| CTRI Number |
CTRI/2025/01/079648 [Registered on: 28/01/2025] Trial Registered Prospectively |
| Last Modified On: |
13/08/2026 |
| 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)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/02/2025 |
| Date of Study Completion (India) |
30/04/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
This will be submitted in form of dissertation. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
A cross-sectional
observational study was conducted to assess Deha Prakriti in diagnosed patients
of Polycystic Ovary Syndrome (PCOS). Among 89 screened individuals, 60
participants aged 18–35 years fulfilling the inclusion criteria were enrolled.
Deha Prakriti was assessed using a validated proforma, while menstrual
characteristics and clinical manifestations were evaluated using standardized
assessment tools. Vata-Pradhana Prakriti was predominant (43.33%), followed by
Pitta-Pradhana (35.00%) and Kapha-Pradhana (21.67%). Menstrual irregularity was
observed in 93.33% participants, while 56.66% were overweight or obese.
Mild-to-severe hirsutism was observed in 83.33%. The findings indicate
substantial constitutional and clinical variability among patients with PCOS. |