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CTRI Number  CTRI/2021/03/032351 [Registered on: 26/03/2021] Trial Registered Prospectively
Last Modified On: 02/05/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Clincal trial to study the effects of two drugs,hinguvadi taila yoni pichu and hinguvadi churna orally in moderate to severe mensstrual pain due to dysmenorrhea. 
Scientific Title of Study   A camparative study to evalate efficacy of Hingvadi taila Yoni Pichu and Hinguvadi Churna orally in Kashtartava w.s.r Dysmenorrhea-A randomised control clinical trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anjali Meena 
Designation  PG Scholar 
Affiliation  All India Institute of Ayurveda 
Address  Room no 4054th floor Dept. of Stri roga and Prasuti tantra Academic Block All India Istitue of Ayurveda South West Delhi

South West
DELHI
110076
India 
Phone  8802110198  
Fax    
Email  dr.anjali38@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Meenakshi Pandey 
Designation  Assistant Professor 
Affiliation  All India Institue Of Ayurveda 
Address  Room no 4054th floor Dept. of Stri roga and Prasuti tantra Academic Block All India Istitue of Ayurveda South West Delhi

South West
DELHI
110076
India 
Phone  998459998  
Fax    
Email  drmeenakshipathak@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Anjali Meena 
Designation  PG scholar  
Affiliation  All India Institue of Ayurveda 
Address  Room no 4054th floor Dept. of Stri roga and Prasuti tantra Academic Block All India Istitue of Ayurveda South West Delhi

South West
DELHI
110076
India 
Phone  8802110198   
Fax    
Email  dr.anjali38@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Ayurveda gautampuri Sarita vihar 110076 
 
Primary Sponsor  
Name  All India Institute of Ayurveda  
Address  All India Institute of Ayurveda Gautampuri Sarita vihar 110076 
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 Anjali Meena  All India Institue of Ayurveda  OPD NO.203 Hospital Block All India Institue of Ayurveda
South West
DELHI 		 8802110198

dr.anjali38@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institional Ethics Comittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E348||Other specified endocrine disorders. Ayurveda Condition: KASHTARTAVA,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Hinguvadi Churna   Hinguvadi Churna given twice a day orally with lukewarm water 7 days prior to menses for three consecutive cycles 
Intervention  Hingvadi Taila  Hingvadi Tila Yoni Pichu with 5-10 ml taila per vaginal given for 7 days prior to menses for three consecutive cycles 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Married Females in age group of 20 to 35 years
Patients coming with chief complaint of kashtatrtava with irregular menses.
Patients having scanty or average amount of menses along with associated symptoms :
 Lower abdominal pain
 Low back pain
 Nausea and vomiting
 Irregular Menses
 Diarrhoea
Patients with H/O using analgesics and other drugs during menses
Patients suffering from dysmenorrhea for more than 3 consecutive cycles.
 
 
ExclusionCriteria 
Details  Married females below 20 and above 35 years
Carcinoma of endometrium or cancer cervix
HIV ,VDRL, HBsAg positive. Patients suffering from systemic chronic illness.
Patients with H/O Endocrine dysfunction
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of hingvadi taila yoni pichu for relief in pain in kasthartava  Relief in pain after 12 week of medication 
 
Secondary Outcome  
Outcome  TimePoints 
•To Compare the effect of Hingvadi Taila Yoni Pichu and Hingvadi churna orally for relief in pain in Kasthtartava.
 		 Relief in pain. 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/04/2021 
Date of Study Completion (India) 30/04/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 24-04-2022 and end date provided 24-11-2022?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Yoni Pichu is an ancient and very result oriented Ayurvedic treatment for gynaecological complaints and a complete  solution for women’s genital ailments. Yoni Pichu has being mentioned as one of the best therapeutic procedure for alleviation of vitiated Vata.Yoni Pichu is helped in Dhaatu  strengthened,Subsidies pain,Heals the damage done to the pelvic tissues,Strengthens the vaginal muscles,Treats inflammation, erosions.

  METHODOLOGY

 

TYPE OF STUDY DESIGN- a randomised controlled trial

 

                  STATISTICAL METHOD FOR ANALYIS – Unpaired t-test

 

STUDY DESIGN- prospective

 

STUDY SETTING- All India Institute Of Ayurveda Hospital

 

STUDY POPULATION- patients suffering from dysmenorrehea

SAMPLE SIZE ESTIMATION- difference of mean standard deviation, α= 0.05 INTERVENTION GROUP- HINGVADI TAILA YONI PICHU

CONTROL GROUP – HINGVADI CHURNA Orally

 
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