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CTRI Number  CTRI/2025/08/093224 [Registered on: 19/08/2025] Trial Registered Prospectively
Last Modified On: 14/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Study to See if Neem Seed Oil Can Cure Women’s Reproductive Infections in North Karnataka 
Scientific Title of Study   Effectiveness of Neem Seed Oil in Treating Lower Reproductive Tract Infections in Women: A Single-Blinded Randomized Controlled Trial in North Karnataka 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Udayashree Voorkara 
Designation  Associate Professor  
Affiliation  KLE Jagadguru Gangadhar Mahaswamigalu Moorusavirmath Medical College and Hospitals 
Address  OPD room no 1, Unit C, MCH Block, Department of OBG, KLE Hubli Cooperative Hospital, Coen Road, Hubballi, Karnataka,India
Department of OBG KLE Jagadguru Gangadhar Mahaswamigalu Moorusavirmath Medical College and Hospitals Gabbur Cross Hubballi 580028
Dharwad
KARNATAKA
580020
India 
Phone  9845960821  
Fax  -  
Email  drudayashree@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Udayashree Voorkara 
Designation  Associate Professor  
Affiliation  KLE Jagadguru Gangadhar Mahaswamigalu Moorusavirmath Medical College and Hospitals 
Address  OPD room no 1, Unit C, MCH Block, Department of OBG, KLE Hubli Cooperative Hospital, Coen Road, Hubballi, Karnataka, India
Department of OBG KLE Jagadguru Gangadhar Mahaswamigalu Moorusavirmath Medical College and Hospitals Gabbur Cross Hubballi 580028
Dharwad
KARNATAKA
580020
India 
Phone  9845960821  
Fax  -  
Email  drudayashree@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Udayashree Voorkara 
Designation  Associate Professor  
Affiliation  KLE Jagadguru Gangadhar Mahaswamigalu Moorusavirmath Medical College and Hospitals 
Address  OPD room no 1, Unit C, MCH Block, Department of OBG, KLE Hubli Cooperative Hospital, Coen Road, Hubballi, Karnataka,
Department of OBG KLE Jagadguru Gangadhar Mahaswamigalu Moorusavirmath Medical College and Hospitals Gabbur Cross Hubballi 580028
Dharwad
KARNATAKA
580020
India 
Phone  9845960821  
Fax  -  
Email  drudayashree@yahoo.com  
 
Source of Monetary or Material Support  
KLE Academy of Higher Education and Research (Deemed-to-be University), Belagavi, Karnataka, India 590010 
 
Primary Sponsor  
Name  KLE Academy of Higher Education and Research  
Address  KAHER (Deemed-to-be University), JNMC Campus, Nehru Nagar, Belagavi, Karnataka, India - 590010 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Udayashree Voorkara  KLE Hubli Co-Operative Hospital  OPD room no 1, Unit C, Department of Obstetric & Gynecology KLE Hubli Co-Operative Hospital,Coen Road, Hubballi, Karnataka, India – 580020
Dharwad
KARNATAKA 
09845960821

drudayashree@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Jagadguru Gangadhar Mahaswamigalu Moorusavirmath Medical College Institution Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N760||Acute vaginitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A - BC Capsule  Group A (Test medications) will be administered Ayurvedic medication, specifically “BC capsules” developed by Nutra Grace in Hyderabad, India (19), which are approved by the Food Safety and Standards Authority of India (FSSAI).  
Comparator Agent  Group B Clingen Forte Vaginal Capsule  Group B (comparator medication) will receive the Clingen Forte Vaginal Capsule, which contains Clindamycin 100 mg, Clotrimazole 100 mg, and Tinidazole 100 mg. According to CDC guidelines, the dosage is administered in divided doses over 6 days. Each capsule is to be inserted vaginally just before bedtime 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  1. Women with lower reproductive tract infections, including vaginitis, cervicitis, and vulvovaginitis (14).
2. Women with the following symptoms: abnormal vaginal discharge, vaginal itching or burning or irritation, painful or uncomfortable intercourse, vaginal odor.
3. Women who are willing to give written informed consent
 
 
ExclusionCriteria 
Details  1. Women who are on infertility treatment and are pregnant/ lactating.
2. Patient who are on anti-retroviral therapy (ART) and/or HIV positive, have taken a course of antibiotic within previous 4 weeks.
3. Women who are allergic to the neem products.
4. Patients who have serious medical conditions and currently on medication 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Clinical Cure rate/ Symptom resolution
It includes the percentage patients who are symptom-free from abnormal vaginal discharge, itching or burning or irritation, painful or uncomfortable intercourse, vaginal odor at the end of treatment. It will be measured through symptom severity scores 0 to 3 signifying none, mild, moderate, or severe, assessed at baseline on 1st visit and at 2nd visit and after treatment during 3rd visit.
 
1st Visit 0th Day
2nd Visit 7th Day
3rd Visit 15th Day  
 
Secondary Outcome  
Outcome  TimePoints 
Microbiological Cure Rate The proportion of patients with no detectable pathogen (e.g., Candida albicans, Bacterial vaginosis, T. vaginalis) in the vulvovaginal tract at 3rd visit and it is compared with 1st visit reports.   1st Visit 0th Day
3rd Visit 15th Day  
Adverse Event Rate The frequency and severity of adverse effects reported by patients during the study- as irritation, burning, discomfort or any other reasons will be done.   1st Visit 0th Day
2nd Visit 7th Day
3rd Visit 15th Day  
Discontinuation Rate The percentage of patients who stop treatment due to adverse effects or other reasons will be noted and calculated   1st Visit 0th Day
2nd Visit 7th Day
3rd Visit 15th Day  
Vaginal Microbiome Changes Any changes in the composition of the vaginal microbiome before and after treatment  1st Visit 0th Day
2nd Visit 7th Day
3rd Visit 15th Day  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drudayashree11@gmail.com].

  6. For how long will this data be available start date provided 01-09-2025 and end date provided 31-10-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  
This research proposal describes a single-blinded, randomized controlled trial comparing the effectiveness of neem seed oil with standard allopathic treatment for lower reproductive tract infections (RTIs) in women at a tertiary care hospital in Hubballi, North Karnataka. The study will involve 100 women, who will be randomly assigned to receive either neem seed oil BC capsules or the standard Clingen Forte vaginal capsule, and followed over a 15-day treatment period. Evaluation will include monitoring symptom resolution, conducting microbiological tests to confirm cure, recording any adverse events, and noting changes to the vaginal microbiome. The research is being led by a multidisciplinary team from both modern and Ayurvedic medical backgrounds, with a focus on rigorous scientific and ethical standards, including participant confidentiality and comprehensive reporting of adverse events.
The study aims to address the significant public health burden of RTIs among Indian women and the limitations of current syndromic management by providing robust clinical data on whether neem seed oil is as effective and safe as existing treatments. The methodology involves strict inclusion and exclusion criteria, single-blind randomization, and structured follow-up visits. All research-related expenses, including medication, diagnostics, and participant compensation, are covered by the KLE Academy of Higher Education and Research Institute. By evaluating both clinical outcomes and safety, the results of this research may help inform the integration of culturally accepted traditional remedies such as neem seed oil into mainstream medical care for women’s reproductive health.

 
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