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CTRI Number  CTRI/2026/03/106823 [Registered on: 24/03/2026] Trial Registered Prospectively
Last Modified On: 24/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative study of Hingwadi Churna and Rajah Pravartani Vati in Kashtartava 
Scientific Title of Study   Comparative clinical evaluation of Hingwadi Churna with Rajah-Pravartani-Vati in the management of Kashtartava with special reference to Primary Dysmenorrhoea. 
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 Jaya Chaudhary 
Designation  PG SCHOLAR 
Affiliation  Chandra Shekhar Singh Ayurvedic Sansthan 
Address  OPD No. 105m Department of Prasuti Tantra evam Stri Roga

Kaushambi
UTTAR PRADESH
212213
India 
Phone  6306251439  
Fax    
Email  jayachaudhary20061993@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jaya Chaudhary 
Designation  PG SCHOLAR 
Affiliation  Chandra Shekhar Singh Ayurvedic Sansthan 
Address  OPD No. 105m Department of Prasuti Tantra evam Stri Roga


UTTAR PRADESH
212213
India 
Phone  6306251439  
Fax    
Email  jayachaudhary20061993@gmail.com  
 
Details of Contact Person
Public Query  
Name  PROF DR MAYANK KESHARWANEE  
Designation  PROFESSOR 
Affiliation  Chandra Shekhar Singh Ayurvedic Sansthan 
Address  OPD No. 105m Department of Prasuti Tantra evam Stri Roga

Kaushambi
UTTAR PRADESH
212213
India 
Phone  7376383840  
Fax    
Email  mayankkesharwani9@gmail.com  
 
Source of Monetary or Material Support  
Chandra Shekhar Singh Ayurved Chikitsalaya evam Shodh Kendra, Koilaha, Kaushambi (U.P.) 212213 India 
 
Primary Sponsor  
Name  Chandra Shekhar Singh Ayurved Chikitsalaya evam Shodh Kendra 
Address  OPD No 105, Department of Prasut evam Stri Roga 
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 Jaya Chaudhary  Chandra Shekhar Singh Ayurved Chikitsalaya  OPD No 105, Department of Prasuti Tantra evam Stri Rog
Kaushambi
UTTAR PRADESH 		 6306251439

jayachaudhary20061993@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE CSSAS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N818||Other female genital prolapse. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Hingwadi Churna, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Lukewarm water (Ushna Jala)), Additional Information: Administered for 3 consecutive menstrual cycles under supervision.
2Comparator ArmDrugClassical(1) Medicine Name: Rajah Pravartani Vati, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Lukewarm water (Ushna Jala)), Additional Information: Administered for 3 consecutive menstrual cycles for comparative evaluation.
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  30.00 Year(s)
Gender  Female 
Details  Participants coming with chief complaint of Kashtartava with scanty or average amount of
menses
Participants suffering with Kashtartava for more than 2 consecutive cycles 
 
ExclusionCriteria 
Details  Participants suffering from secondary dysmenorrhea ,STIs, systemic diseases,
Participants having organic pathology of uterus and adnexa e.g. Fibroid uterus, carcinoma of
endometrium etc,
Participants having Dysfunctional Uterine Bleeding,
Participants with H/O Thyroid dysfunction. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pain intensity assessed by Visual Analog Scale (VAS) during menstruation  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Duration of menstrual pain (in hours) during each cycle
Assessment of associated symptoms such as nausea, vomiting, fatigue, and headache
Requirement of rescue medication (if any)
Improvement in quality of life during menstruation 		 90 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   06/04/2026 
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 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 - 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 -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  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 - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [jayachaudhary20061993@gmail.com].

  6. For how long will this data be available start date provided 20-03-2026 and end date provided 19-06-2026?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NA
Brief Summary   This study aims to evaluate and compare the efficacy of Hingwadi Churna and Rajah Pravartani Vati in the management of Kashtartava (Primary Dysmenorrhea). It is a randomized, open-label, comparative clinical study to be conducted on patients suffering from primary dysmenorrhea. The intervention will be given for three consecutive menstrual cycles, and outcomes will be assessed based on reduction in pain intensity using Visual Analog Scale (VAS) and improvement in associated symptoms. 
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