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CTRI Number  CTRI/2020/01/022843 [Registered on: 17/01/2020] Trial Registered Prospectively
Last Modified On: 16/01/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   A retrospective study to assess the prakruti(constitutional trait) and its relationship with premenstrual syndrome by comparing cases and controls.  
Scientific Title of Study   ASSESSMENT OF PRAKRUTI AND ITS RELATIONSHIP WITH PREMENSTRUAL SYNDROME – A CASE CONTROL STUDY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
IEC-AIMS-2019-AYUR-158  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aparna CR 
Designation  Postgraduation Scholar 
Affiliation  Amrita School of Ayurveda 
Address  Amrita School of Ayurveda, Amritapuri; Amrita Viswavidyapeetha; India

Kollam
KERALA
690525
India 
Phone  04762899688  
Fax  04762899681  
Email  craps2610@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shaithya Raj 
Designation  Associate Professor 
Affiliation  Amrita School of Ayurveda 
Address  Dept of Streeroga & Prasutitantra Amrita School of Ayurveda Amritapuri Amrita Viswavidyapeetha India
Amrita School of Ayurveda Amritapuri Amrita Viswavidyapeetha India
Kollam
KERALA
690525
India 
Phone  04762899688  
Fax    
Email  shaithya.raj@gmail.com  
 
Details of Contact Person
Public Query  
Name  Aparna CR 
Designation  Postgraduation Scholar 
Affiliation  Amrita School of Ayurveda 
Address  Amrita School of Ayurveda, Amritapuri; Amrita Viswavidyapeetha; India

Kollam
KERALA
690525
India 
Phone  04762899688  
Fax  04762899681  
Email  craps2610@gmail.com  
 
Source of Monetary or Material Support  
Amrita School of Ayurveda 
 
Primary Sponsor  
Name  Aparna CR 
Address  Amrita School of Ayurveda Amritapuri Amrita Viswavidyapeetha India 
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 
Aparna C R  Amrita Ayurveda Hospital  Amrita School of Ayurveda Amritapuri Amrita Vishwavidyapeetham India
Kollam
KERALA 		 9496721913
04762899681
craps2610@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-AIMS-2019-AYUR-158  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F59||Unspecified behavioral syndromes associated with physiological disturbances and physical factors,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Women with normal regular menstrual cycles 
 
ExclusionCriteria 
Details   Any known cases of systemic diseases like hypertension, thyroid disorders, diabetes mellitus.
 Under medication for any psychological & psychiatric disorders.
 Women under hormone therapy or hormonal contraception.
 Women indulged in drug abuse  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Prakruti assessment by Revised Prototype prakruti analysis tool
2.Premenstrual symptom screening tool
3.Premenstrual syndrome scale
4.Daily record of severity of problems 		 Revised Prototype prakruti analysis tool- Day1
2.Premenstrual symptom screening tool-Day1
3.Premenstrual syndrome scale-Day1
4.Daily record of severity of problems- Daily for 2 months 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
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   N/A 
Date of First Enrollment (India)   20/01/2020 
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)?  

Brief Summary   Premenstrual syndrome is a psychoneuroendocrine disorder of unknown etiology,often noticed just prior to menstruation.There is cyclic appearance of a large number of symptomsduring the last 7-10 days of menstrual cycle.It is certainly the cause of much individual misery and family disharmony, absenteeism and even criminal acts like murder and suicide.Premenstrual syndrome has no direct reference in ayurvedic literature. Acharya Charaka has mentioned dasavidha pareeksha which includes prakruti pareeksha also., as a tool to examine a patient and thereby assess the relation between prakruti and vikruti. Hence the assessment of thye relation between  prakruti  and premenstrual syndrome can invariably help in the identification of risk group and ayurvedic clinical approach, by understanding the samprapti and sampraptighatakas of the disease. LLiterary aspects of the study will be collected from classical ayurveda texts and textbooks of contemporary science updated with journals and e databases, ASA library and previous works done on same topic.The subjects will be selected from Amritapuri campus and Amrita School of Ayurveda. They will be screened for premenstrual syndrome and prakruti will also be assesssed.50 subjects affected with premenstrual syndrome and 50 subjects not affected with premenstrual syndrome  will be selected satisfying the inclusion criteria. Then the results will be analysed statistically and specific prakruti may be identified as a risk factor for premenstrual syndrome.  
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