| CTRI Number |
CTRI/2025/04/084480 [Registered on: 09/04/2025] Trial Registered Prospectively |
| Last Modified On: |
08/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Association of basic metabolic
rate with different body type in healthy person- A cross-sectional study |
|
Scientific Title of Study
|
Association of basal metabolic rate with different deha prakriti in healthy individual- A cross-sectional study |
| 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 Ramnarayan Tripathy |
| Designation |
PG Scholar |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Dept. of Kriya Sharira, Ayurvedic and Unani Tibbia College and Hospital, Ajmal Khan Rd, Block 56, Karol Bagh, New Delhi, Delhi
Ajmal Khan Rd, Block 56, Karol Bagh, New Delhi, Delhi
Central
DELHI
110005
India |
| Phone |
7682023773 |
| Fax |
|
| Email |
ramnarayanatripathy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr SK Panda |
| Designation |
Professor |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Dept. of Kriya Sharira, Ayurvedic and Unani Tibbia College and Hospital, Ajmal Khan Rd, Block 56, Karol Bagh, New Delhi, Delhi
Ajmal Khan Rd, Block 56, Karol Bagh, New Delhi, Delhi
Central
DELHI
110005
India |
| Phone |
9871553996 |
| Fax |
|
| Email |
drspanda79@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr SK Panda |
| Designation |
Professor |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Dept. of Kriya Sharira, Ayurvedic and Unani Tibbia College and Hospital, Ajmal Khan Rd, Block 56, Karol Bagh, New Delhi, Delhi
Ajmal Khan Rd, Block 56, Karol Bagh, New Delhi, Delhi
DELHI
110005
India |
| Phone |
9871553996 |
| Fax |
|
| Email |
drspanda79@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurvedic and Unani Tibbia College and Hospital, Karol Bagh, New Delhi -110005 |
|
|
Primary Sponsor
|
| Name |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Ayurvedic and Unani Tibbia College and Hospital,Ajmal khan road, block 56 Karol Bagh, New Delhi PIN-110005
New Delhi, Delhi, India |
| 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 Ramnarayan Tripathy |
Ayurvedic and Unani Tibbia College and Hospital |
Department of Kriya Sharir Ayurvedic and Unani Tibbia College and Hospital, Ajmal khan road, Block 56 Karol Bagh New Delhi Pin- 110005
Central
DELHI |
7682023773
ramnarayanatripathy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee (Ayurveda) AUTCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHY SUBJECTS |
|
|
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 |
Both |
| Details |
1.Subjects of age group between 18-40 yrs.
2.Subjects belonging to both of the genders.
3.Apparently healthy volunteers i.e, no history of serious illness or disease.
|
|
| ExclusionCriteria |
| Details |
1.Participants who are smoker, tobacco and alcohol consumer.
2.Participants suffering from any congenital anomalies or major physical disabilities.
3.Participants with any drug dependency.
4.DM, HTN, hypothyroidism, hyperthyroidism or any other serious systemic disorder.
5.Participants undergoing treatment for any major medical conditions
6.Pregnant or lactating females
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prakriti and BMR assessment as per validated tools and find out association between them. |
Prakriti assessment will be done on visit 1 (Baseline) and BMR will be assessed on visit 2 (Day 1). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
01/05/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
In modern era, there are many life style disorders occurring due to changes in environment, diet, lifestyle of an individual that affect the parameters of Quality of Life, thus degrading the life quality in population. Faulty diet habits lead to various disorders like heart diseases, CKD, liver diseases and other metabolic disorders. Due to inappropriate diet intake, there is alteration of digestive fire and metabolism, the patients tend to be obese and pathogenesis of various metabolic disorders occurs. Basal metabolic rate has significant role in body metabolism, increase or decrease in BMR leads to serious ailments in body. Therefore, it can play a vital role as an indicator of future diseases in the body. BMR and Prakriti are significantly related. This relation when established via suitable research, will be very much helpful for the prevalence, diagnosis, prognosis of disease and also in the planning of treatment modality, diet and lifestyle recommendations. • Diet and Metabolism: The prakriti can be used to determine the types of foods and dietary habits that are beneficial to an individual, while the BMR may indicate about the calorie requirement. • Lifestyle Recommendations: Understanding one’s prakriti can assist in adopting routines that align with the innate tendencies and impact the metabolism. • Health Objectives: By integrating the two concepts, the health objectives can be customized in a better way. |