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CTRI Number  CTRI/2023/02/050032 [Registered on: 24/02/2023] Trial Registered Prospectively
Last Modified On: 22/02/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Relation between menstrual irregularities and prakriti. 
Scientific Title of Study   An observational study to assess the prevalence of menstrual irregularities and its association with prakriti in students of National Institute Of Ayurveda  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrPunit Chaturvedi  
Designation  Assistant Professor,Department of Swasthavritt Evum Yoga 
Affiliation  NATIONAL INSTITUTE OF AYURVEDA  
Address  NATIONAL INSTITUTE OF AYURVEDA,Madhav Vilas Palace, Amer Rd, Jaipur, Rajasthan

Jaipur
RAJASTHAN
302002
India 
Phone  9024458253  
Fax    
Email  pchaturvedi72@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrPunit Chaturvedi  
Designation  Assistant Professor,Department of Swasthavritt Evum Yoga 
Affiliation  NATIONAL INSTITUTE OF AYURVEDA  
Address  NATIONAL INSTITUTE OF AYURVEDA,Madhav Vilas Palace, Amer Rd, Jaipur, Rajasthan

Jaipur
RAJASTHAN
302002
India 
Phone  9024458253  
Fax    
Email  pchaturvedi72@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Pragati Sharma  
Designation  BAMS 3rd Year student  
Affiliation  NATIONAL INSTITUTE OF AYURVEDA  
Address  NATIONAL INSTITUTE OF AYURVEDA,Madhav Vilas Palace, Amer Rd, Jaipur, Rajasthan

Jaipur
RAJASTHAN
302002
India 
Phone  9636304199  
Fax    
Email  pragatijaipur9@gmail.com  
 
Source of Monetary or Material Support  
National Institute Of Ayurveda,Madhav vilas palace jaipur rajasthan 
 
Primary Sponsor  
Name  CCRAS 
Address  Jawahar Lal Nehru Bhartiya Chikitsa Avum Homeopathy Anusandhan Bhavan No.61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi - 110058 ( India ) 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NATIONAL INSTITUTE OF AYURVEDA  Madhav Vilas, Jorawar Singh Gate, Amer Road, Jaipur, Rajasthan 302002 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr PUNIT CHATURVEDI  NATIONAL INSTITUTE OF AYURVEDA  Department of Swasthvrit evum yoga,2nd floor of college.
Jaipur
RAJASTHAN 
9024458253

pchaturvedi72@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N80-N98||Noninflammatory disorders of female genital tract. Ayurveda Condition: ARTAVADOSHAH/ARTAVADUSHTIH/RAJODOSHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  30.00 Year(s)
Gender  Female 
Details  1.FEMALE STUDENTS BETWEEN THE AGE GROUP 16 TO 30 YEARS.
2.THOSE WHO ATTAIN MENARCHE BEFORE TWO YEARS.
3.FEMALES HAVING MENSTRUAL IRREGULARITIES. 
 
ExclusionCriteria 
Details  1.THOSE WHO ARE HAVING HISTORY OF MENTAL ILLNESS.
2.PREGNANT AND LACTATING STUDENTS.
3.THOSE WHO ARE SUFFERING FROM SEVERE SYSTEMIC ILLNESS AND ANY TYPE OF CARCINOMA.
4.THOSE WHO ARE NOT WILLING TO TAKE PART IN STUDY. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Prevalence of menstrual irregularities will be assessed and its association with prakriti will be determined.  2 months 
 
Secondary Outcome  
Outcome  TimePoints 
Easiness in prescribing ayurveda based diet plan suitable to prakriti type  2 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   N/A 
Date of First Enrollment (India)   01/03/2023 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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)?  

Response - NO
Brief Summary   MENSTRUATION IS THE CYCLIC DISCHARGE OF BLOOD AND MUCOSAL TISSUE FROM INNER LINING OF THE UTERUS THROUGH VAGINA.MENSTRUATION OCCURS DUE TO RISE AND FALL OF HORMONES AND IS COORDINATED BY HYPOTHALAMUS,PITUITARY,OVARY AND UTERUS. ALTERATIONS IN THESE CAN CAUSE MENSTRUAL IRREGULARITIES LIKE AMENORRHOEA, MENORRHAGIA, POLYMENORRHOEA,OLIGOMENORRHOEA.

STRESS, OBESITY,SMOKING,JUNK FOOD,IRREGULAR SLEEP WAKE CYCLE ARE SOME REASONS WHICH CAN ALSO AFFECT A REGULAR MENSTRUATION. THE LIFESTYLE DISORDERS NEED TO BE CURED BY INCLUSION OF SWASTHAVRITT AND YOGA.  PRESCRIPTIONS DONE BY AYURVEDIC PRACTITIONER BECOMES APPROPRIATE IF PRAKRITI OF HIS PATIENTS IS ASSESSWD PROPERLY.  PRAKRITI STANDS FOR THE NATURE OF BODY IN TERMS OF DOSHA AND IS DECIDED AT THE TIME OF CONCEPTION ACCORDING TO THE PREDOMINANCE OF DOSHA . IT DOES NOT CHANGE DURING WHOLE LIFE AND IS RESPONSIBLE FOR PHYSICAL AND MENTAL CHARACTERISTICS OF AN INDIVIDUAL. WHILE EXPLAINING SHUDDH ARTAVA LAKSHAN, ACHARYA BHAVMISHRA MENTIONS THAT DIFFERENCES IN COLOURS OF SHUDDHA ARTAVA ARE DUE TO VATADI PRAKRITI. THIS IMPLIES THAT PRAKRITI IS HAVING IMPACT ON MENSTRUATION. THE INCLUSION OF RAJASWALA PARICHARYA DURING MENSES AND A PROPER AYURVEDA PRESCRIBED DIET PLAN SUITABLE TO THE PRAKRITI TYPE MAY LEAD TO A HEALTHY MENSTRUAL CYCLE. PRAKRITI HELPS IN DECIDING APPROPRIATE DIETARY REQUIREMENT FOR THEM. DIETARY SUGGESTIONS PRESCRIBED ACCORDING TO PRAKRITI, NEED TO MAKE SMALL CHANGES IN THEIR FOOD CHOICES AND THE EATING HABITS .SO, THE PRESENT STUDY IS AIMED TO ASSESS THE PREVALENCE OF MENSTRUAL IRREGULARITIES IN STUDENTS OF NATIONAL INSTITUTE OF AYURVEDA AND TO ASSESS ITS ASSOCIATION WITH PRAKRITI , SO THAT IT MAY GUIDE US TO PRESCRIBE PROPER RAJASWALA PARICHARYA AND DIETARY GUIDELINES TO PREVENT SUCH ABNORMALITIES SPECIFIC TO EACH PRAKRITI.
 
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