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CTRI Number  CTRI/2020/03/023744 [Registered on: 03/03/2020] Trial Registered Prospectively
Last Modified On: 27/06/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Managment of vaginal bleeding by ayurvedic medicine and procedure 
Scientific Title of Study   MANAGEMENT OF ASRIGDARA (AUB) BY VIRECHANA AND VASADI CHURNA: A RANDOMIZED COMPARATIVE CLINICAL STUDY 
Trial Acronym  AUB  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ANKIT KUMAR GARG 
Designation  RESEARCH SCHOLAR 
Affiliation  IPGT AND RA GAU JAMNAGAR 
Address  OPD NO 1 DEPARTMENT OF PRASUTI TANTRA EVAM STRI ROGA IPGT AND RA GUJRAT AYURVED UNIVERSITY JAMNAGAR
DEPARTMENT OF PRASUTI TANTRA EVAM STRI ROGA 5TH FLOR IPGT AND RA GUJRAT AYURVED UNIVERSITY OPPOSITE CITY B DIVISION POLICE STATION JAMNAGAR
Jamnagar
GUJARAT
361008
India 
Phone  8302463471  
Fax    
Email  drankitgarg111@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  PROF LAXMIPRIYA DEI 
Designation  professor 
Affiliation  IPGT AND RA GAU JAMNAGAR 
Address  5TH FLOR DEPARTMENT OF PRASUTI TANTRA EVAM STRI ROGA IPGT AND RA GUJRAT AYURVED UNIVERSITY JAMNAGAR
DEPARTMENT OF PRASUTI TANTRA EVAM STRI ROGA IPGT AND RA HOSPITAL JAMNAGAR
Jamnagar
GUJARAT
361008
India 
Phone  9106943729  
Fax    
Email  deilaxmipriya@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  PROF LAXMIPRIYA DEI 
Designation  professor 
Affiliation  IPGT AND RA GAU JAMNAGAR 
Address  DEPARTMENT OF PRASUTI TANTRA EVAM STRI ROGA 5TH FLOR IPGT AND RA GUJRAT AYURVED UNIVERSITY JAMNAGAR
DEPARTMENT OF PRASUTI TANTRA EVAM STRI ROGA 5TH FLOR IPGT AND RA GUJRAT AYURVED UNIVERSITY JAMNAGAR
Jamnagar
GUJARAT
361008
India 
Phone  9106943729  
Fax    
Email  deilaxmipriya@yahoo.com  
 
Source of Monetary or Material Support  
IPGT AND RA GAU JAMNAGAR 
 
Primary Sponsor  
Name  IPGT AND RA GAU JAMNAGAR 
Address  IPGT AND RA GAU JAMNAGAR OPPOSITE B DIVISION POLICE STATION JAMNAGAR 
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 
ANKIT KUMAR GARG  IPGT AND RA PG HOSPITAL   OPPOSITE CITY B DIVISION POLICE STATION JAMNAGAR
Jamnagar
GUJARAT 
8302463471

drankitgarg111@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N939||Abnormal uterine and vaginal bleeding, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  VIRECHANA  Group A patients will be administered Virechana drug using Trivruta Avaleha 80 to 100 gm followed by Vasadi Churna 3 gm 6 hourly during bleeding 3 gm bd after bleeding orally with Anupana of Madhu for 60 dyas 
Comparator Agent  VASADI CHURNA  Group B patients will be treated with Vasadi Churna 3 gm 6 hourly during bleeding 3 gm bd after bleeding orally with Anupana of Madhu for 60 days  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  Patients having any one or two of the following features will be included
Ayurvedic features of Asrigdara
Modern features
Excessive bleeding
Prolonged duration
Intermenstrual bleeding
Bleedinng due to other cause
Patients who are Yogya for Virechana
The quantity of bleeding will be decided by complete soaked number of pads and using thickened pads
 
 
ExclusionCriteria 
Details  Age below 18 and above 50 years
Bleeding due to Erosion cancer fibroid and Polyp
Bleeding followed by abortion
Bleeding from the site other than the uterus
Coagulation disorders
Suffering from malignancies and chronic systemic diseases like, uncontrolled hypertension (Systolic blood pressure above 180 & Diastolic blood pressure above 120mmhg) uncontrolled diabetes (above the range of 160-200 mg/dl (RBS) Veneral disease
Patients who are Ayogya for Virechana
Post menopausal bleeding
Hb% <7 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
cure of asrigdara   4 month 
 
Secondary Outcome  
Outcome  TimePoints 
Relief in bleeding as compare to previous   4 month 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   05/03/2020 
Date of Study Completion (India) 20/05/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
not yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

This was an open-labelled, comparative parallel-group study in the management of Asrigdara. In this trial total of 38 patients were enrolled, 34 patients completed the treatment, and follow-up, 4 patients were dropped out. In Group A 17 patients had been prescribed Virechana and Vasadi Churna 3 gm 6 hourly during bleeding and 3gm BD after bleeding and in Group B, 17 patients had been prescribed the Vasadi Churna 3gm 6 hourly during bleeding and 3gm BD after bleeding for 60 days. After the completion of the treatment protocol, the follow-up period was 1 month for both groups to assess the difference in the consecutive menstrual cycle. The assessment was done based on signs and symptoms i.e., Excessive Bleeding, Prolonged duration bleeding, Intermenstrual Bleeding, Bleeding with clots and associated complaints like Vedana, Angamarda, Panduta, Daurbalya, Daha, Bhrama. 

Results: In the Overall effect of therapy, percentage relief in Group A was 89.30% while in Group B it was 74.93%. In Group A 47.05% of patients got complete remission and 35.30% of patients were found to marked improvement. While 17.65% were found to moderate improvement, no patient was found Mild improvement and remained unchanged. In Group B 5.88% of patients got complete remission and 41.17% of patients found marked improvement. While 47.05% of patients got moderate improvement, 5.88% got Mild improvement and no patient remained unchanged. This data shows that Virechana with Vasadi Churna Group (Group A) is better than Vasadi Churna Group (Group B).

           So, analysing the data obtained from the present study, the null hypothesis i.e., Virechana followed by Vasadi Churna is not effective than that of Vasadi Churna alone in the management of Asrigdara (AUB)) has rejected and the alternate hypothesis i.e., Virechana followed by Vasadi Churna (Group A) is more effective than Vasadi Churna alone (Group B) in the management of Asrigdara (AUB)) has accepted.

 

 
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