| CTRI Number |
CTRI/2025/01/079648 [Registered on: 28/01/2025] Trial Registered Prospectively |
| Last Modified On: |
13/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
find to relationship between Poly cystic ovarian syndrome and different body type. |
|
Scientific Title of Study
|
“A CROSS-SECTIONAL OBSERVATIONAL STUDY IN THE PATIENT OF PCOS W.S.R OF DIFFERENT DEHA PRAKRITI” |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Foram Patel |
| Designation |
P G Scholar |
| Affiliation |
J S Ayurved Mahavidhyalaya |
| Address |
Department of Kriya Sharira
J S Ayurved Mahavidhyalaya
Nadiad 387001
Gujarat
Kheda
GUJARAT
387001
India |
| Phone |
8320356659 |
| Fax |
|
| Email |
forampatel7007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Haripriya R Panjabi |
| Designation |
Associate professor |
| Affiliation |
J S Ayurved Mahavidhyalaya |
| Address |
Department of Kriya Sharira
J S Ayurved Mahavidhyalaya
Nadiad 387001
Gujarat
Kheda
GUJARAT
387001
India |
| Phone |
9723569239 |
| Fax |
|
| Email |
priyapanjabi1608@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mularam Suthar |
| Designation |
Assistant professor |
| Affiliation |
J S Ayurved Mahavidhyalaya |
| Address |
Department of Kriya Sharira
J S Ayurved Mahavidhyalaya
Nadiad 387001
Gujarat
Kheda
GUJARAT
387001
India |
| Phone |
9783585696 |
| Fax |
|
| Email |
drmularam@gmail.com |
|
|
Source of Monetary or Material Support
|
| J S Ayurved Mahavidhyalaya College Road
Nadiad, 387001 Gujarat India |
|
|
Primary Sponsor
|
| Name |
J S Ayurved Mahavidhyalaya |
| Address |
J S Ayurved Mahavidhyalaya College Road
Nadiad 387001 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Foram K Patel |
J S Ayurveda Mahvidhyalaya Nadiad |
132 OPD PTSR Department Of P D Patel Ayurveda Hospital College Road Nadiad 387001
Kheda
GUJARAT |
8320356659
forampatel7007@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee for Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E282||Polycystic ovarian syndrome. Ayurveda Condition: GRANTHIBUTA-ARTAVADUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Confirm patients of PCOS with USG abdomen is Age group between 18-35 years.
In Prakrit assessment of the patients, the dominant Dosha will be included .
|
|
| ExclusionCriteria |
| Details |
Pelvic diseases like (Endometriosis, Hydrosalpinx, Fibroid uterus etc) causing
Oligomenorrhoea and Anovulation.
Organic lesions of reproductive tract like T.B, Carcinoma and congenital deformities.
Cushing’s syndrome
Hypothyroidism
Patients with severity or overlapped Prakriti symptoms.(e.g. Upachaya in kapha prakriti)
The women in use of oral contraceptives( current or within the last 6 month).
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Find out association between PCOS and Deha Prakriti |
52 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Prevalence of PCOS in different Prakriti |
52 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
10/02/2025 |
| 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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
AIM( Research hypothesis):- To study Deha Prakriti in the patients of PCOS. SUBJECTIVES:- To determine Deha Prakriti in the know case of PCOS, by using a validated Prakriti proforma. Artava Pariksha will be assessed using Artava Parikshan questionary. Severity of PCOS Symptoms assessed by Ferrimen and Gallwey Scoring scale Research Question:- Is there any association between PCOS patients and Deha Prakriti. Want to identify which type of Deha Prakriti has severity of PCOS symptoms So, this pilot study is taken to help for the further study. |