| CTRI Number |
CTRI/2024/04/065426 [Registered on: 08/04/2024] Trial Registered Prospectively |
| Last Modified On: |
25/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Survey Study |
| Study Design |
Other |
|
Public Title of Study
|
An observational study to Udara pramana (anthropometry measurement of abdomen)and jalodar |
|
Scientific Title of Study
|
An observational study to evaluate the relation between udara pramana (anthropometry measurement of abdomen) and jalodara |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Raj Rakholiya |
| Designation |
P G Scholar |
| Affiliation |
J.S.Ayurveda Mahavidhyalaya |
| Address |
Post Graduate Department of Rachana Sharira, J.S.Ayurveda Mahavidyalaya,College Road Nadiad. 387001
Kheda
Gujrat, india
Kheda
GUJARAT
387001
India |
| Phone |
7016630346 |
| Fax |
|
| Email |
rajrakholiya46@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seetharama Mithanthaya |
| Designation |
Professor |
| Affiliation |
J.S.Ayurveda Mahavidhyalaya |
| Address |
Post Graduate Department of Rachana Sharira, J.S.Ayurveda Mahavidyalaya,College Road Nadiad. 387001
Kheda
Gujrat, india
Kheda
GUJARAT
387001
India |
| Phone |
9901732256 |
| Fax |
|
| Email |
drsitharam1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Seetharama Mithanthaya |
| Designation |
Professor |
| Affiliation |
J.S.Ayurveda Mahavidhyalaya |
| Address |
Post Graduate Department of Rachana Sharira, J.S.Ayurveda Mahavidyalaya,College Road Nadiad. 387001
Kheda
Gujrat, india
GUJARAT
387001
India |
| Phone |
9901732256 |
| Fax |
|
| Email |
drsitharam1@gmail.com |
|
|
Source of Monetary or Material Support
|
| J.S.Ayurveda Mahavidyalaya & P.D. Patel Ayurveda Hospital, Nadiad, Dist - Kheda, State - GUjrat, India pin code - 387001 |
|
|
Primary Sponsor
|
| Name |
JSAyurveda Mahavidyalaya |
| Address |
J.S.Ayurveda Mahavidyalaya,College road,Nadiad, Dist - Kheda, State - Gujrat, India, Pin code 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 Raj Rakholiya |
J.S.Ayurveda Mahavidyalaya |
Post Graduate Department of Rachana Sharira, J.S.Ayurveda Mahavidyalaya,College Road Nadiad. 387001
Kheda
Gujrat, india
Kheda
GUJARAT |
7016630346
rajrakholiya46@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee MAM University- Nadiad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R188||Other ascites. Ayurveda Condition: JALODARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | Measurement of Udara | (Procedure Reference: NIL, Procedure details: Measurement will be done by help of measure tape. A first point will be marked on either side, five Angula lateral to umbilicus, and second point will be marked five Angula anterior to mid axillary line at the level of umbilicus on both the right and left side))
|
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Individuals of either gender ranging between 30 to 60 years of age.
2.The skin fold thickness in individuals body fat is less than 33 percentage in females 26 percentage in males
|
|
| ExclusionCriteria |
| Details |
1.Individual below 30 and above 60 years of age
2.Person with any abdominal surgery
3.Obesity
4.The skin fold thickness in individuals body fat is more than 33 percentage in females 26 percentage in males
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The proposed research work will help the physician to predict the prognosis of jalodar disease by measuring the udara pramana of patient. |
baseline (approx - 20 to 30 min) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/04/2024 |
| Date of Study Completion (India) |
25/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
In conclusion, Pramana Pariksa Serves as a low cost , non invasive, and culturally rooted diagnostic method that compelments modern clinical assessment |