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CTRI Number  CTRI/2024/11/076564 [Registered on: 11/11/2024] Trial Registered Prospectively
Last Modified On: 06/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   EFFECT OF SHUNTHYADI CHURNA AND SHATAVARI TAILA MATRA BASTI ON HEAVY MENSUS 
Scientific Title of Study   A CLINICAL STUDY TO EVALUATE THE EFFICACY OF SHUNTHYADI CHURNA AND SHATAVARI TAILA MATRA BASTI ON ASRIGDARA W.S.R TO DYSFUNCTIONAL UTERINE BLEEDING 
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 Jyoti Meena 
Designation  PG Scholar 
Affiliation  Madan Mohan Malviya Govt. Ayurved College Udaipur 
Address  P.G. Department of Prasuti Tantra Evum Striroga Madan Mohan Malviya Govt. Ayurved College Ambamata Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  7073825646  
Fax    
Email  Jyotimeena1706@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Narendra Kumar Meena 
Designation  Associate Professor & HOD And Guide 
Affiliation  Madan Mohan Malviya Govt. Ayurved College Udaipur 
Address  P.G. Department of Prasuti Tantra Evum Striroga Madan Mohan Malviya Govt. Ayurved College Ambamata Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  9950129673  
Fax    
Email  NARENDERMEENA42@YAHOO.COM  
 
Details of Contact Person
Public Query  
Name  Dr Narendra Kumar Meena 
Designation  Associate Professor & HOD And Guide 
Affiliation  Madan Mohan Malviya Govt. Ayurved College Udaipur 
Address  P.G. Department of Prasuti Tantra Evum Striroga Madan Mohan Malviya Govt. Ayurved College Ambamata Udaipur


RAJASTHAN
313001
India 
Phone  9950129673  
Fax    
Email  NARENDERMEENA42@YAHOO.COM  
 
Source of Monetary or Material Support  
Madan Mohan Malviya Govt. Ayurved College Udaipur,313001,Rajasthan India 
 
Primary Sponsor  
Name  Madan Mohan Malviya Govt. Ayurved College Udaipur 
Address  Madan Mohan Malviya Govt. Ayurved College Udaipur,313001,Rajasthan India 
Type of Sponsor  Government medical college 
 
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 Jyoti Meena  Madan Mohan Malviya Govt. Ayurved College,Udaipur  O.P.D. No.-5 , Prasuti Tantra Evum Striroga Department ,Udaipur , Rajasthan
Udaipur
RAJASTHAN 		 7073825646

Jyotimeena1706@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, Madan Mohan Malviya Govt. Ayurved College  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. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Shunthyadi Churna, Reference: Yogratnakara Pradara Roga Chikitsa 18, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Ghrit & Sharkara), Additional Information:
2Comparator ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: Charaka Siddhi Sthana, Procedure details: Matra basti with Shatavari taila 60 ml will be given by rectal route for 5 days (follicular phase) of 3 consecutive menstrual cycles.)
(1) Medicine Name: Shatavari taila, Reference: Sharangdhara Samhita Madhyam khand , Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 3 Months
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. Patients willing for the trial.
2.⁠ ⁠Patients between the age group of 15- 45 years.
3.⁠ ⁠Patients having symptoms of Asrigdara (DUB). 
 
ExclusionCriteria 
Details  1. Patients of age group below l5years and above 45years.
2.⁠ ⁠Patients with uterine and pelvic pathology like Big Fibroid,
Ca Cervix, Cervical Polyps, Endometrial carcinoma etc.
3.⁠ ⁠Bleeding due to coagulation disorders.
4. Patient having bleeding due to abortions. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in the signs and symptoms after treatment .  12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in other associated symptoms  12 weeks 
 
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 
Date of First Enrollment (India)   15/12/2024 
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="0"
Months="3"
Days="0" 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response (Others) - 
  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 15-11-2024 and end date provided 30-04-2025?
    Response (Others) - 

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   This study is about to evaluate the efficacy of Shunthyadi Churna and Shatavari Taila Matra Basti on Asrigdara w.s.r. to Dysfunctional Uterine Bleeding .
There will be a single group of 30 patients.
Patients will be treated with Shunthyadi churna 3 gm BD with Ghrit  and Shatavari Taila Matra Basti 60 ml (per rectum) in follicular phase for 5 days for 3 consecutive menstrual cycle.
The trial will be carried out for 3 months .
 
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