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CTRI Number  CTRI/2024/03/064926 [Registered on: 28/03/2024] Trial Registered Prospectively
Last Modified On: 19/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Diagnostic 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A Clinical And Experimental Study Of Vaginal Douching And Vaginal Tampon With Indigenous Drugs In Management Of Abnormal Vaginal Discharge 
Scientific Title of Study   A Clinical And Experimental Study Of Yoni Dhawan And Yoni Puran With Indigenous Drugs In Management Of SHWETA PRADAR(Abnormal Vaginal Discharge) 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Seema Shukla 
Designation  Head of department, Prasuti Tantra evum Stree Roga 
Affiliation  Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Distt Kangra HP 
Address  Department of PTSR, Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Distt Kangra HP

Kangra
HIMACHAL PRADESH
176115
India 
Phone  941808833  
Fax    
Email  drseemanil@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Seema Shukla 
Designation  Head of department, Prasuti Tantra evum Stree Roga 
Affiliation  Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Distt Kangra HP 
Address  Dept of PTSR, Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Distt Kangra HP

Kangra
HIMACHAL PRADESH
176115
India 
Phone  941808833  
Fax    
Email  drseemanil@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Suman Kumari 
Designation  PG Scholar , Prasuti Tantra evum Stree Roga 
Affiliation  Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Distt Kangra HP 
Address  Dept of PTSR, Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Distt Kangra HP

Kangra
HIMACHAL PRADESH
176115
India 
Phone  8894235919  
Fax    
Email  dr.sumandhiman@gmail.com  
 
Source of Monetary or Material Support  
Charak pharmacy, Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Distt Kangra ,HP, Reasearch Institute in ISM Jogindernagar, Distt Mandi HP 
 
Primary Sponsor  
Name  Dr Vijay Chaudhary Principal 
Address  Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Distt Kangra HP 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
HOD Dept of Prasuti Tantra evum Stree Roga  RGGPG Ayurvedic College and Hospital Paprola Distt Kangra HP 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Seema Shukla  Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Distt Kangra HP  OPD and IPD of Department Of Prasuti Tantra evum Stree Roga,RGGPG Ayurvedic College and Hospital Paprola Distt Kangra HP
Kangra
HIMACHAL PRADESH 		 941008833

drseemanil@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (Human), RGGPG Ayurvedic College and Hospital Paprola Distt Kangra HP  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N761||Subacute and chronic vaginitis. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-yoni dhAvana, योनि धावन (Procedure Reference: yonivyapada chikitsa, Procedure details: Yoni dhawan with Kwath approx 500 ml once a day for 7 days arter clearance of menstruation. Duration- 7 days for 2 consecutive cycles after clearance of menstruation)
(1) Medicine Name: Anubhoota Yog (Jhabuk, Raal, Mayaphal,Rakta kankshi), Reference: B.P.Ni Haritkayadi Varga (167-168), B.P.Ni Karpooradi Varga (48-49), API -1 VOL 4 (pg. 64), R.Tr.Ekadash Trang (181, 191),, Route: Vaginal, Dosage Form: Kwatha/Kashaya, Dose: 500(ml), Frequency: od, Duration: 7 Days
2Intervention ArmProcedure-yoni pUraNa , योनि पूरण  (Procedure Reference: yonivyapada chikitsa, Procedure details: yoni puran with Kalka with approx 10 gm once a day for 7 days after clearance of menstruation. Duration 7 days for 2 consecutive cycles after clearance of menstruation.)
(1) Medicine Name: Anubhoota Yog(Jhabuk, Raal, Mayaphal, Raktakankshi), Reference: B.P.Ni Haritkayadi Varga (167-168), B.P.Ni Karpooradi Varga (48-49), API -1 VOL 4 (pg. 64), R.Tr.Ekadash Trang (181, 191), Route: Vaginal, Dosage Form: Kalka/ Paste, Dose: 10(g), Frequency: od, Duration: 7 Days
3Comparator Arm (Non Ayurveda)-Vaginal suppositriesClindamycin 100mg & Clotrimazole 100 mg for 7 days bedtime
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. Patient willing, giving consent and able to participate in the trial.
2. patient between age group of 20-40 years.
3. clinically diagnosed patients which fell under symptomatic criteria of Shweta Pradar.
4. Married female patients.  
 
ExclusionCriteria 
Details  1. Unmarried Women
2. Pregnancy
3. Age- less than 20 years & more than 40 years
4. Patient having Venereal diseases
5. genital malignancies
6. Diabetic and severely anemic
7. HIV 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Overall improvement which will be shown by the patients in P/S P/V examination & sign and symptoms.  once a day for 7 days for 2 consecutive cycles after clearance of menstruation




















 
 
Secondary Outcome  
Outcome  TimePoints 
Overall improvement which will be shown by the patients in P/S P/V examination & sign and symptoms.  once a day for 7 days for 2 consecutive cycles after clearance of menstruation

 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   15/04/2024 
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="0"
Months="3"
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   Research report will be soon published after the completion of trial 90 patients fulfilling the Inclusion and Exclusion criterias will be randomly selected from the OPD and IPD of department of Prasuti Tantra evum Stree Roga, RGGPG Ayurvedic College and Hospital Paprola Distt Kangra HP.
patient will be divided into three groups of  30  each 1. Yoni Dhawan with kwath of Anubhoota Yog  2. Yoni Puran with Kalka of Anubhoota Yoga 3. Vaginal suppository with clindamycin 100 mg & clotrimazole with 100 mg.
Duration of trial - 7 days for 2 consecutive cycles after clearance of menstruation.
Follow up - 1st follow up - after 10 days of 1st drug administration.
2nd follow up - after clearance of menstruation at next cycle (2nd menstrual cycle)
3rd follow up - after 10 days of 2nd drug administration.
Drug free period- after the clearance of 3rd menstrual cycle.

Result will be assessed on the basis of subjective and objective assessment  criterias. 
 
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