| CTRI Number |
CTRI/2026/03/106396 [Registered on: 17/03/2026] Trial Registered Prospectively |
| Last Modified On: |
15/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A RANDOMIZED CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY OF DARVYADI VARTI AND COMBINATION OF CLINDAMYCIN PESSARY AND CLOTRIMAZOLE IN THE MANAGEMENT OF YONIGATA SHWETASTRAVA leucorrhoea |
|
Scientific Title of Study
|
Randomized Controlled Clinical Trial to Evaluate the Efficacy of Darvyadi Varti Compared with a Combination of Clindamycin Pessary and Clotrimazole in the Management of Yonigata Shwetastrava Leucorrhoea |
| 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 Shubham Ramchandra Omase |
| Designation |
PG Scholar |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
583/2,Tilak Ayurved Mahavidyalaya, 1st Floor, Department of striroga and prasuti department Jagtap Rd, Rasta Peth,Pune, Maharashtra 411002
583/2,Tilak Ayurved Mahavidyalaya, 1st Floor, Department of striroga and prasuti department,Jagtap Rd,Rasta Peth,Pune, Maharashtra 411002
Pune
MAHARASHTRA
411011
India |
| Phone |
9604625804 |
| Fax |
|
| Email |
shubhamomase98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep Manmathrao Musale |
| Designation |
Professor Striroga and Prasuti Department |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
583/2,Tilak Ayurved Mahavidyalaya, 1st Floor, Department of striroga and prasuti department.Jagtap Rd, Rasta Peth,Pune, Maharashtra 411011
583/2,Tilak Ayurved Mahavidyalaya, 1st Floor, Department of striroga and prasuti department,Jagtap Rd, Rasta Peth,Pune, Maharashtra 411011
Pune
MAHARASHTRA
411011
India |
| Phone |
9225632451 |
| Fax |
|
| Email |
dr.musale@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Manmathrao Musale |
| Designation |
Professor Striroga and Prasuti Department |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
583/2,Tilak Ayurved Mahavidyalaya, 1st Floor, Department of striroga and prasuti department,Jagtap Rd, Rasta Peth,Pune, Maharashtra 411011
583/2,Tilak Ayurved Mahavidyalaya, 1st Floor, Department of striroga and prasuti department,Jagtap Rd, Rasta Peth,Pune, Maharashtra 411011
Pune
MAHARASHTRA
411011
India |
| Phone |
9225632451 |
| Fax |
|
| Email |
dr.musale@hotmail.com |
|
|
Source of Monetary or Material Support
|
| seth tarachand ramnath charitable ayurvedic hospital, 580/2 rastapeth pune 411011 |
|
|
Primary Sponsor
|
| Name |
TILAK AYURVED MAHAVIDYALAYA |
| Address |
Tilak Ayurved Mahavidyalaya, 1st floor,striroga and prasuti department, Rastapeth, 583/2, Pune. Pune 411011 |
| Type of Sponsor |
Private medical college |
|
|
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 shubham Ramchandra omase |
Seth Tarachand Ramnath Charitable Ayurvedic Hospital,Pune. |
583,Tilak Ayurved Mahavidyalaya, 1st Floor, Department of striroga and prasuti department ,2, Jagtap Rd, Rasta Peth,Pune, Maharashtra 411002
Pune
MAHARASHTRA |
9604625804
shubhamomase98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe TAMV PUNE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N899||Noninflammatory disorder of vagina, unspecified. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | Drug | Classical | | (1) Medicine Name: clotrimazole and clindamycin pessary, Reference: k.d tripathi book of pharmacology , Route: Vaginal, Dosage Form: Varti/ Suppository, Dose: 100(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | Drug | - | | | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Darvyadi varti, Reference: sushruta uttartantra sthana,chapter 38.verses 27,, Route: Vaginal, Dosage Form: Varti/ Suppository, Dose: 2(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Age between 20- 45 years married female participants complaining of vaginal discharge.
Participants having cervical erosion.
Participants complaining of per vaginal white discharge with itching at vaginal area and staining of undergarments. |
|
| ExclusionCriteria |
| Details |
Pregnant women
known case of sexually transmitted diseases
Known case of anaemia
Known case of diabetes mellitus
known case of Serology positive participantsfor HIV, HbSAg, VDRL
known case of Participants with cervical/ vaginal/ endometrial malignancy
known case of Participants with cervical polyp |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| decrease in symptoms of shwetastrava and kandu symptoms |
5 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| decrease in symptoms of shwetastrava symptoms |
7 day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2026 |
| 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="6"
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 - YES
- What data in particular will be shared?
Response (Others) -
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identiļ¬ed for this purpose.
- 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 [shubhamomase98@gmail.com].
- For how long will this data be available start date provided 01-04-2026 and end date provided 01-11-2027?
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
|
The study will be intervened by the treatment of dravaydi varti and combination of clotrimazole and clindamycin pessary to group A and group B respectively. The efficacy of the therapy will be assessed on the basis of subjective and objective criteria for statistical analysis. Scoring will be designed according to the severity of symptoms. The subjective and objective gradation of symptoms will be done as follows and the intensity of each symptom will be calculated before treatment, after treatment and after follow up. The effect of treatment result will be assessed in regards to clinical signs and symptoms on the basis of grading and scoring system. The signs and symptoms will be assessed by adopting the suitable scoring method. |