| CTRI Number |
CTRI/2025/11/098231 [Registered on: 28/11/2025] Trial Registered Prospectively |
| Last Modified On: |
26/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Body Type And Weight : How Metabolism Differs Across Individuals Of Overweight And Grade 1 Obesity |
|
Scientific Title of Study
|
A Study in Overweight And Obesity (Grade 1) Phenotypes Of Different Deha Prakriti To assess Metabolomic Variations For Risk Predictions And Precise Therapeutic Pathway : An Exploratory Observational And Bio Molecular 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 Akanksha Pundir |
| Designation |
MD Scholar |
| Affiliation |
All India Institute Of Ayurveda New Delhi |
| Address |
Room no 312 Department Of Kriya Sharira Academic block All India Institute Of Ayurveda Gautampuri Sarita Vihar Mathura Road New Delhi
South
DELHI
110076
India |
| Phone |
8890778854 |
| Fax |
|
| Email |
pundirakanksha79@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meera K Bhojani |
| Designation |
Additional Professor |
| Affiliation |
All India Institute Of Ayurveda New Delhi |
| Address |
Room no 302 Department Of Kriya Sharira Academic block All India Institute Of Ayurveda Gautampuri Sarita Vihar Mathura Road New Delhi
South
DELHI
110076
India |
| Phone |
9428570231 |
| Fax |
|
| Email |
ayumeerabhojani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akanksha Pundir |
| Designation |
MD Scholar |
| Affiliation |
All India Institute Of Ayurveda New Delhi |
| Address |
Room no 312 Department Of Kriya Sharira Academic block All India Institute Of Ayurveda Gautampuri Sarita Vihar Mathura Road New Delhi
South
DELHI
110076
India |
| Phone |
8890778854 |
| Fax |
|
| Email |
pundirakanksha79@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Ayurveda Gautampuri Sarita Vihar New Delhi 110076 |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Ayurveda New Delhi |
| Address |
All India Institute Of Ayurveda Gautampuri Sarita Vihar Mathura Road New Delhi 110076 |
| 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 Akanksha Pundir |
All India Institute Of Ayurveda |
Room no 312 Department Of Kriya Sharira, All India Institute Of Ayurveda New Delhi
South
DELHI |
8890778854
pundirakanksha79@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Overweight individuals |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Yava-Amalak Churna, Reference: Charak Samhita Sutrasthana 21/23, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: - |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Apparently overweight and obesity (Grade 1) individuals of age 18 to 40 years
irrespective of gender and occupation
BMI 23 to 24.9 kg per m² (overweight) and BMI 25 to 29.9 Obesity (Grade 1)
Any participant currently using weight loss medication or following any other weight
loss protocols of dieting should be included only after following a 3 week washout
protocol
However the patients habituated with exercise protocols maybe included
without wash out period
Individuals willing to give consent |
|
| ExclusionCriteria |
| Details |
Having any comorbid conditions viz. Diabetes Mellitus and Hypertension and cardiovascular diseases or major systemic illnesses
Participants with current use of weight-loss medications or following any other weight loss protocols of dieting if are not willing for the wash out period of 21 days maybe excluded Pregnant or lactating women.
• Any women participant with perimenopausal, menopausal or post menopausal symptoms.
• Allergy to any ingredients of Yava- Amalak Churna.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Identification of variations in metabolites & metabolomic pathways in overweight & obesity (Grade 1) individuals of different Deha Prakriti
2. Discovery of potential metabolic biomarkers for obesity risk prediction in over-weight & Obesity (Grade 1) individuals.
3. Generating evidence of differential metabolic pathways to Yava Amalak Churna across Prakriti groups in over-weight & Obesity (Grade 1) individuals
|
Metabolomic Assay will be performed after 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/01/2026 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Background: Obesity is a growing global health challenge, with significant variation in risk profiles and therapeutic responses. Ayurveda describes Deha Prakriti (individual constitutional types) as determinants of susceptibility to diseases and treatment outcomes. Modern metabolomics offers a tool to understand biochemical variations at a molecular level.
Aim: To explore the association between Deha Prakriti phenotypes and metabolomic variations in Grade-1 overweight and obese individuals, in order to predict disease risks and design precise therapeutic pathways.
Study Design:
Exploratory, observational study.
Participants: Adults with Grade-1 overweight/obesity.
Methods:
Assessment of Deha Prakriti (Ayurvedic constitution typing).
Phenotypic profiling of overweight/obesity.
Bio-molecular analysis using metabolomic techniques.
Correlation of molecular signatures with Prakriti types.
Expected Outcomes:
Identification of metabolomic markers associated with Deha Prakriti.
Early risk prediction for metabolic disorders in overweight and obesity.
Insights for personalized, Prakriti-based therapeutic strategies integrating Ayurveda and molecular biology.
Significance: This study bridges traditional Ayurvedic wisdom with modern biomolecular science, paving the way for personalized and predictive medicine in obesity management. |