FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/08/020743 [Registered on: 16/08/2019] Trial Registered Prospectively
Last Modified On: 23/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Ayurvedic management of heavy menstrual bleeding or intermenstrual bleeding by the intervention of oral medication and panchkarma therapy. 
Scientific Title of Study   Role of kutajashtaka avaleha and yashtimadhu ghrita matra basti in the management of asrigdara. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Stuti Sharma 
Designation  P G scholar 
Affiliation  All india institute of ayurveda 
Address  All india institute of ayurveda, academic block, department of stri roga and prasuti tantra, room no. 405, gautampuri, sarita vihar, mathura road, New Delhi.

South
DELHI
110076
India 
Phone  7651863828  
Fax    
Email  stuti.sharma0904@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Meenakshi pandey 
Designation  Assistant professor 
Affiliation  All india institute of ayurveda 
Address  All india institute of ayurveda, Department of stri roga and prasuti tantra, room no. 410, gautampuri, sarita vihar, mathura road, New Delhi.
Stri roga and prasuti tantra opd, All india institute of Ayurveda, gautampuri, sarita vihar, mathura road, New Delhi.
South
DELHI
110076
India 
Phone  9984549998  
Fax    
Email  drmeenakshipathak@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Stuti Sharma 
Designation  P G scholar 
Affiliation  All india institute of ayurveda 
Address  All india institute of ayurveda, academic block, department of stri roga and prasuti tantra, room no. 405, gautampuri, sarita vihar, mathura road, New Delhi.

South
DELHI
110076
India 
Phone  7651863828  
Fax    
Email  stuti.sharma0904@gmail.com  
 
Source of Monetary or Material Support  
All india institute of ayurveda, Gautampuri, sarita vihar, mathura road, New Delhi. pin- 110076 
 
Primary Sponsor  
Name  All india institute of ayurveda 
Address  All india institute of ayurveda, gautampuri, sarita vihar, mathura road, New delhi. pin-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 Stuti Sharma  All India Institute of Ayurveda  Gautampuri, sarita vihar, mathura road, New Delhi. pin- 110076
South
DELHI 		 7651863828

stuti.sharma0904@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: N921||Excessive and frequent menstruation with irregular cycle,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Kutajashtaka Avaleha  Kutajashtaka avaleha orally regularly for the period of 3 months with the doses of 5 gm twice a day after meal with water given in Group A & B. 
Comparator Agent  Yashtimadhu Ghrita matra basti  Yashtimadhu ghrita matra basti ( 60 ml for 7 days in three consecutive cycles after meal through rectal route after 7th day of menses ) for 3 months given in Group B. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  patients with symptoms of heavy and prolonged menstrual bleeding or intermenstrual bleeding.
Patients who are interested and ready to give their written consent for the study work.
patients who are willing to go for relevant investigations. 
 
ExclusionCriteria 
Details  Any diagnosed uterine organic pathology like uterine fibroid, adenomyosis, chronic tubo-ovarian mass.
systemic diseases like hypertension, diabetes mellitus, congestive cardiac failure etc.
coagulopathy, liver and thyroid dysfunction.
malignancy or undiagnosed neoplasm.
history of recent abortion.
active genital tuberculosis.
bleeding from the polyp and erosion.
IUCD in utero, pelvic endometriosis.
Hb less than 8 gm/dl.
chronic constipation. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
reduction in heavy and prolonged menstrual bleeding or intermenstrual bleeding in the cases of asrigdara.   4 months  
 
Secondary Outcome  
Outcome  TimePoints 
To assess the efficacy of drug on the change in endometrial thickness and heamoglobin level.  4 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="56" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/08/2019 
Date of Study Completion (India) 21/02/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 outcome of the study will be published in peer reviewed journal for needful. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  		 This study is a  randomised , open label, parallel group trial to evaluate the clinical efficacy of Kutajashtaka avaleha orally regularly for the period of 3 months with the doses of 5 gm twice a day after meal with water and combination of Kutajashtaka avaleha and Yashtimadhu ghrita matra basti ( 60 ml for 7 days in three consecutive cycles after meal through rectal route after 7th day of menses ) for 3 months for treating heavy and prolonged menstrual bleeding or intermenstrual bleeding in cases of asrigdara. The study will be conducted in All India Institute of Ayurveda, Sarita Vihar, New Delhi. Primary outcome of the study will be reduction in heavy and prolonged menstrual bleeding or intermenstrual bleeding in cases of Asrigdara and secondary outcome will be to assess the efficacy of drug on the change in endometrial thickness and heamoglobin level.   
Close