International Journal of Clinical Trials

Correlation of statin therapy and severity of diabetic retinopathy at a tertiary care hospital in Northern India: a randomised control trial

2025-01-28T21:40:13+0530

Background: Aim was to study the correlation between statin therapy and the severity of diabetic retinopathy.

Methods: A randomised control trial was performed at a tertiary care hospital in northern India. The severity of diabetic retinopathy was compared between statin and non-statin users from the fundus examination and medical records of patients presenting to the Outpatient department from July 2022 to May 2023. A total of 100 patients with diabetic retinopathy were enrolled in the study, all meeting the inclusion criteria. The patients were divided into statin users and nonusers. The results were analysed to compare the severity of DR between the two groups.

Results: Out of 45 statin users, 28 (62.2%) had mild non-proliferative diabetic retinopathy (NPDR), 10 (22.2%) had a moderate grade of NPDR, 5 (11.1%) had severe NPDR, 1 (2.22%) had PDR and 1 (2.22%) patient had diabetic macular edema (DME). Out of 55 non-statin users, 10 (18.18%) had mild diabetic NPDR, 16 (29.09%) had a moderate grade of NPDR, 16 (29.09%) had severe NPDR, 8(14.54%) had PDR and 4 (7.27%) patients had DME and 1 (1.81%) patient presented with both DME and vitreous haemorrhage (VH).

Conclusions: In type 2 diabetic patients, patients on statins had significantly lower grades of retinopathy as compared to those who were not taking statins. Thus, statins can be given prophylactically to lower the severity of diabetic retinopathy.

Pattern of abnormal uterine bleeding in a tertiary care hospital

2025-01-28T21:40:01+0530

Background: Abnormal uterine bleeding (AUB) is a significant clinical entity. Aim of the study was to observe the pattern of AUB in tertiary care hospital.

Methods: All patients attending gynae OPD and ward presenting with AUB were included in the study.

Results: A total 640 women had AUB in one year of study period. Highest incidence of AUB is observed in the age group 40-49 years. The most common clinical presentation of AUB was metrorrhagia followed by polymenorrhoea, menorrhagia, menometrorrhagia, oligomenorrhoea and hypomenorrhoea. On ultrasonography the commonest finding was leiomyoma uterus (28.15%) followed by increased endometrial thickness (18.46%). The most common histological pattern was proliferative endometrium (34.10%). According to PALM-COEIN classification the maximum incidence found was of AUB-L followed by AUB-O.

Conclusions: The prevalent causes of AUB vary with age. So, all the patients presenting with AUB to gynaecology departments were included in the study irrespective of age. The information presented in this study adds to our understanding of patterns of the AUB.

Clinical trials unveiled: an overview of key concepts, strategies and challenges

2025-01-28T21:40:11+0530

Carrying out clinical trials is essential for pushing forward the cause of medical science in that such is a stance from which it is possible to provide the proofs necessary for sanctioning new treatment methods including making sure they are safe and generally efficient. Clinical research help researcher to discover new medications to treat, prevention, mitigation of prevailing disease. Because of clinical trial many effective treatments in field of disease, vaccines are available which are quite more effective than the marketed drugs. It can also be said that the clinical research would not be successful without participating subjects. The participating volunteers are irrespective of healthy or have a medical condition. People of any age and backgrounds can participate in the trial. Usually, clinical trials are characterized by multiple problems such as poor recruitment, ethical problems, regulatory issues, and exorbitant prices. The present paper gives a glimpse of the manner in which clinical trials are usually followed, the stages that are typically covered throughout, not forgetting, the most crucial barriers which are involved.

Safety and efficacy of high dose buprenorphine initiation in fentanyl positive emergency department patients

2025-01-28T21:40:09+0530

Background: The safety and efficacy of high dose buprenorphine (BUP) induction in fentanyl positive emergency department patients (high dose BUP) study includes two clinical trials funded through the helping to end addiction long-term^SM initiative. The study tests whether initiation and continuation of BUP at higher doses and over a shorter time period than currently recommended is safe, tolerable and effective.

Methods: Trial 1 is a head-to-head comparison of the safety, tolerability and feasibility of high dose BUP initiation (32 mg) and continuation (24 mg) as compared to standard dose BUP initiation (12 mg) and continuation (16 mg). Trial 2 is a small pilot multicenter randomized, double blind clinical trial in 80 participants, randomized 1:1, that will provide preliminary efficacy data. The primary outcome measure for trial 1 is the frequency of dose treatment-emergent adverse events (TEAEs) grade 3 (per common terminology criteria for adverse events v5.0 (CTCAE v5.0)), including but not limited to bradypnea <8, oxygen saturation<88% on room air and/or rescue naloxone administration. The primary outcome measure for trial 2 is the proportion of participants engaged in comprehensive addiction treatment at 7-days post ED initiation.

Conclusions: The results of these trials will provide crucial data on the safety, feasibility and efficacy of high-dose ED BUP initiation and continuation in fentanyl positive ED patients and inform incorporation of high-dose BUP initiation into ED care for patients with OUD.

Trial registration: ClinicalTrials.gov ID: NCT05589181

The effect of sleep hygiene training given to epilepsy patients on seizure frequency and sleep quality: pre-test post-test control group experimental study protocol

2025-01-28T21:40:25+0530

Background: Epileptic seizures develop with hyper-synchronization of neuronal networks, causing insomnia, and sleep quality decreases with drug treatment. Insomnia, which occurs with decreased sleep quality, increases epileptic seizure discharges. This study/trial aims to determine the effect of sleep hygiene education given to epilepsy patients on seizure frequency and sleep quality.

Methods: It is non-pharmacological clinical research and was conducted experimentally with a pretest-posttest control group experimental model. Randomization was done using simple random selection. The routine treatment of the first experimental group (n=80 people) continued. Patients were provided with sleep hygiene training, a sleep hygiene training booklet, and an educational video for those who requested it. In the three-month follow-up, sleep hygiene training was repeated in the monthly meetings. The second group, the control group (n=80), continued routine treatment, and no intervention was made for three months. In the planned monthly meetings, sleep quality was evaluated using the PSQI (Pittsburgh sleep quality index). In the monthly meetings, the seizure schedule recorded by the patients and the frequency of seizures were evaluated together with the patients.

Results: In this study, data collection began on June 1, 2023, and the data collection process ended on May 21, 2024, while the data analysis process is ongoing.

Conclusions: With this trial/study, the evidence-based use of sleep hygiene education's effectiveness on the seizures and sleep quality of epilepsy patients will be evaluated.

Trial registration: The trial was registered in clinical trials: (ClinicalTrials.gov Identifier: NCT06352476). Registered on: 10881-669.

Cannabidiol for treatment of irritability and aggressive behavior in children and adolescents with autism spectrum disorder: background and methods of the cannabidiol study in children with autism spectrum disorder study

2025-01-28T21:40:06+0530

Background: Autism spectrum disorder (ASD) is a neurodevelopmental disorder commonly associated with behavioral challenges. There are few evidence based pharmacological interventions available for the treatment of behavioral symptoms associated with ASD. Cannabidiol (CBD), the non-intoxicating component of cannabis, has known neuroprotective, antiepileptic, anxiolytic, and antipsychotic effects and may be useful in treating the behavioral symptoms of ASD.

Methods: We describe the research methods of a 27-week randomized placebo-controlled crossover trial to evaluate the safety and efficacy of oral CBD for the treatment of irritability and aggression associated with ASD, as measured by the irritability subscale of the aberrant behavior checklist-2^nd edition (ABC-2) in children and adolescents.

Conclusions: There is significant need for clinical research exploring alternative medications for the treatment of behavioral symptoms of ASD. Upcoming results from this trial will help answer the question of whether CBD may be a useful intervention in the management of ASD.

Clinical trial registry: NCT04520685.

Effects of LI.4 acupressure and cold application on behavioural responses to pain and physiological parameters among infants receiving intramuscular injection: a randomized controlled trial protocol

2025-01-28T21:40:21+0530

Background: Vaccination protects children from many diseases. However, it often causes anxiety and distress for them despite its benefits. This trial aims to assess the effect of acupressure (Li.4) and cold application on pain and physiological parameters in children getting intramuscular injections.

Methods: The study is designed as a randomized controlled trial with a crossover approach. Participants who meet the inclusion criteria will be randomly divided equally into two groups. Group I (85) and Group II (85). Using Sequentially Numbered Opaque Sealed Envelops (SNOSE), each infant will act as their own matched control. In the first sequence, group I will receive acupressure, and group 2 will receive cold application. In sequence 2, interventions will be switched. Pain level and infant distress will be measured using NIPS and infant distress scale respectively, physiological parameters, such as oxygen saturation and heat rate, will also be recorded using pulse oximeter.

Conclusions: Reducing vaccination pain helps prevent long-term negative effects on children’s health. Practitioners are responsible for managing pain during procedures using simple and cost effective and quick relief methods.

Trial Registration: CTRI: CTRI/2023/11/060179.

The effectiveness of nurse-led visual rehabilitation on visual outcome among post-operative patients of sellar/suprasellar tumours-protocol of a randomized controlled trial

2025-01-28T21:40:16+0530

Background: Tumour or mass of the suprasellar region are common pathologies and are also important due to their adjacency to the vital anterior visual apparatus. They may cause serious ocular signs and symptoms in addition to neurological complications resulting from increased intracranial pressure, cranial nerve impairment, or brain compression. Increased ICP may lead to headache, double vision and loss of peripheral vision, can lead to sinus pain or ear pain, drooping eyelid and seizures. After surgery, patients may continue to experience neuropsychological symptoms, physical symptoms and develop complications.

Methods: Randomized controlled trial. A computer random table with allocation concealment will be used to recruit and assign patients with visual complaints resulting from sellar/suprasellar tumors operated on at PGIMER to the experimental and control groups. Enrolment will be done on 5^th to 7^th day of surgery and intervention will be provided on the same day until discharge and booklet with nurse-led visual rehabilitation will be provided for continuous practice at home. The post-op follow-up will be done at 1 month and 3^rd month of surgery.

Conclusions: This aim of the study is to determine the effectiveness of “nurse-led visual rehabilitation” on visual outcome among post-op patient with sellar/suprasellar tumours at 1 month and 3 months. The comprehensive nurse-led visual rehabilitation will be designed with the inputs from all nursing and clinical specialist in neurosurgery and ophthalmology, has the ability to work well with the dynamic care of postoperative patients experiencing visual problems from suprasellar and sellar tumors.

CTRI registration number: CTRI/2023/08/056030 ON 2/8/23

Effect of biopsychosocial comprehensive chronic pain management physiotherapy practice protocol in patients with chronic musculoskeletal pain-a randomised control trial

2025-01-28T21:40:04+0530

Background: Chronic musculoskeletal pain (CMP) is a common condition treated by physiotherapists. Many existing treatments focus mainly on biomedical aspects, which have limited effectiveness and do not align with clinical practice guidelines that advocate for a biopsychosocial (BPS) approach. To address this issue, a new physiotherapy protocol has been developed that incorporates pain neurophysiological education, cognitive behaviour modification, and self-management strategies. This protocol will undergo clinical trial evaluation and has the potential to transform physiotherapy practices in line with these guidelines.

Methods: A randomised, single-centre clinical trial will be carried out to compare the effect of a comprehensive CMP management (CCPM) which consists of 16 sessions weekly twice for 8 weeks neuroscience education program (4 sessions, 4 hrs) cognitive behaviour modification program (6 sessions, 6 hrs), self-management strategies (4 sessions, 4 hrs) and revision of the program (2 sessions, 2 hrs) along with usual care physiotherapy treatment for thrice weekly for 8 weeks, with standardised physiotherapy thrice weekly for 8 weeks as control group. The study aims to evaluate the effect of CCPM intervention on central sensitisation, as well as on fear avoidance, pain, disability, and pain self-efficacy The outcome variables will be measured at the beginning of the intervention and after 8 weeks.

Discussions: The Physiotherapy practice must adopt a multi-dimensional pathway of treatment that considers all the bio-psychosocial factors during treatment sessions, rather than just following a bio-model pathway of management.

Trial registration: CTRI/2023/05/053340 [Registered on: 31/05/2023]

Determination of minimal inhibitory concentration of citric acid as a root canal irrigant against E. faecalis and C. albicans

2025-01-28T21:39:59+0530

The clinical success of primary teeth endodontic therapy depends strongly on attaining prepared root canals with sufficient disinfection levels. Therefore, using natural or chemical cleaning agents to properly clean the root canals is becoming more and more important. With little to no impact on the organic components, citric acid is effective in dissolving the smear layer and the inorganic components of root dentine. Study included the custom preparation of citric acid to 3 different concentrations-6,8, and 10%. MTCC strains of C. albicans and E. faecalis were cultured on Sabouraud Dextrose agar plates and blood agar respectively. Three wells each were prepared on cultured plates and the solutions of citric acid was inoculated into them. The zone of inhibition was noted after 24 hours in each plate. The greatest zone of inhibition will be determined in each of the plates and the concentration was recorded with E. Faecalis and C. Albicans. The lowest concentration of citric acid that is capable of inhibiting bacterial growth will be taken as the minimum inhibitory concentration of citric acid against the respective organism. 8% concentration of citric acid can be used as an irrigant and gives a greater inhibition zone almost as much as that of 10 % citric acid.

Delayed diagnosis of thoracic spine tuberculosis: a learning objective in primary care

2025-01-28T21:40:23+0530

Spinal tuberculosis (TB) constitutes 2% of all TB cases and is a common of all extrapulmonary TB. Despite high prevalence of TB worldwide, it is still sub-optimally controlled owing to the factors like poverty, rising human immuno-deficiency virus (HIV) infection and other chronic illnesses, drug misuse, population surge in developing countries and global migration. This case report presents a 38-year-old man who presented with recurrent chronic thoracic back pain. Further investigation in his third visit revealed a compression fracture of T7-8 vertebrae, with a pathologic fracture with spondylitis, epidural abscess and spinal cord compression suggestive of an infectious process, with tuberculosis being the primary differential diagnosis. We present our case to highlight the importance of a meticulous history taking and examination at first presentation and how cases of spinal TB should not be overlooked.