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CTRI Number  CTRI/2020/07/026892 [Registered on: 29/07/2020] Trial Registered Prospectively
Last Modified On: 10/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Ayurvedic treatment of Kashtartava(Primary Dysmenorrhoea) 
Scientific Title of Study   Clinical evaluation of the efficacy of Ayurvedic treatment regimen in the management of Kashtartava(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  Dr Kamini Dhiman 
Designation  Associate Professor 
Affiliation  All India Institute of Ayurveda, New Delhi 
Address  Department of SRPT, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi

South
DELHI
110076
India 
Phone  8512813414  
Fax    
Email  kd44ayu@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Kamini Dhiman 
Designation  Associate Professor 
Affiliation  All India Institute of Ayurveda, New Delhi 
Address  Department of SRPT, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi

South
DELHI
110076
India 
Phone  8512813414  
Fax    
Email  kd44ayu@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Kamini Dhiman 
Designation  Associate Professor 
Affiliation  All India Institute of Ayurveda, New Delhi 
Address  Department of SRPT, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi

South
DELHI
110076
India 
Phone  8512813414  
Fax    
Email  kd44ayu@yahoo.co.in  
 
Source of Monetary or Material Support  
Indian Council of Medical Research V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi 110029, India 
 
Primary Sponsor  
Name  ICMR 
Address  V. Ramalingaswami Bhawan, Ansari Nagar, New Delhi 110029 
Type of Sponsor  Research institution 
 
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 Kamini Dhiman  All India Institute of Ayurveda  Department of SRPT, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi
South
DELHI 		 8512813414

kd44ayu@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute of Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N944||Primary dysmenorrhea,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1 Kuberaksha Vati 2 Dashmoola Taila Matra Vasti days after cessation of bleeding phase of the menstrual cycle.   1 Kuberaksha Vati 1 gm three times a day orally with Luke warm water after food. 2 Dashmoola Taila Matra Vasti 60 ml per day at 9 am to 11 am per rectal route for 7 days after cessation of bleeding phase of the menstrual cycle. 
Comparator Agent  Tablet Mafenamic acid and Dicyclomine hydrochloride  Tablet Mafenamic acid in the dose of 500 mg plus Dicyclomine hydrochloride 20 mg will be given to the patients in the dose of one tablet as and when required as per the episodes of pain. 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  24.00 Year(s)
Gender  Female 
Details  Females of age group of 15 to 24 years

At least 3 painful cycle (21-35 days’ cycle) in last 6 cycles and intensity of pain during menstruation ≥ 40 mm (as per VAS)

Duration of menstrual pain ≥ 1 day

Able and willing to participate and provide signed informed consent.
 
 
ExclusionCriteria 
Details  Patients having Secondary Dysmenorrhoea

Patients on prolonged (>2weeks) medication with corticosteroids, anti depressants anticholinergic or any systemic/chronic illness which may have effect on menstrual cycle

Planning for Pregnancy during the treatment period and lactation

Patients having any mental / psychiatric illness will be excluded
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in the intensity of menstrual pain by using VAS scale  At base line, at the
end of 1st, 2nd, 3 rd, 4 th, 5th, and 6th menstrual cycle 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in other signs and symptoms by using Verbal Multi-dimensional scoring system and Menstrual Distress questionnaire

Changes in the quality of life of the study participants by using Health Survey – SF – 36 Questionnaire (RAND)

Decreased frequency of analgesic intake  		 Changes in other signs and symptoms Time frame: At base line, at the end of 1st, 2nd , 3rd , 4th, 5th, and 6th menstrual cycle
Changes in the quality of life of the study participants by using Health Survey – SF – 36 Time frame: At baseline, 90th and 180th day

Time frame: At base line, At base line, at the end of 1st, 2nd, 3rd, 4th, 5th, and 6th menstrual cycle 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="171" 
Phase of Trial   N/A 
Date of First Enrollment (India)   03/12/2020 
Date of Study Completion (India) 20/02/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="11"
Days="30" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Research project - Clinical Evaluation of the efficacy of Ayurvedic treatment regimen in the management of Kashtartava (Primary Dysmenorrhoea ) is approved and DSMB has  already given clearance. In the view of pendamic going on, study may take sometime to start as local therapy is to be done in the study.  
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