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CTRI Number  CTRI/2025/05/086132 [Registered on: 01/05/2025] Trial Registered Prospectively
Last Modified On: 03/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Study the effect of Lodhrabilwadi Kashaya in Udavartini Yonivyapad (Dysmenorrhea) 
Scientific Title of Study   Evaluation of the Efficacy of Lodhrabilwadi Kashaya in Udavartini Yonivyapad with respect to 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 Harshada Sunil Indalkar  
Designation  MS Scholar 
Affiliation  Dr.D.Y.Patil College of Ayurved and Research Centre , Pimpri,Pune,411018.  
Address  Opd No.2 , Stree Roga and Prasuti Tantra Department, Dr.D.Y.Patil College of Ayurved and Research Centre , Pimpri,Pune,411018.

Pune
MAHARASHTRA
411018
India 
Phone  9370305702  
Fax    
Email  harshadaindalkar6598@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jayashree Patil  
Designation  Professor  
Affiliation  Dr.D.Y.Patil College of Ayurved and Research Centre , Pimpri,Pune,411018. 
Address  Opd No.2 , Stree Roga and Prasuti Tantra Department, Dr.D.Y.Patil College of Ayurved and Research Centre , Pimpri,Pune,411018.
Opd No.2 , Stree Roga and Prasuti Tantra Department, Dr.D.Y.Patil College of Ayurved and Research Centre , Pimpri,Pune,411018.
Pune
MAHARASHTRA
411018
India 
Phone  9921244690  
Fax    
Email  jayupa.patil6@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jayashree Patil 
Designation  Professor 
Affiliation  Dr.D.Y.Patil College of Ayurved and Research Centre , Pimpri,Pune,411018 
Address  Opd No.2 , Stree Roga and Prasuti Tantra Department, Dr.D.Y.Patil College of Ayurved and Research Centre , Pimpri,Pune,411018.
Opd No.2 , Stree Roga and Prasuti Tantra Department, Dr.D.Y.Patil College of Ayurved and Research Centre , Pimpri,Pune,411018.
Pune
MAHARASHTRA
411018
India 
Phone  9921244690  
Fax    
Email  jayupa.patil6@gmail.com  
 
Source of Monetary or Material Support  
Dr.D.Y.Patil College of Ayurved and Research Centre , Pimpri,Pune,411018.  
 
Primary Sponsor  
Name  Dr.Harshada Sunil Indalkar 
Address  Dr.D.Y.Patil College of Ayurved and Research Centre , Pimpri,Pune,411018.  
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 Harshada Sunil Indalkar  Dr.D.Y.Patil College of Ayurved and Research Centre , Pimpri,Pune,411018.  OPd and Ipd Stree Roga and Prasuti Tantra Department ,Dr.D.Y.Patil College of Ayurved and Research Centre , Pimpri,Pune,411018.
Pune
MAHARASHTRA 		 9370305702

harshadaindalkar6598@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
DR DYPCA AND RC INSTITUTIONAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N946||Dysmenorrhea, unspecified. Ayurveda Condition: UDAVARTINI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Lodhrabilwadi Kashaya, Reference: Sahasrayoga Parisishta prakaran no 70 kashaya -Pacchotri Kuvaladi Kashaya, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 16 Days, anupAna/sahapAna: No, Additional Information: 5 days before menstruation and 3 days during menstruation for 2 consecutive cycles
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Patient suffering from painful menstruation for more than equal to 3 consecutive cycles  
 
ExclusionCriteria 
Details  1.K/C/O pelvic Pathology - Fibroid , Adenomyosis , Endometriosis.
2.Other Medical disorder like epilepsy , Anemia(Hb less than 9gm/dl. Heart disease , Diabetes.
3.Abnormal Uterine Bleeding .  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Effect of Lodhrabilwadi Kashaya in Udavartini Yonivyapad with respect to Dysmenorrhoea .
 
4 days before menstrual cycle upto three days during menstrual cycle for 2 consecutive menstrual cycles 
 
Secondary Outcome  
Outcome  TimePoints 
To Observe Adverse Effect of Lodhrabilwadi Kashaya if any .  4 days before menstrual cycle upto three days during menstrual cycle for 2 consecutive menstrual cycles 
 
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/ Phase 3 
Date of First Enrollment (India)   01/05/2025 
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   This a Single Arm Clinical Study .The Aim of Study to Evaluate The Efficacy Of Lodhrabilwadi kashaya In Udavartini Yonivyapad.Total 30 patients will be enrolled and 10 ml Lodhrabilwadi kashaya will be given empty stomach.The age Group taken for study is from 18 years to 35 years of females. 
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