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CTRI Number  CTRI/2024/10/075552 [Registered on: 21/10/2024] Trial Registered Prospectively
Last Modified On: 18/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A CLINICAL STUDY TO EVALUATE THE EFFECT OF AYURVEDIC MEDICINE ON GARBHASHAYA SHUDDHI IN SUTIKAVASTHA 
Scientific Title of Study   Randomised controlled clinical trial of panchakola churna and latakaranj churna for garbhyashaya shuddhi in sutikavastha.  
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 Trupti Pitambar Bhosale 
Designation  PG Scholar 
Affiliation  Tilak Ayurveda Mahavidyalaya 
Address  Department of streeroga and Prasutitantra Tilak Ayurved Mahavidhyalaya Rasta Peth Pune

Pune
MAHARASHTRA
411011
India 
Phone  9604468111  
Fax    
Email  truptibhosale2121@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR RAHUL JAYPRAKASH GARUDKAR 
Designation  ASSOCIATE PROFESSOR  
Affiliation  Tilak Ayurved Mahavidhyalaya Rasta Peth Pune 
Address  Department of streeroga and Prasutitantra Tilak Ayurved Mahavidhyalaya Rasta Peth Pune

Pune
MAHARASHTRA
411011
India 
Phone  9822777367  
Fax    
Email  drrahulgarudkar@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Rahul Jayprakash Garudkar. 
Designation  Associate professor 
Affiliation  Tilak Ayurved Mahavidhyalaya Rasta Peth Pune 
Address  Department of streeroga and Prasutitantra Tilak Ayurved Mahavidhyalaya Rasta Peth Pune

Pune
MAHARASHTRA
411011
India 
Phone  9822777367  
Fax    
Email  drrahulgarudkar@yahoo.com  
 
Source of Monetary or Material Support  
Tilak Ayurved Mahavidhyalaya And Seth Tarachand Ramnath Charitable Ayurvedic Hospital Rasta Peth Dist-Pune 411011 ,Maharashtra,India 
 
Primary Sponsor  
Name  Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath Charitable Ayurved Hospital 
Address  Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath Charitable Ayurved Hospital,Rasta Peth,Pune 411011,maharashtra,India 
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 Trupti Pitambar Bhosale  Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath Charitable Ayurved Hospital  OPD NO 11 AND IPD of Department of streeroga and prasutitantra Rasta peth
Pune
MAHARASHTRA 		 9604468111

truptibhosale2121@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee, Tilak Ayurved Mahavidyalaya ,Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N859||Noninflammatory disorder of uterus, unspecified. Ayurveda Condition: SUTIKAROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Panchakol Churna, Reference: Sushruta sharira sthana , Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Samudga, Duration: 21 Days, anupAna/sahapAna: Yes(details: -Gudaushanodaka), Additional Information: -500mg BD for 21 days
2Comparator ArmDrugClassical(1) Medicine Name: Latakaranj churna, Reference: Bhavprakash Nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Samudga, Duration: 21 Days, anupAna/sahapAna: Yes(details: -jala), Additional Information: -500 mg BD for 21 days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1) Patient with normal delivery
2) Age of patient between 18 to 40 year
3) Irrespective of Parity  
 
ExclusionCriteria 
Details  1) Case with cesarian delivery
2) High risk pregnancy with systemic diseases
3) case with PIH, Pre-Eclampsia, PPH
4) Pregnancy with Heart disease and Severe Anemia
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Garbhashaya shuddhi, Samyak agni, Prakruta stanya utpatti   1st week ,2nd week ,3rd week 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  0 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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/ Phase 3 
Date of First Enrollment (India)   29/10/2024 
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="1"
Months="6"
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 - NO
Brief Summary   Sutika kala is very critical life in women life, as she is Kshati vrani, durbala, dhatukshaya and agnimandya so because of this change physiological state she becomes suceptible to various infection .it is necessary to prevent those infection and puerperal sepsis and ultemately maintan her health throught post-partum period.This Work If proved to be effective on garbhashaya shuddhi  in sutikavastha , will be beneficial for society as it will lead to healthy motherhood.  
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