| CTRI Number |
CTRI/2025/10/096616 [Registered on: 29/10/2025] Trial Registered Prospectively |
| Last Modified On: |
29/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
AN OBSERVATIONAL STUDY ON DIVASWAPNA AS HETU OF STHAULYA (OBESITY) |
|
Scientific Title of Study
|
An observational Study to assess DIVASWAPNA as Hetu of STHAULYA (OBESITY). |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neetu Chauhan |
| Designation |
MD Scholar |
| Affiliation |
Uttaranchal Ayurvedic College and hospital. |
| Address |
Department of Swasthavritta and yoga, Uttaranchal ayurvedic college and hospital,17 old Mussoorie Road Rajpur, Dehradun
Dehradun
UTTARANCHAL
248009
India |
| Phone |
8791497059 |
| Fax |
|
| Email |
neetuchauhan6161@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satya manav dayal |
| Designation |
Professor |
| Affiliation |
Uttranchal ayurvedic college and hospital |
| Address |
Department of Swasthavritta and yoga, Uttaranchal ayurvedic college and hospital,17 old Mussoorie Road Rajpur, Dehradun
Dehradun
UTTARANCHAL
248009
India |
| Phone |
9759396321 |
| Fax |
|
| Email |
Manav.7096@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Satya manav dayal |
| Designation |
Professor |
| Affiliation |
Uttranchal ayurvedic college and hospital |
| Address |
Department of Swasthavritta and yoga, Uttaranchal ayurvedic college and hospital,17 old Mussoorie Road Rajpur, Dehradun
Dehradun
UTTARANCHAL
248009
India |
| Phone |
9759396321 |
| Fax |
|
| Email |
Manav.7096@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Uttranchal ayurvedic college and hospital Dehradun |
| Address |
Uttranchal ayurvedic college and hospital 17 old Mussoorie Road Rajpur Dehradun,Uttarakhand |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Neetu chauhan |
Uttaranchal Ayurvedic College and hospital , 17 old Mussoorie Road Rajpur . |
Department of Swasthavritta and yoga,Uttaranchal Ayurvedic College and hospital, 17 old Mussoorie Road Rajpur.
Dehradun
UTTARANCHAL |
8791497059
neetuchauhan6161@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Obesity |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Individuals between age group of 20-50 years of either sex irrespective of their occupation and socio-economic status.
2.individuals having BMI more than 25 kg/m2.
3.individuals with informed consent to participate in the study
4.individual who were fully cooperative for study |
|
| ExclusionCriteria |
| Details |
1.individual not willing for the trial.
2.Pregnant and lactating mothers.
3. Night shift workers
4. Subject with cardiovascular disease, hypertension, diabetes, carcinoma any other serious illness.
5.Individual taking any medicine for sthaulya. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess Divaswapna as one of the hetus of sthaulya and relationship between Divaswapna and sthaulya using symptoms of sthaulya mention in Ayurveda classics and his/her anthropometric measurement . |
Who sleeps in day time and having BMI more than 25kg/m2.
6-12 months after day time sleeping regularly. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
11/12/2025 |
| 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 ayurveda,it is regarded as medoroga which includes fat tissue and fat metal, results fry the excessive accumulation of meda and mansa leading to flabbiness of hips, abdomen and breast.it is considered as santarpanottha vikar and counted one among the ashtnindita purusha by. Ayurvedic acharyas.now a day it can be seen that high-tech -machineries makes a person less active both in physical and mental level with ultimately leads in to sthaulya.among viharatmak nidana acharayas specially mentioned Divaswapna as causative factor of Sthaulya.so to find out its effect as a leading causative factor among the denizens this study is conducting. |