| CTRI Number |
CTRI/2024/01/061868 [Registered on: 25/01/2024] Trial Registered Prospectively |
| Last Modified On: |
21/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Sarvatobhadradi kashaya yoni dhavan and yoni pichu for white discharge per vagina patients |
|
Scientific Title of Study
|
A clinical study of sarvatobhadradi kashaya yoni prakshalana and sarvatobhadradi taila yoni pichu in the management of shwet pradara
|
| 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. PRATIBHA DEVI |
| Designation |
PG Scholar |
| Affiliation |
Government pg ayurvedic medical college and hospital varanasi |
| Address |
Government pg ayurvedic medical college and hospital varanasi
Department of prasuti tantra evum stree roga
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
8896706408 |
| Fax |
|
| Email |
pratibhar25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Shashi singh |
| Designation |
Professor |
| Affiliation |
Government pg ayurvedic medical college and hospital varanasi |
| Address |
Department of prasuti tantra evum stree roga government pg ayurvedic medical college and hospital varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
7652022452 |
| Fax |
|
| Email |
shashi.aymc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Shashi Singh |
| Designation |
Professor |
| Affiliation |
Government pg ayurvedic medical college and hospital varanasi |
| Address |
Department Of Prasuti tantra Evum Stree Roga Government Pg Ayurvedic Medical College And Hospital Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
7652022452 |
| Fax |
|
| Email |
shashi.aymc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government ayurvedic pg college and hospital varanasi
|
|
|
Primary Sponsor
|
| Name |
Government pg ayurvedic medical college and hospital varanasi |
| Address |
Department of prasuti tantra evum stree roga government pg ayurvedic medical college and hospital varanasi
|
| Type of Sponsor |
Government 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 Pratibha Devi |
Government pg ayurvedic medical college and hospital varanasi |
Department of prasuti tantra evum stree roga government pg ayurvedic medical college and hospital varanasi
Varanasi
UTTAR PRADESH |
8896706408
pratibhar25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Ayurvedic College And Hospital Varanasi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N768||Other specified inflammation of vagina and vulva. Ayurveda Condition: SOMAROGAH/SVETAPRADARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Sarvtobhadradi kashaya , Reference: NA, Route: Vaginal, Dosage Form: Kwatha/Kashaya, Dose: 400(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 8 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Age- 21-45 year married females
Patients complaining of white discharges P/V
Patients having vaginal infections like candida albicans and bacterial vaginosis
Associated symptoms like vaginal irritaion vulval/vaginal itching, low backache and general weakness. |
|
| ExclusionCriteria |
| Details |
Pregnant females
women below 21years and more than 45yrs
Unmarried women
Taking ocp and having IUCD inserted
any systemic illness like DM,HTN,Thyroid disorder,Chronic infections |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in white discharge per vaginally of the patients |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in the status of white discharge per vaginum
its consistency
lower backache
vaginal pH
yoni kandu
Foul smell |
90 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "57"
Final Enrollment numbers achieved (India)="57" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
04/02/2024 |
| Date of Study Completion (India) |
31/07/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="7" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
CLINICAL EVALUATION OF
SARVATOBHADRADI KWATH YONI
PRAKSHALANA AND SARVATOBHADRADI
TAILA YONI PICHU IN SHWETA PARADARA published in International Journal of Research and Analytical Reviews August 2024, Volume 11 Issue 3 E-ISSN: 2348-1269, P-ISSN: 2349-5138 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
A Clinical Study Of Sarvatobhadradi Kashaya Yoni Prakshalana and Sarvatobhadradi Tail yoni pichu in the Management Of Shweta Pradara Total 60 patients aged between 21 and 45 years.
Result
In trial group (Sarvatobhadradi Kashaya & Sarvatobhadradi Taila), statistically highly significant results were found in yoni srava (79.82%), consistency of srava (95.73%), kati shool (92.41%), vibandha (88.77%), yoni kandu (88.64%), yoni Vedana (100%), vaginal pH (74.72%), The overall effect of therapy shows that 61.40% patients were having maximum improvement (relief more than 75%), 28.07% patients were having moderate improvement (>50%-75% relief), and 10.53% patients were having mild improvement (>25%-50% relief) |