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CTRI Number  CTRI/2021/09/036765 [Registered on: 23/09/2021] Trial Registered Prospectively
Last Modified On: 13/01/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare the efficacy of Shatapushpa choorna with Pishacha karpasa choorna in the management of Udavartini yonivyapada of age group 16 to 30 years. 
Scientific Title of Study   A Randomized controlled clinical trial to compare the efficacy of Shatapushpa choorna with Pishacha karpasa choorna in the management of Udavartini yonivyapada of age group 16 to 30 years. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashwini Bhausaheb Ghute 
Designation  PG Scholar 
Affiliation  PDEAs College of Ayurved and Research Center, Nigadi Pune 
Address  PDEAs College of Ayurved and Research Center, 3rd floor,Streeroga and Prasutitantra Department, Sector no. 25,Pradhikaran, Nigadi.

Pune
MAHARASHTRA
411044
India 
Phone  9767610075  
Fax    
Email  ashwinighute710@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anjali Vijay Jadhav 
Designation  H.O.D of Streeroga and Prasutitantra Department 
Affiliation  PDEAs College of Ayurved and Research Center, Nigadi Pune 
Address  PDEAs College of Ayurved and Research Center, 3rd floor,Streeroga and Prasutitantra Department, Sector no. 25,Pradhikaran, Nigadi.

Pune
MAHARASHTRA
411044
India 
Phone  9850808899  
Fax    
Email  anjalivijayjadhav@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ashwini Bhausaheb Ghute 
Designation  PG Scholar 
Affiliation  PDEAs College of Ayurved and Research Center, Nigadi Pune 
Address  PDEAs College of Ayurved and Research Center, 3rd floor,Streeroga and Prasutitantra Department, Sector no. 25,Pradhikaran, Nigadi.

Pune
MAHARASHTRA
411044
India 
Phone  9767610075  
Fax    
Email  ashwinighute710@gmail.com  
 
Source of Monetary or Material Support  
PDEAs College of Ayurved and Research Center,Sector No. 25, Pradhikaran Nigadi Pune 
 
Primary Sponsor  
Name  PDEAs College of Ayurved and Research Center Nigadi Pune 
Address  PDEAs College of Ayurved and Research Center,Sector No.25, Pradhikaran,Nigadi Pune 
Type of Sponsor  Private 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 Ashwini Bhausaheb Ghute  Ayurved Rugnalay and Sterling Multispeciality Hospital Nigadi, Pune  Streeroga and Prasutitantra OPD No. 119 ground floor, Sector 27, Pradhikaran,Nigadi.
Pune
MAHARASHTRA 		 9767610075

ashwinighute710@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:N944||Primary dysmenorrhea. Ayurveda Condition: UDAVARTINI YONI-VYAPADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Shatapushpa, Reference: Kaiyadeva Nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Koshna Jal), Additional Information:
2Comparator ArmDrugClassical(1) Medicine Name: Pishacha Karpas, Reference: Aa. Vi., Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Koshna Jal), Additional Information:
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  30.00 Year(s)
Gender  Female 
Details  patients complaining of painful menstruation foratleast 2 consecutive cycles and having regular menstrual cycle 
 
ExclusionCriteria 
Details  patient having congenital anomalies leading to dysmenorrhea and having chronic systemic diseases.
patients having pelvic pathology.
patient with iucd.
patient taking any hormonal therapy. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To Compare the efficacy of Shatapushpa choorna and Pishacha karpasa choorna in the management of Udavartini Yonivyapada  3 months with 3 followup on every monthend



















 
 
Secondary Outcome  
Outcome  TimePoints 
To study adverse effects of shatapushpa choorna if any.  3 months with 3 followup on every monthend 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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   N/A 
Date of First Enrollment (India)   25/09/2021 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
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-identiļ¬cation.

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

  3. Who will be able to view these files?
    Response - Anyone

  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 - Proposals should be directed to [ashwinighute710@gmail.com].

  6. For how long will this data be available start date provided 14-09-2023 and end date provided 14-09-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
The condition of Udavarta or Udavartini describses mainly with the primary dysmenorrhoea. On the basis of the symptom of great difficulty at the beginning of menstruation and immediate relief of pain following discharge of menstrual blood given by Charaka, is the identical symptom of primary dysmenorrhea In modern system of medicine, nonaddictive analgesics are often prescribed in the treatment of dysmenorrhea. During menstruation, many women experience gastrointestinal upsets which are increased by analgesics and antiinflammatory drugs Shatapushpa choorna is less explored yoga indicated in Yoni Vyapada. It is explained as Yoni shoola nashaka in kaiyadav nighantu. It has Vata shamaka, Vata Anulomana, & Shoolahara properties.
 
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