| CTRI Number |
CTRI/2025/10/095525 [Registered on: 01/10/2025] Trial Registered Prospectively |
| Last Modified On: |
29/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Testing Marigold Gel Against Clindamycin Gel to Treat Pittaj Yonivyapad (Bacterial Vaginosis) in Women. |
|
Scientific Title of Study
|
Evaluation Of Compartive Efficacy Of Marigold ( Tagetes erecta L.) Vaginal Gel Versus Clindamycin Vaginal Gel In Treatment Of Pittaj Yonivyapad (Bacterial Vaginosis)-A Randomized Controlled Trial. |
| 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 MITALI DABHADE |
| Designation |
PG SCHOLAR |
| Affiliation |
MAHATMA GANDHI AYURVED COLLEGE HOSPITAL AND RESEARCH CENTER SALOD WARDHA |
| Address |
Room No. 9 Department Of Prasuti Tantra And Strirog Mahatma Gandhi Ayurved College, Hospital and Research Centre, Salod(H) Wardha MAHARASHTRA 442001 India Wardha MAHARASHTRA 442001 India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9156004789 |
| Fax |
|
| Email |
drmitalidabhade@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHILPA JAMDADE |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
MAHATMA GANDHI AYURVED COLLEGE HOSPITAL AND RESEARCH CENTER SALOD WARDHA |
| Address |
Room No. 9 Department Of Prasuti Tantra And Strirog Mahatma Gandhi Ayurved College, Hospital and Research Centre, Salod(H) Wardha MAHARASHTRA 442001 India Wardha MAHARASHTRA 442001 India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9769493806 |
| Fax |
|
| Email |
dr.shilpajamdade@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MITALI DABHADE |
| Designation |
PG SCHOLAR |
| Affiliation |
MAHATMA GANDHI AYURVED COLLEGE HOSPITAL AND RESEARCH CENTER SALOD WARDHA |
| Address |
Room No. 9 Department Of Prasuti Tantra And Strirog Mahatma Gandhi Ayurved College, Hospital and Research Centre, Salod(H) Wardha MAHARASHTRA 442001 India Wardha MAHARASHTRA 442001 India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9156004789 |
| Fax |
|
| Email |
drmitalidabhade@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod(H), Wardha Dist Wardha, Maharashtra, India 442001 |
|
|
Primary Sponsor
|
| Name |
MAHATMA GANDHI AYURVED COLLEGE HOSPITAL AND RESEARCH CENTER SALOD WARDHA |
| Address |
Room No. 9 Department Of Prasuti Tantra And Strirog Mahatma Gandhi Ayurved College, Hospital and Research Centre, Salod(H) Wardha, MAHARASHTRA 442001 India Wardha, MAHARASHTRA 442001 India
|
| 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 MITALI DABHADE |
MAHATMA GANDHI AYURVED COLLEGE HOSPITAL AND RESEARCH CENTER SALOD WARDHA |
Room No. 9 Department Of Prasuti Tantra And Strirog Mahatma Gandhi Ayurved College, Hospital and Research Centre, Salod(H) Wardha MAHARASHTRA 442001 India Wardha MAHARASHTRA 442001 India
Wardha
MAHARASHTRA |
09156004789
drmitalidabhade@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Ayurved College, Hospital and Research Centre Institutional Committee, Salod(H) Wardha, Maharashtra 442001 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N74||Female pelvic inflammatory disorders in diseases classified elsewhere. Ayurveda Condition: PITTAJA-YONIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Clindamycin Vaginal Gel-- | Clindamycin Vaginal Gel will be given for intravaginal application for the Bacterial Vaginosis for 7 days in adequate quantity on 30 subjects | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: MARIGOLD (TAGETES ERECTA L) VAGINAL GEL, Reference: RAJNIGHANTU, Route: Vaginal, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2.5(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Patients willing to give written consent to participation in research work.
Diagnosed patients of pittaj yonivyapad (bacterial vaginosis).
Between the age of 18 to 45 years and married irrespective of caste religion and socioeconomic background.
|
|
| ExclusionCriteria |
| Details |
Pregnancy, PNC mother, menstruating women, menopausal women.
Patient diagnosed with PID, pyrexia, diabetes, HIV, and VDRL.
Use of antibiotics or antifungal agents in the past 14 days.
Known allergy to marigold.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the Efficacy Of Marigold (Tagetes erecta L.) Vaginal Gel Versus Clindamycin Vaginal Gel In Treatment Of Pittaj Yonivyapad (Bacterial Vaginosis) |
0th day 5th day 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the Efficacy Of Marigold (Tagetes erecta L.) Vaginal Gel Versus Clindamycin Vaginal Gel In Treatment Of Pittaj Yonivyapad (Bacterial Vaginosis) |
0th day 5th day 7th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/11/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
The volunteer will be informed about the study protocol. Willing participants will be randomly selected as per computer generated table. Clinical research format will be prepared and validated. Prior to the study approval will be taken from IEC MGACHRC Salod (H) Wardha and CTRI registration will be done. After selection each participant will be tested individually and selected according to selection criteria. They are divided into two groups the trial is a open labelled standard control equivalence clinical trial. It will include a 7 days treatment period and assessment during treatment on 0th 5th 7th day and follow up on 14th day. |