| CTRI Number |
CTRI/2026/01/101258 [Registered on: 15/01/2026] Trial Registered Prospectively |
| Last Modified On: |
15/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect Of Nidanparivarjan Along With Dietary and Lifestyle Modification in Sthoulya in age Group 17 TO 40 Years Adults With Special Reference To Lipid Profile and BMI |
|
Scientific Title of Study
|
Observational Study On Effect Of Nidanparivarjan Along With Dietary and Lifestyle Modification in Sthoulya in age group 17 TO 40 Years Adults With Special Reference to Lipid Profile and BMI |
| Trial Acronym |
Sthoulya Nidan |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shital Mane |
| Designation |
Associate Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Ashta |
| Address |
Room No 11 Ground Floor Department Of Pathology Dhanvantari Hospital hHon Shri Annasaheb Dange Ayurved Medical College Ashta Taluka Walwa District Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
7507568054 |
| Fax |
|
| Email |
shital.shivrampawar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr GouriI Mohite |
| Designation |
Professor and HOD |
| Affiliation |
LRP Ayurvedic College And Research Center Urun Islampur |
| Address |
2nd Floor Department of Pathology LRP Ayurvedic Medical College And Research Center Urun Islampur
2nd Floor Department of Pathology LRP Ayurvedic Medical College And Research Center Urun Islampur
Sangli
MAHARASHTRA
415409
India |
| Phone |
8806073556 |
| Fax |
|
| Email |
mohitegouri2007@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gouri Mohite |
| Designation |
Professor and HOD |
| Affiliation |
LRP Ayurvedic College And Research Center Urun Islampur |
| Address |
2nd Floor Department of Pathology LRP Ayurvedic College And Research Center Urun Islampur
2nd Floor Department of Pathology LRP Ayurvedic College And Research Center Urun Islampur
Sangli
MAHARASHTRA
415409
India |
| Phone |
8806073556 |
| Fax |
|
| Email |
mohitegouri2007@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Shital Shankar Mane |
| Address |
Room No 11 Ground Floor Department of Pathology Dhanvantari Hospital Hon Shri Annasaheb Dange Ayurved Medical College Ashta 416301 Taluka Walwa District Sangli Maharashtra India |
| Type of Sponsor |
Other [] |
|
|
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 shital shankar mane |
Dhanvantari Hospital ADAMC Ashta |
Room No 11 Ground Floor Department of Pathology Dhanvantari Hospital ADAMC Ashta
Sangli
MAHARASHTRA |
7507568054
shital.shivrampawar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE REPORT |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E660||Obesity due to excess calories. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patient will be selected irrespective of gender occupation and habitat
Age group 17 to 40 years
BMI more than or equal to 25 kg per square metres to less than 40 kg per square metre
Patient presenting Lakshanas of Sthoulya with special reference to Obesity |
|
| ExclusionCriteria |
| Details |
Liver cirrhosis coronary heart disease renal diseases rheumatological disorders
hypothyroidism acute and chronic infection and major psychiatric illness
The current use of medicines such as insulin steroid hormones oral contraceptive
hormone replacement therapy and antipsychotic drugs
Patients not fulfilling inclusion criteria or Not agreed for giving consent or
investigations orfollow up
Age less than 17 years and greater than 40 years BMI less than 25 kg per square metres and greater than 40 kg per square metres
Obesity of hereditary or genetic origin or endocrinal involvement or due to any
secondary causes like long term steroid treatment etc
Cases suffering from major systemic disorders like cardiac diseases IHD
IDDM uncontrolled hypertension renal and hepatic diseases etc |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the effect of Nidanparivarjan along with dietary and lifestyle modification in Sthoulya
in age group 17 to 40 years adults with special reference to Lipid profile and BMI
AT BASELINE AND ON 30TH 60TH AND 90TH DAY |
AT BASELINE AND ON 30TH 60TH AND 90TH DAY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study correlation between BMI and Lipid Profile in Sthoulya in age group 17 to 40
years adults.
2. To study effect of Nidanparivarjan along with dietary and lifestyle modification in
Sthoulya in age group 17 to 40 years adults with special reference to BMI.
3. To study effect of Nidanparivarjan along with dietary and lifestyle modification in
Sthoulya in age group 17 to 40 years adults with special reference to Lipid profile.AT BASELINE AND ON 30TH 60TH AND 90TH DAY |
AT BASELINE AND ON 30TH 60TH AND 90TH DAY |
|
|
Target Sample Size
|
Total Sample Size="170"
Sample Size from India="170"
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)
|
30/01/2026 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
OBESITY IS ASSOCIATED WITH MANY PHYSIOLOGICAL AND BIOCHEMICAL ABNORMALITIES LIKE BMI AND LIPID PROFILE BEHAVIOR ACQUIRED DURING YOUNG ADULTHOOD OFTEN LASTS INTO ADULTHOOD THEREFORE THIS STAGE OF LIFE IS CONSIDERED IS A CRITICAL PERIOD TO INSTILL POSITIVE DIETARY AND HEALTH BEHAVIOUR TO PROMOTE OPTIMAL HEALTH. BY CONSIDERING ABOVE FACTORS THERE IS NEED OF STUDY WHICH ESTABLISHES RELATION BETWEEN STHOULYA AND BMI ALONG WITH LIPID PROFILE WHICH IS INTERVENED BY NIDANA PARIVARJANA ALONG WITH DIETARY AND LIFESTYLE MODIFICATIONS TO AVOID FURTHER COMPLICATIONS. |