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CTRI Number  CTRI/2025/10/095814 [Registered on: 09/10/2025] Trial Registered Prospectively
Last Modified On: 01/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effect of Shatavaryadi Ghrita in Asrigdara (menorrhagia). 
Scientific Title of Study   An Open Label Single Arm Clinical Study to Evaluate The Efficacy of Shatavaryadi Ghrita in Asrigdara w.s.r. 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 Shivangi Yadav 
Designation  PG Scholar 
Affiliation  Shri Babu Singh Jay Singh Ayurvedic Medical College and Hospital  
Address  Shri Babu Singh Jay Singh Ayurvedic Medical College and Hospital Bhaupur Farrukhabad UP

Farrukhabad
UTTAR PRADESH
209602
India 
Phone  7881166826  
Fax    
Email  yadavshivangi1710@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ramu G 
Designation  Professor and HOD 
Affiliation  Shri Babu Singh Jay Singh Ayurvedic Medical College and Hospital 
Address  Shri Babu Singh Jay Singh Ayurvedic Medical College and Hospital Bhaupur Farrukhabad UP

Farrukhabad
UTTAR PRADESH
209602
India 
Phone  7652080752  
Fax    
Email  ayurlord@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shivangi Yadav 
Designation  PG scholar 
Affiliation  Shri Babu Singh Jay Singh Ayurvedic Medical College and Hospital  
Address  Shri Babu Singh Jay Singh Ayurvedic Medical College and Hospital Bhaupur Farrukhabad UP

Farrukhabad
UTTAR PRADESH
209602
India 
Phone  7881166826  
Fax    
Email  yadavshivangi1710@gmail.com  
 
Source of Monetary or Material Support  
Shri Babu Singh Jay Singh Ayurvedic Medical College and Hospital Bhaupur Farrukhabad 209625 Uttarpradesh India 
 
Primary Sponsor  
Name  Dr Shivangi Yadav 
Address  Shri Babu Singh Jay Singh Ayurvedic Medical College and Hospital Bhaupur Farrukhabad 209625 UttarPradesh India 
Type of Sponsor  Other [Self] 
 
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 Shivangi Yadav  Shri Babu Singh Jay Singh Ayurvedic Medical College and Hospital   Room no 2 Room no 310, division no 1 department of Stree Rog Prasuti tantra 2nd floor Bhaupur, Bewar Road, Farrukhabad 209625 Uttar Pradesh
Farrukhabad
UTTAR PRADESH 		 07881166826

yadavshivangi1710@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Shri babu singh jay singh ayurvedic medical college   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. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH, (2) ICD-10 Condition:R688||Other general symptoms and signs. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Shatavaryadi Ghrita, Reference: Shusruta Samhita, Route: Oral, Dosage Form: Ghrita, Dose: 20(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: Half an hour before food twice daily
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Patient presenting with excessive, prolonged menstrual bleeding, intermenstrual bleeding for 2 months
irrespective of parity
married female
complaint of menorhagia from 3 cycles or more than 3 cycle 
 
ExclusionCriteria 
Details  unmarried
below 18 and above 45 yrs of age
on going research study
recent abortion, anemia, tb, hypertension, dm, hypo or hyperthyroidism, cardiac disease, renal parynchymal disease, jaundice,
benign or malignant growth, cervical errosion, cervical polyp, pid, pterovaginal prolapse, endometriosis, h/o IUD 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Efficacy of Shatavaryadi Ghruta in asrugdara could me more as compared to any other drug.   The effect can be seen in 4 to 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
ALONG WITH ASRIGDARA IMPROVEMENT OF OTHER YONIVYAPAD MAY IMPROVE  3 MONTHS 
 
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)   01/01/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/01/2026 
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 Yet Recruiting 
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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  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 - To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (shivi1710@gmail.com).

  6. For how long will this data be available start date provided 12-06-2025 and end date provided 12-06-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Now a days due to change in lifestyle menstrual issues are the major problems faced by females. Soo as per the OPD prevalence it was observed that asrigdara found to be observed very frequent disease in females of age 18 to 45 yrs married female with no comorbidities Shatavaryadi ghruta in 30 patients was planned to give as per diagnostic, inclusion and exclusion criteria as an open lable single arm clinical study to evaluate the efficasy of Shatavaryadi ghrita in Asrugdara. 
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