety monitoring.

Scientific validation of Dhoopa formulations through fumigation in a healthcare setup

Jyoti Sharma — 2026-04-29

Background: Microbial contamination of the air inside a healthcare facility, especially in the outpatient department (OPD) and the operating theatres (OT), is a contributing factor to hospital-acquired infections. Air disinfection is commonly achieved using chemical fumigants, which are associated with health hazards and limited short-term effectiveness, prompting the need to identify safer alternatives. This research was to determine the antimicrobial and air safety of two herbal Dhoopa formulations (DF-I and DF-II) in a medical facility. Aimed at evaluating their performance in reducing airborne bacterial and fungal loads in OPD and OT areas, and at comparing their performance with that of a chemical fumigant (Envipure).

Methods: Dhoopa formulations were made of herbs, cow ghee, camphor, neem, drumstick, mustard seeds, and guggul resin. Fumigation was done in the OPD and OT rooms. The quantity of the bacterial and fungal loads carried by the air was measured by the passive settle plate technique every hour until four hours after the fumigation was carried out. To determine the safety of the air, respirable particulate matter (PM2.5 and PM10) was measured.

Results: Both the DF-I and DF-II exhibited statistically significant (p<0.001) time-dependent decrease in the number of microbes in the air, with the best effect at the fourth hour. Envipure was initially highly efficacious and subsequently declined. The level of particulate matter came back to acceptable levels in four hours of herbal fumigation.

Conclusions: Herbal Dhoopa formulations exhibited long-term antimicrobial activity and acceptable air quality and thus could be used as environmentally friendly alternatives to chemical fumigants in hospitals.