| CTRI Number |
CTRI/2026/02/103344 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
08/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding the process of Obesity through its causes in Obese individuals : An Ayurvedic Perspective |
|
Scientific Title of Study
|
Comparative Assessment of Etiological Factors of Vitiation of Rasavaha Srotas and Medovaha Srotas in Sthaulya (Obesity): A Case Control 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 |
Neeraj Joshi |
| Designation |
PG scholar |
| Affiliation |
Dr. D.Y. Patil College of Ayurved and Research Centre Pimpri Pune |
| Address |
Department of Ayurved Samhita and Siddhant, 4th floor, Dr D Y Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Pune
Pune MAHARASHTRA 411018 India |
| Phone |
8459727853 |
| Fax |
|
| Email |
ndjoshi0503@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Mrudula Joshi |
| Designation |
Professor Head of Department |
| Affiliation |
Dr. D.Y. Patil College of Ayurved and Research Centre Pimpri Pune |
| Address |
Department of Ayurved Samhita and Siddhant, 4th floor, Dr D Y Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Pune
Pune MAHARASHTRA 411018 India |
| Phone |
9226279270 |
| Fax |
|
| Email |
mrudula.joshi@dpu.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Vd Neeraj Joshi |
| Designation |
PG scholar |
| Affiliation |
Dr. D.Y. Patil College of Ayurved and Research Centre Pimpri Pune |
| Address |
Department of Ayurved Samhita and Siddhant, 4th floor, Dr. D.Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Pune
Pune MAHARASHTRA 411018 India |
| Phone |
8459727853 |
| Fax |
|
| Email |
ndjoshi0503@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D.Y. Patil College of Ayurved and Research Centre, Pimpri,Pune |
|
|
Primary Sponsor
|
| Name |
Vd. Neeraj Joshi |
| Address |
Dr. D.Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Pune Maharashtra, India 411018 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Vd Neeraj Joshi |
Dr. D.Y. Patil College of Ayurved and Research Centre |
OPD NO. 5 Of Kayachikitsa and OPD No. 7 of Swasthavritta, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Pune Maharashtra, India 411018 Pune MAHARASHTRA |
8459727853
ndjoshi0503@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. DYPCA & RC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E663||Overweight. Ayurveda Condition: ATISTHAULYAM (KEVALA-KAPHA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Case group -
BMI greater than or equal to 25 kg/m², Waist-Height ratio greater than 0.5 for both genders and having minimum three clinical features of Sthaulya.
Control group -
Individuals matched based on Age, sex and occupation having BMI between 18.5 to 24.9 kg/m² and Waist-Height ratio less than 0.5 |
|
| ExclusionCriteria |
| Details |
Individuals previously diagnosed with Secondary Obesity, Pregnant and Lactating women, Chronic Systemic Illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Identification of specific etiological factors in Sthaulya that are linked to the Rasavaha Srotas. |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Establishment of Rasavaha Srotas involvement in the Samprapti of Sthaulya. |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="182" Sample Size from India="182"
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)
|
01/04/2026 |
| 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="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
|
The observational study will be conducted on total of 182 participants using a questionnaire which will be prepared and validated at the beginning of the study. Participants will be enrolled based on the inclusion and exclusion criteria respectively. Collection of data will be done using the questionnaire through interview method. Data obtained will be then classified and tabulated for both the groups and appropriate statistical analysis will be done. The results obtained will then be used to come to a final conclusion of the study. |