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CTRI Number  CTRI/2022/01/039592 [Registered on: 20/01/2022] Trial Registered Prospectively
Last Modified On: 19/01/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Observational Study on relation of Prakriti and Menstrual Patterns in Polycystic ovarian syndrome. 
Scientific Title of Study   observational study on relation of Prakriti and Menstrual patterns in Polycystic ovarian syndrome. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrPoonam Choudhary 
Designation  Assisstant Professor 
Affiliation  National institute of Ayurveda, Deemed to be university Jaipur 
Address  Room no.302, Prasuti tantra & Stree roga Department, National institute of Ayurveda Deemed to be university Jaipur 302002
National institute of Ayurveda Deemed to be university Jaipur 302002
Jaipur
RAJASTHAN
302002
India 
Phone  9352311106  
Fax  0  
Email  poonam.18veena@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrPoonam Choudhary 
Designation  Assisstant Professor 
Affiliation  National institute of Ayurveda, Deemed to be university Jaipur 
Address  Room no.302, prasuti & stree roga department, National institute of Ayurveda Deemed to be university Jaipur 302002
National institute of Ayurveda Deemed to be university Jaipur 302002
Jaipur
RAJASTHAN
302002
India 
Phone  9352311106  
Fax  0  
Email  poonam.18veena@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrPoonam Choudhary 
Designation  Assisstant Professor 
Affiliation  National institute of Ayurveda, Deemed to be university Jaipur 
Address  Room no 302, prasuti tantra & stree roga department, National institute of Ayurveda Deemed to be university Jaipur 302002
National institute of Ayurveda Deemed to be university Jaipur 302002
Jaipur
RAJASTHAN
302002
India 
Phone  9352311106  
Fax  0  
Email  poonam.18veena@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda 
 
Primary Sponsor  
Name  National Institute of Ayurveda 
Address  Madhav vilas palace, Amer road, jaipur, rajasthan 
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 Poonam Choudhary  OPD & IPD of prasuti tantra and stree roga DepartmentNational Institute of Ayurveda  Madhav Vilas Palace Amer road Jaipur Rajasthan 302002
Jaipur
RAJASTHAN 
9352311106
0
poonam.18veena@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
National Institute of Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E70-E88||Metabolic disorders. Ayurveda Condition: ARTAVAVAHA-SROTODUSHTIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Patients aged between 18-40 years, married or unmarried
fulfilling at least 2 of following 3 criteria:
(Rotterdam revised criteria for PCOS, 2003)
1. Oligomenorrhoea, and / or Anovulation
2. Hyperandrogenism (clinical and/or bio-chemical)
3. PCO- diagnosed by USG 
 
ExclusionCriteria 
Details  .Patients having any other disease causing
oligomenorrhoea and anovulation excluding PCOS on above
criteria.
2.Patients suffering from hyperprolactinemia, Thyroid
abnormalities, adrenal hyperplasia, severe insulin resistance,
androgen secreting neoplasm, Cushing’s syndrome are
excluded.
3.Current or previous (within last 3 months) use of OC Pills,
Gluco-corticoids, anti-androgens, ovulation induction
agents, anti diabetic, anti-obesity drugs, or other hormonal
drug 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To know about the relationship between Prakriti and
Menstrual patterns in Polycystic ovarian syndrome.
 
one year 
 
Secondary Outcome  
Outcome  TimePoints 
To know about the relationship between Prakriti and
Clinical features (Acne, Hirsutism, Obesity) in Polycystic
ovarian syndrome. 
1 year 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   20/01/2022 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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   The  temperament and prototype of the Rajasrava may be some relation with prakriti. Prakriti of individual would be an influencing factor for variation in the characteristics of Rajapravritti. Menstrual patterns and clinical symptoms in PCOS patients are variable. These variability in symptoms are due to her prakriti. Hence there is need of study in this direction. So, by understanding the nature of prakriti and menstrual pattern in PCOS women will open new aspect for treatment modalities and if we know prakriti we have to treat disease in intial stage. 
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