| 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
|
|
|
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
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drudayashree11@gmail.com].
- 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.
- 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.
|