| CTRI Number |
CTRI/2025/02/080088 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
07/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of chandranamaskar on
overweight and obesity |
|
Scientific Title of Study
|
Exploring the Effect Of Chandra Namaskar On Body
Composition Among Overweight And Obese
Individuals: A Randomized Controlled Trial
|
| 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 Nithya R |
| Designation |
PG Scholar |
| Affiliation |
International Institute of yoga and naturopathy medical sciences, Chengalpattu. |
| Address |
184/4, International Institute of yoga and naturopathy medical sciences, Department of Yoga, First floor, faculty block, Kamarajar nagar, Chengalpattu.
Kancheepuram TAMIL NADU 603001 India |
| Phone |
9994403365 |
| Fax |
|
| Email |
ramrajnithya96@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr A Gayathri |
| Designation |
Head of Department (Yoga) |
| Affiliation |
International Institute of yoga and naturopathy medical sciences, Chengalpattu. |
| Address |
184/4, International Institute of yoga and naturopathy medical sciences, Department of Yoga, First floor, faculty block, Kamarajar nagar, Chengalpattu.
Kancheepuram TAMIL NADU 603001 India |
| Phone |
8124634017 |
| Fax |
|
| Email |
gayathriannamalai93@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Nithya R |
| Designation |
PG Scholar |
| Affiliation |
International Institute of yoga and naturopathy medical sciences, Chengalpattu. |
| Address |
184/4, International Institute of yoga and naturopathy medical sciences, Department of Yoga, First floor, faculty block, Kamarajar nagar, Chengalpattu.
Kancheepuram TAMIL NADU 603001 India |
| Phone |
9994403365 |
| Fax |
|
| Email |
ramrajnithya96@gmail.com |
|
|
Source of Monetary or Material Support
|
| International Institute of yoga and naturopathy medical sciences, Chengalpattu,Tamilnadu,603001,India |
|
|
Primary Sponsor
|
| Name |
Dr Nithya R |
| Address |
184/4, International Institute of yoga and naturopathy medical sciences, Department of Yoga, First floor, faculty block, Kamarajar nagar, Chengalpattu. |
| 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 |
| Dr NITHYA R |
International Institute of Yoga and naturopathy Medical Sciences, Chengalpattu |
184/4, International Institute of yoga and naturopathy medical sciences, Department of Yoga, First floor, faculty block, Kamarajar nagar, Chengalpattu. Kancheepuram TAMIL NADU |
9994403365
ramrajnithya96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu, Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E663||Overweight, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Chandra namaskar |
Participants has to start with 5 rounds a day and by the end of the week it will be increased to
10 rounds a day. From second week onwards it will be 12 rounds of Chandra namaskar for 4 weeks. |
| Comparator Agent |
Lying in Shavasana |
Partcipants will lie down in supine lying with normal breathing for 30 mins for 4
weeks |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patients BMI ranging more than 25 and less than 35
Patients who are willing to participate in the study
No regular physical exercise and yoga |
|
| ExclusionCriteria |
| Details |
Person suffering from high blood pressure and cardiac issues
Persons who are taking any special diet, medicine or supplement for weight reduction
Women during pregnancy & lactation.
Individuals who have undergone recent abdominal surgery
Individuals with spinal deformity, sciatic, hernia, organ prolapse and slipped disc
Individuals who smoke and drink alcohol |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of Body stat 1500 |
Assessment of Body stat 1500 before and after the 4 Weeks Of intervention to overweight and obese individuals |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of Anthropometric measurements |
Assessment of Anthropometric measurements before & after the 4 Weeks of intervention to overweight & obese individuals |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/02/2025 |
| 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="1" Days="1" |
|
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - NIL
- For how long will this data be available start date provided 20-03-2026 and end date provided 21-04-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Obesity and overweight have become significant global health concerns, with both conditions associated with abnormal or excessive fat accumulation that can negatively impact health. The World Health Organization (WHO) has classified overweight and obesity as the fifth leading cause of death worldwide. The imbalance between energy intake and expenditure leads to these conditions, often assessed using Body Mass Index (BMI), where a BMI of 25-30 is considered overweight, and higher values categorize obesity into stages.
As of 2016, over one-third of people globally were overweight, and about 13% were obese. The rates of obesity and overweight have drastically increased since 1975, with a notable rise in both adult and adolescent obesity. By 2022, 16% of adults were obese, and 43% were overweight. Projections suggest these numbers will continue to rise in the coming years, particularly in countries like India.
Obesity is linked to various non-communicable diseases (NCDs), including osteoarthritis, diabetes, various cancers, and stroke. It also contributes to psychological issues like stress and sadness, which negatively affect overall well-being and quality of life.
Treatment for obesity includes anti-obesity drugs such as phentermine, orlistat, and liraglutide, among others. These medications aim to regulate weight over the long term, with orlistat often being the first choice due to its mechanism of action. In more severe cases, bariatric surgery may be recommended, though it comes with risks of complications both in the short and long term.
In addition to medical treatments, physical activity and yoga are valuable for weight management. Regular yoga practice can enhance strength, endurance, flexibility, and self-control. Chandra Namaskar, a form of yoga that reflects the moon’s phases, is a practice that may help reduce body weight and BMI. Preliminary research on the effects of Chandra Namaskar suggests it has positive outcomes on conditions like premenstrual syndrome (PMS) and adolescent aggression, though its impact on overweight and obese individuals has yet to be thoroughly studied. This research aims to explore whether Chandra Namaskar can have a beneficial effect on individuals dealing with obesity and overweight. |