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
|
|
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
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
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. |