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CTRI Number  CTRI/2021/07/034672 [Registered on: 07/07/2021] Trial Registered Prospectively
Last Modified On: 06/07/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   RELATION OF MENTAL STRESS WITH THE SEVERITY OF MENSTRUAL PAIN.  
Scientific Title of Study   CORRELATION OF PSYCHOLOGICAL STRESS WITH THE SEVERITY OF MENSTRUAL PAIN IN UDAVARTA YONI VYAPAD (PRIMARY DYSMENORRHEA)- A CROSS SECTIONAL ANALYTICAL STUDY. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aditaya Nath Tewari 
Designation  Associate Professor 
Affiliation  Chaudhary Brahm Prakash Ayurved Charak Sansthan. 
Address  Postgraduate Department of Rog Nidan Evum Vikriti Vigyan, Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar Najafgarh.

South West
DELHI
110073
India 
Phone  9711434847  
Fax    
Email  dr.aditaya@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Aditaya Nath Tewari 
Designation  Associate Professor 
Affiliation  Chaudhary Brahm Prakash Ayurved Charak Sansthan. 
Address  Postgraduate Department of Rog Nidan Evum Vikriti Vigyan, Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar Najafgarh.

South West
DELHI
110073
India 
Phone  9711434847  
Fax    
Email  dr.aditaya@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vasudha Kaul  
Designation  PG SCHOLAR 
Affiliation  Chaudhary Brahm Prakash Ayurved Charak Sansthan 
Address  Postgraduate Department of Rog Nidan Evum Vikriti Vigyan, Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar Najafgarh.

South West
DELHI
110073
India 
Phone  9811794913  
Fax    
Email  vasudhakaul93@gmail.com  
 
Source of Monetary or Material Support  
Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabur, Najafgarh, New Delhi. 
 
Primary Sponsor  
Name  Chaudhary Brahm Prakash Ayurved Charak Sansthan 
Address  Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar Najafgarh, New Delhi-73 
Type of Sponsor  Government medical college 
 
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 VASUDHA KAUL  Chaudhary Brahm Prakash Ayurved Charak Sansthan  PG DEPARTMENT OF ROG NIDAN EVAM VIKRITI VIGYAN Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh New Delhi 73.
South West
DELHI 		 9811794913

vasudhakaul93@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institution Ethical Committee  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 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1. Painful menstruation for atleast 3 consecutive cycles with regular cycles having normal bleeding phase of 21-35 days .
2. Duration of menstrual pain lasting for 2-3 days.
3. Not associated with any organic reproductive system abnormalities(Excluded clinically). 
 
ExclusionCriteria 
Details  1.Cases of Secondary Dysmenorrhoea.
2.Associated with leiomyoma(Fibroid) of uterus, ovarian cyst, endometriosis.
3.Associated with PID,Hydrosalpinx.
4.Associated with any serious systemic disorders likely to influence menstrual cycle i.e DM & HTN.
5.History of malignancy of pelvic organs.
6.History of Hypo & Hyper Thyroidism.
7.Women using an IUD/Oral Contraceptive Pills.
8.Patients who is mentally not sound.
9.Non-cooperative patients.
10.Patients already undergoing Treatment. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Findings of study will be beneficial in the clinical management of Udavarta Yonivyapad(Primary Dysmenorrhea) by establishing the relationship between psychological stress with the severity of menstrual pain via timely counseling and sensitization of society about the ill effects of Stress on the female reproductive system, which in turn will help to rationally use drugs for the treatment.  06 months  
 
Secondary Outcome  
Outcome  TimePoints 
To study the detailed pathogenesis of the Udavarta Yonivyapad(Primary dysmenorrhea) and the Contribution of Stress in its pathogenesis as a triggering factor.  8 weeks 
 
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   N/A 
Date of First Enrollment (India)   10/07/2021 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   The data will be published in UGC approved journals. 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   A hospital based Cross sectional Analytical Study will be conducted to examine the possible relationship between Psychological stress and Severity of Menstrual Pain in the patients of Udavarta YoniVypad aged 15 to 35 years (Cases) who are already diagnosed with Primary dysmenorrhea, reporting in the OPD / IPD once before the start of menstruation according to the duration of each individual’s cycle this data will be, compared with a CONTROL GROUP i.e Subjects outside campus undergoing Normal menstruation via detailed questionnaire proforma and 2 scientifically acclaimed Scales in to establish the causal relationship (if any ) between the Cause (stress) and Outcome(Pain severity).   
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