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CTRI Number  CTRI/2025/02/080945 [Registered on: 20/02/2025] Trial Registered Prospectively
Last Modified On: 13/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Vaginal wash with medicated decoction in white discharge in pregnancy 
Scientific Title of Study   Randomized Comparative Clinical Trial Of The Efficacy Of Yonidhavan With Guduchyadi Kwath And Panchavalkal Kwath In The Management Of Upapluta Yonivyapad W.S.R. 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 Shraddha Bhaskar Mate 
Designation  MS Prasutitantra Evam Streerog Scholar 
Affiliation  Matoshree Asarabai Darade Ayurved College Babhulgaon, Yeola 
Address  OPD No 8 Department Of Prasutitantra Evum Striroga, Matoshree Asarabai Darade Ayurved College Babhulgoan, Tal-Yeola Dist-Nashik Pin-423401 Maharashtra India

Nashik
MAHARASHTRA
423401
India 
Phone  09511629660  
Fax    
Email  missshraddhamate@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Limbanappa Garthe 
Designation  Professor PG Guide Prasutitantra evum Streerog Department 
Affiliation  Matoshree Asarabai Darade Ayurved College Babhulgoan ,Yeola 
Address  OPD No.8 Department of Prasutitantra evum Streerog Matoshree Asarabai Darade Ayurved College Babhulgoan Tal- yeola Dist-Nashik Pin-423401 Maharashtra India

Nashik
MAHARASHTRA
423401
India 
Phone  9822315561  
Fax    
Email  lsgarthe@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shraddha Bhaskar Mate 
Designation  MS Prasutitantra Evum Streerog Department Scholar 
Affiliation  Matoshree Asarabai Darade Ayurved College Babhulgoan ,Yeola 
Address  OPD No.8 Department of Prasutitantra evum Streerog Matoshree Asarabai Darade Ayurved College Babhulgoan Tal- yeola Dist-Nashik Pin-423401 Maharashtra India

Nashik
MAHARASHTRA
423401
India 
Phone  9511629660  
Fax    
Email  missshraddhamate@gmail.com  
 
Source of Monetary or Material Support  
Department of Prasutitantra Evum Streerog, Matoshree Asarabai Darade Ayurved College Babhulgaon, Yeola Tal- Yeola, Dist- Nashik ,State_ Maharashtra, India Pincode-423401 
 
Primary Sponsor  
Name  Matoshree Asarabai Darade ayurved College Babhulgaon, Yeola 
Address  Matoshree Asarabai Darade ayurved College Babhulgaon, Tal-Yeola Dist- Nashik Maharashtra India Pin-423401 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shraddha Mate  Matoshree Asarabai Darade Ayurved College Babhulgaon, Yeola  OPD no.8 Department Of Prasutitantra Evum Streeroga
Nashik
MAHARASHTRA 		 09511629660

missshraddhamate@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Matoshree Asarabai Ayurved College Babhulgaon Yeola  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-yoni dhavana योनि धावन (Procedure Reference: Ashtanghruday guhyarogpratishedhadhyay, Procedure details: Purvakarma Patient taken in dorsal position Vajina cleaned with cotton swab soaked with normal saline Pradhan karma A rubber catheter connected to enema pot filled with Guducchyadi kwath Another end inserted in vagina yonidhavan done slowly Pashchatkarma Ask patient to lie down for 15 minutes)
(1) Medicine Name: Guducchyadi kwath, Reference: Ashtang hruday guhyarogpratishedhadhyay , Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 500(ml), Frequency: od, Duration: 7 Days
2Comparator ArmProcedure-yoni dhavana योनि धावन (Procedure Reference: Sushrutsamhita Uttartantra Yonivyapadpratishedhadhyay, Procedure details: Purvakarma Patient taken in dorsal position Vajina cleaned with cotton swab soaked with normal saline Pradhan karma A rubber catheter connected to enema pot filled with Panchavalkal kwath Another end inserted in vagina yonidhavan done slowly Pashchatkarma Ask patient to lie down for 15 minutes)
(1) Medicine Name: Panchavalkal kwath, Reference: Sushrutasamhita Uttartantra Yonivyapadpratishedhadhyay, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 500(ml), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Indoor and outdoor Patient having classical symptoms of upapluta
yonivyapad i.e. vaginal candidiasis
Diagnosed case Gestational Diabetis
 
 
ExclusionCriteria 
Details  Non pregnant
1st trimester pregnancy upto 12 weeks of GA
full term pregnancy, after 36 weeks of GA
sexually transmitted diseases HIV HBsAg VDRL
previously taken allopathy treatment for vaginal candidiasis within 15 days
womens have vaginal infections other than vaginal candidiasis
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Yonigat Shwetastrav
Yonikandu
Lower abdominal pain
Burning Micturation
Backache
Foul smell
All above symptoms will be decreased 		 1st day
2nd day
3rd day
4th day
5th day
6th day
7th day 
 
Secondary Outcome  
Outcome  TimePoints 
Decreased symptoms completely  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   N/A 
Date of First Enrollment (India)   24/02/2025 
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="1" 
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                      In pregnancy there is altered immunological state is which women is prone for many diseases metabolic as well as infective origin In women vaginal secretion are under the influence of hormonal changes vaginal flora which contains aerobic and anaerobic microorganism responsible for maintaining pH This pH has defense mechanism against microorganism growth in female genital track Pregnant state produces several normal and expected changes in all the maternal organ systems from which vaginal candidiasis is one Vaginal pH changes during pregnancy Mainly vaginal pH change during pregnancy  falls from a pH of greater than seven alkaline to four or five  acidic Due to this change in vaginal pH and candida albicans growth occurs
                    In pregnancy there is high estrogen level and higher glycogen level which helps in growth of candida  Responsible conditions GDM obesity unhygienic conditions are responsible surgical procedure like cervical cerclage also causes vaginal infection foreign body reaction According to ayurveda if women during pregnancy take kapha aggravating Ahar and vihar excessively and suppresses the urge of vomiting and respiration the vitiated vayu carries kapha to genital tract affect the same and vaginal white discharge is seen in pregnant women  due to kapha and vata this is known as upapluta yonivyapad  Modern science also has good treatment for vaginal candidiasis local and oral. But its safety in pregnancy is doubtful are little expensive as well as they do not prevent recurrence In addition vaginitis may occur as the result of noninfectious causes Such as vaginal atrophy allergies and chemical irritation It is accepted by everyone that ayurveda is an ancient most treatise in medical world in samhitas there is description of yonivyapad from which upapluta yonivyapad is one described by acharyas on the basis of the textual description upapluta yonivyapad can be compared to candidiasis during pregnancy.
Prevalence rate of vaginal candidiasis in pregnant women in India is thirty percent 
PURPOSE OF STUDY 
Microbial infections of the vagina among pregnant women are serious issues and may lead to many medical emergencies such as preterm labor amniotic fluid infection premature rupture of fetal membranes and low birth weight of neonate Pregnant women have twofold increase in the prevalence of vaginal micro organisms  colonization than compared to nonpregnant women Increased levels of circulating estrogens and deposition of glycogen and other substrates in vagina during pregnancy influences the association Thus there is need of proper identification and find out an effective curating safe harmless treatment which will reduce the risk of preterm birth and its consequences Although modern science also have limitations for treatment due to contraindications of many effective drugs in pregnancy As ayurvedic medicines are act by causing samprapti bhanga having less side effects and less harmful to pregnancy and minimum chance of recurrence it can be proved much effective As yoni having secretary action which makes the mucosa more absorbable local application of decoration can be used It can affects vaginal pH by its rasa absorbs by mucosa  consequently blood and may act as antiseptic bactericidal analgesic anti inflammatory and also may prevents growth of microbes
 
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