| CTRI Number |
CTRI/2025/07/091108 [Registered on: 17/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Treatment On Vaginal White Discharge: To Study The Effectiveness Of Traditional Medicine |
|
Scientific Title of Study
|
Randomised Controlled Clinical Trial To Evaluate Efficacy Of Kasisadi Varti And Pippalyadi Varti In The Management Of Kaphaj Yonivyapada With Special Reference To Vaginal Candidiasis |
| 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 Ravina Shinde |
| Designation |
PG Scholar in Prasuti Tantra Evum Stree Rog |
| Affiliation |
Late Kedari Redekar Ayurvedic Hospital and Research Centre |
| Address |
Stree roga Evum Prasuti Tantra OPD No.: 5 and IPD, Ground floor, Late Kedari Redekar Ayurvedic College, Hospital and Research centre, P-2, MIDC, Shendri Mal, Gadhinglaj -416502, District- Kolhapur
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9423840161 |
| Fax |
|
| Email |
Raveshinde10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarita Harshal Kamate |
| Designation |
MS in Prasuti Tantra Evum Stree Rog |
| Affiliation |
Late Kedari Redekar Ayurvedic Hospital and Research Centre |
| Address |
Stree roga Evum Prasuti Tantra OPD No.: 5 and IPD, Ground floor, Late Kedari Redekar Ayurvedic College, Hospital and Research centre, P-2, MIDC, Shendri Mal, Gadhinglaj -416502, District- Kolhapur
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9881988389 |
| Fax |
|
| Email |
saritakamate9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarita Harshal Kamate |
| Designation |
MS in Prasuti Tantra Evum Stree rog |
| Affiliation |
Late Kedari Redekar Ayurvedic Hospital and Research Centre |
| Address |
Stree Rog evum Prasuti Tantra OPD no.-5 and IPD, ground floor, late Kedari Redekar Ayurvedic college, hospital and research centre, P-2, MIDC, Shendri Mal, Gadhinglaj , district- Kolhapur
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9881988389 |
| Fax |
|
| Email |
saritakamate9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Late Kedari Redekar Ayurvedic College, Hospital and Research centre, P-2, MIDC, Shendri Mal, Gadhinglaj -416502, District- Kolhapur |
|
|
Primary Sponsor
|
| Name |
Dr. Ravina Shinde |
| Address |
House no.-1291, St. No.-3, Noorwala Road, Anand puri Colony, Ludhiana, Punjab - 141007 |
| Type of Sponsor |
Other [Self] |
|
|
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 Ravina Shinde |
Late Kedari Redekar Ayurvedic Hospital And Research Centre |
Stree Roga Evum Prasuti Tantra OPD No. 5 and IPD, Ground floor, Late Kedari Redekar Ayurvedic College, Hospital And Research Centre, P-2, MIDC, Shendri Mal, Gadhinglaj-416502, Distric-Kolhapur, Maharashtra
Kolhapur
MAHARASHTRA |
9423840161
raveshinde10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Late Kedari Redekar Ayurvedic Hospital And Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B373||Candidiasis of vulva and vagina. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kasisadi Varti, Reference: Ashtang Hrudaya, Route: Vaginal, Dosage Form: Varti/ Suppository, Dose: 6(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Pippalyadi Varti, Reference: Charak Samhita, Route: Vaginal, Dosage Form: Varti/ Suppository, Dose: 6(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, 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 |
Patient having Clinical features like Strava, Kandu, Alpavedana Yoni, Strava Ganda, Kati Shool. |
|
| ExclusionCriteria |
| Details |
Chronic candida vaginitis(more than 6 month)
Patient with intrauterine contraceptive device and ring pessaries
Pregnancy, lactating and unmarried patient.
Known case of menorrhagia and DUB |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study efficacy of Kasisadi varti and Pippalyadi varti in management of Kaphaja Ypnivyapad w.s.r.to Candida Vaginitis |
7 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To study efficacy of Kasisadi varti in management of Kaphaja Ypnivyapad w.s.r.to Candida Vaginitis
2)To compare efficacy of Kasisadi varti and Pippalyadi varti in management of Kaphaja Ypnivyapad w.s.r.to Candida Vaginitis |
7 Days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
23/07/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Title- Randomised Controlled Clinical Trial To Evaluate Efficacy Of Kasisadi Varti And Pippalyadi Varti In The Management Of Kaphaj Yonivyapada With Special Reference To Vaginal Candidiasis,
Objective- To Study The Efficacy of Kasisadi Varti in the Management of Kaphaj Yonivyapad with special reference to Vaginal Candidiasis.
Randomised Comparative Clinical Study Study will be conducted on 80 Diagnosed patients of Kaphaj yonivyapad Written consent of patient will be taken Selected patient will be randomly distributed in two groups 40 patient each group. Groups will be named as Group A and Group B Group A - Drug- Kasisadi varti Group B - Drug- Pippalyadi varti Route of Administration- Per Vaginally Duration- 7 days Time-1-2 hours Kala- Morning Follow up- 0th, 3rd, 7th day
Statistical analysis using appropriate statistical test Discussion |