| CTRI Number |
CTRI/2019/03/017909 [Registered on: 05/03/2019] Trial Registered Prospectively |
| Last Modified On: |
15/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A critical study on role of indiscipline in sleep to obesity |
|
Scientific Title of Study
|
A critical study on role of nidra viparyaya in sthaulya |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vikalp Pankajbhai Kubavat |
| Designation |
MD Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Department of Ayurved Samhita,
Parul Institute of Ayurved,
Parul University,
Limda, Waghodia,
Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9998258656 |
| Fax |
|
| Email |
Vikalp312@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Upasani |
| Designation |
Associate Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Department of Ayurved Samhita,
Parul Institute of Ayurved,
Parul University,
Limda, Waghodia,
Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9426779592 |
| Fax |
|
| Email |
Amit.upasani@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Vikalp Pankajbhai Kubavat |
| Designation |
MD Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Department of Ayurved Samhita,
Parul Institute of Ayurved,
Parul University,
Limda, Waghodia,
Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9998258656 |
| Fax |
|
| Email |
Vikalp312@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Parul Ayurved Hospital Vadodara |
| Address |
Parul Ayurved Hospital Limda Tal Waghodia DIst Vadodara |
| Type of Sponsor |
Other [Private Ayurved Medical College] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Vikalp Kubavat |
Parul Institute of Ayurved |
Parul Institute of Ayurved Limda Waghodia Vadodara
Vadodara
GUJARAT |
9998258656
vikalp312@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 |
| Patients |
(1) ICD-10 Condition: E65-E68||Overweight, obesity and other hyperalimentation, |
|
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Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Presence of Obesity i.e. Weight is more than 20% excess of the desirable weight accorign to Height sex and age ( according to annexed height and body weight table) over age adjusted BMI above 85th percentile (Asian Standard) |
|
| ExclusionCriteria |
| Details |
Obesity secondary to or associated with hyperthyroidism, Hypertention, DM, Hyperlipidemia, Cushings syndrome. Any concomitant serious disorder of the liver Kidneys, Heart, Lungs or other organs. Preganancy and Lactation. Person undergoing treatment for any other seroious illness |
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| Nidra Viparyaya has definate role in Sthaulya |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ratraujagarana has more impact on Sthaulya |
5 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/03/2019 |
| Date of Study Completion (India) |
30/04/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
In Ayurveda, Aahar (diet), Nidra (sleep) and Brahmacharya (celibacy) are the three main sub-pillars of life called as Trayopstambha. Nidra (sleep) has such inevitable effects on mind and body. Mounting evidence from laboratory studies with animals and humans suggests a mechanistic link between lack of sleep and increasing body weight.Prevalence of Sthaulya (obesity) has been increasing over the past few decades which may cause various complications. According to Ayurved, Nidra (sleep) and Aahar (diet) are the main causes for the Sthaulya (obesity). So this study is being carried to explore the relation of Nidra Viparyaya (sleep irregularity) i.e. Ratraujagarana, Diwaswap, AkalaNidrain the patients of Sthaulya (obesity). |