| CTRI Number |
CTRI/2025/08/093080 [Registered on: 14/08/2025] Trial Registered Prospectively |
| Last Modified On: |
13/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
EFFECT OF SAHACHAR, NIMB, PATHA, PATOL KWATH YONI DHAWAN IN KAPHAJ YONI VYAPAD. |
|
Scientific Title of Study
|
"RANDOMIZED CONTROLLED CLINICAL TRIAL TP STUDY THE EFFICACY OF SAHACHAR, NIMB, PATHA, PATOL KWATH YONIDHAWAN IN THE MANAGEMENT OF KAPHAJ YONIVYAPAD" |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shubhangi Gajanan Mulange |
| Designation |
PG Scholar |
| Affiliation |
Ayurvedic Medical College and Hospital PG Institue And Reserch Center Uran Islampur Sangli |
| Address |
LRP Ayurvedic Medical College and Hospital PG Institue And Reserch Center Uran Islampur Sangli
OPD No 5 Prasutitantra And Streerog Department LRP Ayurvedic Medical College and Hospital PG Institue And Reserch Center Uran Islampur Sangli, Maharashtra 415409.
Sangli
MAHARASHTRA
415409
India |
| Phone |
7249339564 |
| Fax |
|
| Email |
shubhangimulange09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sachin Jagannath Patil |
| Designation |
Professor |
| Affiliation |
Ayurvedic Medical College and Hospital PG Institue And Reserch Center Uran Islampur Sangli |
| Address |
LRP Ayurvedic Medical College and Hospital PG Institue And Reserch Center Uran Islampur Sangli
OPD No 5 Prasutitantra And Streerog Department LRP Ayurvedic Medical College and Hospital PG Institue And Reserch Center Uran Islampur Sangli, Maharashtra 415409.
Sangli
MAHARASHTRA
415409
India |
| Phone |
9422407301 |
| Fax |
|
| Email |
Sachinpatil5190@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sachin Jagannath Patil |
| Designation |
Professor |
| Affiliation |
Ayurvedic Medical College and Hospital PG Institue And Reserch Center Uran Islampur Sangli |
| Address |
LRP Ayurvedic Medical College and Hospital PG Institue And Reserch Center Uran Islampur Sangli
OPD No 5 Prasutitantra And Streerog Department LRP Ayurvedic Medical College and Hospital PG Institue And Reserch Center Uran Islampur Sangli, Maharashtra 415409.
Sangli
MAHARASHTRA
415409
India |
| Phone |
9422407301 |
| Fax |
|
| Email |
Sachinpatil5190@gmail.com |
|
|
Source of Monetary or Material Support
|
| Loknete Rajarambapu Patil Ayurvedic Medical College and Hospital PG Institute And Research Centre Urun Islampur Sangli Maharashtra India 415409. |
|
|
Primary Sponsor
|
| Name |
DrShubhangi Gajanan Mulange |
| Address |
Loknete Rajarambapu Patil Ayurvedic Medical College and Hospital PG Institute And Reserch Center Urun Islampur Sangli Maharashtra India 415409 |
| 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 Shubhangi Gajanan Mulange |
LRP Ayurvedic Medical College and Hospital PG Institue And Reserch Center Uran Islampur Sangli |
OPD No 5 Department Of Streerog And Prasutitantra LRP Ayurvedic Medical College And Research Institute Urun Islampur Sangli Maharashtra
Sangli
MAHARASHTRA |
7249339564
shubhangimulange09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee LRP Ayurvedic Medical College and Hospital and PTC and RC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:1||Obstetrics. 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: SAHACHAR NIMB PATHA PATOL KWATH, Reference: ASHTANG HRUDAYA UTTARTANTRA, Route: Vaginal, Dosage Form: Kwatha/ Kashaya, Dose: 1000(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -7 DAYS FOR 1 CYCLE | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: TRIPHALA KWATH, Reference: ASHTANG SANGRAHA UTTARTANTRA, Route: Vaginal, Dosage Form: Kwatha/ Kashaya, Dose: 1000(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -7 DAYS FOR 1 CYCLE |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Married women of Age between 20-45 Years
2. Shweta strav
3. Kandu
4. Alpavedana |
|
| ExclusionCriteria |
| Details |
1. Pregnant Women
2. Patients with Diabetes, Sexually Transmitted Disease, HIV,
Gonorrhea, malignancies, Carcinoma of cervix, Pelvic
Inflammatory Disease, IUCD, patient on
3. Patient not willing to give informed consent
4. Unexplained vaginal bleeding — occasionally and
intermitted. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decreased In Yonigat Strava, Yonigat Kandu, Yonigat Vedana. |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Significant Decreased In Signs and Symptoms Yonigat Strava, Yonigat Kandu, Yonigat Vedana. |
1 month |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
24/08/2025 |
| 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
|
Need has always been felt to develop certain Ayurvedic treatment modalities for the management of Kaphaj Yonivyapad and vaginal candidiasis which could be safe, effective, readily available, cost effective, without any side effects in comparison to the therapeutic procedures of different systems of medicine. There is Need to maintain womens health for this Sahachara, Nimb, Patha, Patol kwath are used they have properties like Kaphashamak, Kandughana, Krimighana, Stambhak, Vranaropak, Antiseptic. Because of these properties it helps to overcome the symptoms of Kaphaj Yonivyapad it may increase local immunity there by prevent recurrence of symptoms in patients. In other pathy drug generally have minor, major side effect it may be due to prolong use of that drug but, in ayurvedic formulation has minimum side effects. hence selection of appropriate treatment without disturbing other systems are used. |