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CTRI Number  CTRI/2021/12/038902 [Registered on: 24/12/2021] Trial Registered Prospectively
Last Modified On: 23/12/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To Study effect of Haritaki Churna in Pain during menstrual cycle (Primary Dysmenorrhoea). 
Scientific Title of Study   Open Randomized Control Clinical Trial Of Haritaki Churna In The Management Of Udavartini Yonivyapad with Special Reference To Primary Dysmenorrhoea. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vd Dilip Vitthal Katare 
Designation  Reader 
Affiliation  Hon.Shri.Annasaheb Dange Ayurved Medical College, Ashta. 
Address  Strirog and Prasutitanta OPD No. 4 Hon.Shri.Annasaheb Dange Ayurved Medical College Ashta,Tal-Walwa,Dist-Sangli MAHARASHTRA 416301 India
Strirog and Prasutitanta OPD No. 4 Hon.Shri.Annasaheb Dange Ayurved Medical College Ashta,Tal-Walwa,Dist-Sangli MAHARASHTRA 416301 India
Sangli
MAHARASHTRA
416301
India 
Phone  9881215521  
Fax    
Email  drdilipkatareashta@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vd Dilip Vitthal Katare 
Designation  Reader 
Affiliation  Hon.Shri.Annasaheb Dange Ayurved Medical College, Ashta. 
Address  Strirog and Prasutitanta OPD No. 4 Hon.Shri.Annasaheb Dange Ayurved Medical College Ashta,Tal-Walwa,Dist-Sangli MAHARASHTRA 416301 India
Strirog and Prasutitanta OPD No. 4 Hon.Shri.Annasaheb Dange Ayurved Medical College Ashta,Tal-Walwa,Dist-Sangli MAHARASHTRA 416301 India
Sangli
MAHARASHTRA
416301
India 
Phone  9881215521  
Fax    
Email  drdilipkatareashta@gmail.com  
 
Details of Contact Person
Public Query  
Name  vd Shubham Mali 
Designation  PG Scholar Prasuti Tantra evum Stree roga 
Affiliation  Hon.Shri.Annasaheb Dange Ayurved Medical College, Ashta. 
Address  Stirog and Prasutitantra OPD No. 4 Hon.Shri.Annasaheb Dange Ayurved Medical College Ashta,Tal-Walwa,Dist-Sangli MAHARASHTRA 416301 India
Stiroga and Prasutitantra OPD no. 4 Hon.Shri.Annasaheb Dange Ayurved Medical College Ashta,Tal-Walwa,Dist-Sangli MAHARASHTRA 416301 India
Sangli
MAHARASHTRA
416301
India 
Phone  8888739095  
Fax    
Email  drshubham9095@gmail.com  
 
Source of Monetary or Material Support  
Hon.Shri.Annasaheb Dange Ayurved Medical College,Ashta Tal-Walwa,Dist-Sangli Maharashtra 416301 India 
 
Primary Sponsor  
Name  HonShriAnnasaheb Dange Ayurved Medical CollegeAshta 
Address  Hon.Shri.Annasaheb Dange Ayurved Medical College,Ashta Tal-Walwa,Dist-Sangli Maharashtra 416301 India 
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 
Vd Shubham Mali  Dhanvantri Hospital,Ashta  Strirog and Prasutantra OPD no. 4 Hon.Shri.Annasaheb Dange Ayurved Medical College Ashta,Ta-Walwa,Dist-Sangli Maharashtra 416301 India
Sangli
MAHARASHTRA 		 8888739095

drshubham9095@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical 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,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Haritaki Churna, Reference: Dhanvantari Nighantu 1/206, Route: Oral, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Guda), Additional Information: 7 days before menses for 3 consective menstrual cycle.
2Comparator ArmDrugClassical(1) Medicine Name: Shatpushpa Churna, Reference: Kashyap samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Ghrita), Additional Information:
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  25.00 Year(s)
Gender  Female 
Details  1. Patients between age group of 15-25yr
2. Patients presenting with pratyatma lakshanas of Udavartini yoni vyapad.
3. Patients suffering for more than 3 consecutive cycle.
4. Ptient with regular menstrual cycle.
5. Patients of Madhym & Krura Koshtha.
6. Patients having a Vataj Prakruti. 
 
ExclusionCriteria 
Details  Patients with fibroid uterus, malignancy, uterine polyps, cervical polyps, PID,
endometriosis, IUCD’S etc., diseases related to urogenital system.
2. Patients with systemic disorders like diabetes mellitus, hypertension,tuberculosis etc.,Patient with mrudu koshta.
4. patient having secondary dysmenorrhoea.
5. Lactating mother.
6. Patients on hormonal therapy and OCP’s. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of Haritaki Churna in Udavartini Yonivyapad.  7 days before menses for 3 consecutive menstrual cycle 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the efficacy of Haritaki Churna and Shatapushpa Churna in Udavartini Yonivyapad.  7 days before menses for 3 consecutive menstrual cycle 
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
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)   07/01/2022 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Dysmenorrhoea means painful menstruation.
This condition appears similar to Udavartini Yoni Vyapad as described in Ayurveda.
 
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