FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/08/045097 [Registered on: 30/08/2022] Trial Registered Prospectively
Last Modified On: 23/08/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Other 
Public Title of Study   To evaluate effect of Guduchyadi Kwath Yoni Prakshalan (Vaginal Douching) in the treatment of vaginitis 
Scientific Title of Study   A Clinical Study of Guduchyadi Kwath Yoni Prakshalan in the Management of Vaginitis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Santosh Vishnoi 
Designation  PG Scholar 
Affiliation  University Post Graduate Institute of Ayurved Studies and Research,jodhpur ,Rajasthan 
Address  P.G Department of Prasuti Tantra evam Stri Roga, University Post Graduate Institute of Ayurved Studies and Research, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur, Rajasthan

Jodhpur
RAJASTHAN
342037
India 
Phone  8952052073  
Fax    
Email  santoshbishnoi0025@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr A Neelima 
Designation  Professor & HOD  
Affiliation  University Post Graduate Institute of Ayurved Studies and Research,jodhpur ,Rajasthan 
Address  P.G Department of Prasuti Tantra evam Stri Roga, University Post Graduate Institute of Ayurved Studies and Research, Dr.Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur, Rajasthan

Jodhpur
RAJASTHAN
342037
India 
Phone  9610350131  
Fax    
Email  aspneelima@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Meeta Jhala  
Designation  Assistant Professor  
Affiliation  University Post Graduate Institute of Ayurved Studies and Research,jodhpur ,Rajasthan 
Address  P.G Department of Prasuti Tantra evam Stri Roga, University Post Graduate Institute of Ayurved Studies and Research, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur, Rajasthan

Jodhpur
RAJASTHAN
342037
India 
Phone  8107415431  
Fax    
Email  meetajiten6978@gmail.com  
 
Source of Monetary or Material Support  
University Post Graduate Institute of Ayurved Studies and Research Jodhpur, Rajasthan 
 
Primary Sponsor  
Name  University Post Graduate Institute of Ayurved Studies and Research Jodhpur Rajasthan 
Address  University Post Graduate Institute of Ayurved Studies and Research, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur Rajasthan 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Dr Santosh Vishnoi  P.G Department of Prasuti Tantra evam Stri Roga, University Post Graduate Institute of Ayurved Studies and Research, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur Rajasthan 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Santosh Vishnoi  University Post Graduate Institute of Ayurved Studies and Research  P.G Department of Prasuti Tantra evam Stri Roga(OPD NO-5) University Post Graduate Institute of Ayurved Studies and Research, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur, Rajasthan 342037
Jodhpur
RAJASTHAN 		 8952052073

santoshbishnoi0025@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee University Post Graduate Institute of Ayurved Studies and Research  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: charak chikitsha 30/57, Procedure details: Patient kept in lithotomy position .After that Cuscos Speculum is inserted into the vagina & vaginal douching will be done with 1liter of Guduchyadi Kwath Twice in a day.)
(1) Medicine Name: Guduchyadi Kwath , Reference: charak chikitsha 30/57, Route: Vaginal, Dosage Form: Kwatha/Kashaya, Dose: 1000(ml), Frequency: bd, Duration: 7 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1.Married women
2.Patients suffering from any of the two following sign and symptoms Vaginal pain,Vaginal discharge,Vulval itching / vaginal irritation,Burning micturition
3.Painful intercourse due to vaginitis.
 
 
ExclusionCriteria 
Details  1.Pregnant women
2.Unmarried women
3.Patient have positive HbsAg , HIV , VDRL
4.Hypersensitivity to drug and inability to confine to protocol
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in the Vaginal Itching, Burning Micturition, Vaginal discharge,Inflammation, Tenderness   60 Days 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in Dyspareunia, Fever.   60 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   01/09/2022 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   no 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Vaginitis is a common complaint in women, accounting for 7% of all visits to gynecologist and being the most common gynecologic problem encountered by primary care providers for women.Vaginitis is the inflammation of the vagina characterized by abnormal vaginal discharge, itching, burning and pain.Noninfectious causes including atrophic, irritant, allergic, and inflammatory vaginitis are less common and account for 5% to 10% of vaginitis cases.The acidic environment of vagina created by naturally occurring bacteria in the normal vaginal flora prevents infection.The most common causes of vaginitis are bacterial vaginosis, vulvovaginal candidiasis and trichomoniasis. Bacterial vaginosis is implicated in 40% to 50% of cases when a cause is identified with vulvovaginal candidiasis accounting for 20% to 25% and trichomoniasis for 15% to 20% of cases.Vaginitis is a common medical problem in women that is associated with substantial discomfort and frequent medical visits. Roughly 5 to 10 million office visits per year are attributed to vaginitis.

Guduchyadi KwathaYoni Prakshalana will be selected for this study given in Charak Chikitsa Yonivyapad Guduchyadi Kwatha (Guduchi, Triphala, Danti),the drug Guduchi has Tikta Kashaya Rasa, Guru Snigdha Guna,Ushna Veerya,Madhura Vipaka and having properties like Tridoshaara, Balya, Stambhana, Kandughna, Yonisodhana, Vedanasthapana, Shothahara, Dahaprashamana, Vranashodana, and Vranaropana. The drug Danti has Katu Rasa, Guru, Tikshnaguna, Ushnavirya, Katuvipaka, Kaphavatahara, property. The drugs in Triphala has Tridoshahara, Rasayanam, Bhedana, Anulomana property. Stambhanaproperty of Guduchyadi Kwathayoni Prakshalana helps to reduce Yonisrava (Vaginal discharge). Due to Ushnaveerya of drugs pacifies Vata Dosha and relive Yoni Toda (vaginal pain). Due to Krimi or Jantughnaproperty of drugs, relive Yonikandu.

 
Close