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CTRI Number  CTRI/2021/04/032668 [Registered on: 08/04/2021] Trial Registered Prospectively
Last Modified On: 21/07/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Siddha
Other (Specify) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study on Kalingadhy thailam and Inji chooranam for the management of Primary Dysmennorrhea 
Scientific Title of Study   An open Double arm Randomized Comparative Clinical trial to Evaluate and Compare the Efficacy of Siddha herbal formulations Kalingadhy thailam and Inji Churanam in reducing pain among the Reproductive age group with Dhoorasoolai (Primary dysmenorrhea NSMC Code: ZAA1.8) at SCRI OPD Chennai- A pilot study. 
Trial Acronym  EKIPD 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr S Esaivani 
Designation  Research Officer Siddha 
Affiliation  Siddha Central Research Institute 
Address  A room opposite to lift in 3rd floor, Department of clinical research, Siddha central research institute, Arumbakkam
Siddha Central Research Institute Anna Hospital Campus Arumbakkam Chennai-600106
Chennai
TAMIL NADU
600106
India 
Phone  9597322218  
Fax    
Email  esaivani08@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrPSathiyarajeswaran 
Designation  Research Officer Siddha 
Affiliation  Siddha Central Research Institute 
Address  A room opposite to lift in 2nd floor, Assistant Director in-charge for Siddha central research institute, Siddha central research institute Arumbakkam, Chennai

Chennai
TAMIL NADU
600106
India 
Phone  8754495186  
Fax    
Email  crisiddha@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrPSathiyarajeswaran 
Designation  Research Officer Siddha 
Affiliation  Siddha Central Research Institute 
Address  A room opposite to lift in 2nd floor, Assistant Director in-charge for Siddha central research institute, Siddha central research institute Arumbakkam, Chennai

Chennai
TAMIL NADU
600106
India 
Phone  8754495186  
Fax    
Email  crisiddha@gmail.com  
 
Source of Monetary or Material Support  
Central council for Research in Siddha 
 
Primary Sponsor  
Name  Central Council for Research in Siddha 
Address  Central Council for Research in Siddha Anna Hospital Campus Arumbakkam Chennai-600106 Chennai. 
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 P Sathiyarajeswaran  Siddha Central Research Institute Hospital  Room no 1 Reproductive and Child health division Department of clinical research Siddha Central Research Institute Arumbakkam Chennai
Chennai
TAMIL NADU 		 9443579540

crisiddha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee, Siddha Central Research Institute.   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Arm-1Kalingadhy thailam route of administration-oral only at morning empty stomach   trial drugs will be given only on menstrual period (3days) for 3 menstrual cycles Dose first day-15ml second day-10ml third day-5ml 
Comparator Agent  Arm-2 Inji choornam Route of administration-Oral  trial drugs will be given only on menstrual period (3days) for 3 menstrual cycles Dose-2gm morning and night after food with Hot water 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1 Trial participants who are at the age group of 18-35 years
2 Menstrual pain for more than 3 consecutive regular menstrual cycle without pelvic organ pathology
3 Complaints of primary dysmenorrhea from menarche or shortly after (6–24 months) menarche.
4 Regular menstrual cycle of 24 to 32 days
5 Severe dysmenorrhea with 8-12 score using WaLLID tool
 
 
ExclusionCriteria 
Details  1 Study participants who have pelvic inflammatory diseases
2 Irregular menstrual cycle
3 Secondary dysmenorrhea associated with ovarian cyst, endometriosis and fibroid (excluded clinically and radio logically)
4 Pain abdomen associated with excessive BPV
5 Having oral contraceptive pills and IUCD (Intrauterine contraceptive pills)
6 Who are under the treatment of hormonal therapy
7 who are pregnant/planning to pregnant, Lactating mother 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The primary outcome measures will be evaluating and comparing the efficacy of kalingadhy thailam and Inchi choornam in reducing pain among women with Dhoora soolai (Primary Dysmennorhea) by using WaLLID tool
 		 Baseline and 3rd day of every month of intervention and follow up
totally 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Measuring the status of hormones before and after the administration of trial drugs.
Measuring safety of the trial drug kalingadhy thailam
 		 Baseline
After 3 months
after 6 months 
 
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   Phase 2 
Date of First Enrollment (India)   17/04/2021 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This is an Interventional study to evaluate and compare the efficacy of two Siddha formulations. Adolescence is the transitional period marked with the onset of menarche an important milestone which is often associated with problems of irregular menstruation, excessive bleeding and dysmenorrhea. Current evidence suggests that dysmenorrhea happen due to myometrial contraction resulting from secretion of prostaglandin during secretary phase of endometrium. Primary aim of the study is to evaluate and compare the efficacy of kalingadhy thailam and Inji choornam in reducing pain among women in Reproductive age group with primary dysmenorrhea. menstrual pain will be assessed using WaLLID tool. Secondary aim is to assess the safety and status of Hormones after the administration of Kalingadhy thailam and Inji choornam. Prostaglandin F2 alpha will be measured in both venous blood and Menstrual blood. 
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