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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:E70-E88||Metabolic disorders. Ayurveda Condition: ARTAVAVAHA-SROTODUSHTIH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
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. |