| CTRI Number |
CTRI/2024/05/066826 [Registered on: 06/05/2024] Trial Registered Prospectively |
| Last Modified On: |
26/08/2025 |
| 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 12 rounds of slow and fast Suryanamaskara on gastric motility in overweight individuals |
|
Scientific Title of Study
|
Immediate effect of 12 rounds of slow and fast Suryanamaskara on gastric motility in overweight individuals: A comparative 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 |
Dr Laxman Prasad Sharma |
| Designation |
Post Graduate student |
| Affiliation |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
| Address |
Department of Post Graduate Studies Subharti College and Hospital of Naturopathy and Yogic Sciences,Swami Vivekanand Subharti University Subhartipuram, NH 58, Delhi Haridwar Bypass road
Meerut UTTAR PRADESH 250005 India |
| Phone |
7599868808 |
| Fax |
|
| Email |
ls99971234@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Nair Dhiren Ajit |
| Designation |
Assistant Professor and Post Graduate (PG) coordinator |
| Affiliation |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
| Address |
Department of Post Graduate Studies Subharti College and Hospital of Naturopathy and Yogic Sciences,Swami Vivekanand Subharti University Subhartipuram, NH 58, Delhi Haridwar Bypass road
Meerut UTTAR PRADESH 250005 India |
| Phone |
7899143619 |
| Fax |
|
| Email |
danny.a.nair@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Abhay M Shankaregowda |
| Designation |
Principal and Dean |
| Affiliation |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
| Address |
Department of Post Graduate Studies Subharti College and Hospital of Naturopathy and Yogic Sciences,Swami Vivekanand Subharti University Subhartipuram, NH 58, Delhi Haridwar Bypass road
Meerut UTTAR PRADESH 250005 India |
| Phone |
9639010531 |
| Fax |
|
| Email |
naturopathy@subharti.org |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR LAXMAN PRASAD SHARMA |
| Address |
Department of Post Graduate Studies Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences Swami Vivekanand Subharti University Subhartipuram, NH 58,Haridwar Bypass Road meerut Uttar Pradesh 250005 |
| 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 Laxman Prasad Sharma |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
Department of Post Graduate Studies,Subharti College and Hospital of Naturopathy and Yogic Sciences,Swami Vivekanand Subharti University Subhartipuram, NH 58, Delhi Haridwar Bypass road Meerut UTTAR PRADESH |
7599868808
ls99971234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics Committee (Medical) |
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 |
Fast pace Suryanamskara |
The participants will perform 12 rounds of Suryanamaskara in a rapid manner/ fast pace.
Number of rounds: 12
Duration of 1 round of suryanamaskara: 2 min
Duration of the entire practice: 24 min
|
| Comparator Agent |
Slow pace Suryanamaskara |
The participants will perform 12 rounds of Suryanamaskara in a slow manner/ slow pace.
Number of rounds: 12
Duration of 1 round of suryanamaskara: 6 min
Duration of the entire practice: 72 min
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. BMI: 25.00–29.99 kg/m2.
2. Willing to participate. |
|
| ExclusionCriteria |
| Details |
1. Pregnant women
2. Individuals who is being practicing yoga
3. subjects who have had significant surgery during the previous 12 months.
4. Obesity secondary to medication (ex. medicines for psychiatric disorders, epilepsy, Steroids, musculoskeletal disorders, osteoporosis) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Electrogastrogram |
Before and After Intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life Questionnaire |
Before & After Intervention |
|
|
Target Sample Size
|
Total Sample Size="130" Sample Size from India="130"
Final Enrollment numbers achieved (Total)= "130"
Final Enrollment numbers achieved (India)="130" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/05/2024 |
| Date of Study Completion (India) |
22/05/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Obesity is a condition characterized by an excessive amount of adipose tissue mass which can have negative effect on health. Since directly measuring fat mass is not commonly done in regular clinical settings, the Body mass index (BMI) is typically utilized as a substitute. According to the World Health Organization “obesity and overweight are classified as abnormal or excessive fat accumulation that is linked to an elevated risk of health, with overweight being defined as BMI >25 kg/m2 and obesity as BMI >30 kg/m2â€. BMI is determined by dividing weight by height squared (in kg/m2). Categories are identified by BMI for the general population: underweight (2)Five BMI < 18.5 kg/m2), normal weight (BMI 18.5-24.9 kg/m2), class I obesity (overweight; BMI 25.0-29.9 kg/m2), class II obesity (obesity; BMI 30.0-39.9 kg/m2), and class III obesity (severe obesity; BMI > 40 kg/m2). The National Family Health Survey (NFHS) reports that the prevalence of overweight or obesity in Indian men and women aged 15 to 49 has increased from 12.1% (NFHS-III) to 18.9% (NFHS-IV), and overall, among women it has climbed from 14.8% (NFHS-III) to 20.7% (NFHS-IV). In India, being overweight or obese is a serious health risk. Among the larger states, there were differences of more than 20% in the prevalence of overweight and obesity among men in Madhya Pradesh, Chhattisgarh, Maharashtra, Uttar Pradesh, and Odisha. Odisha, Gujarat, Nagaland, Maharashtra, Uttarakhand, Chhattisgarh, and Jharkhand have inter-division of more than 20% in the incidence of overweight/obesity among women. Therefore, approach which is cost effective and has no or minimum side effect is required. Complementary and alternative medicine (CAM) considered as one of the such treatment modality. The sequential yoga technique is known as the Suryanamaskara has been handed from the enlightened sages of the Vedic era. Here, the sun is called Surya in Sanskrit, while the word namaskar means "salutations". This ancient Indian practice involves making prayers to the rising Sun while facing east in the morning. It also involves a series of physical postures and controlled breathing exercises meant to provide a variety of mental, bodily, and spiritual advantages. Suryanamaskara is the exquisite fusion of twelve postures (Pranamasana, Hastautthanasana, Padahastasana, Ashwasanchalanasana, Parvatasana, Ashtanganamaskara, Bhujangasana) deliberate breathing, and relaxation. By practicing of yogasanas from series of Surya namaskar such as Bhujangasana, Padhastasana, Shashankasana enhances the intraabdominal pressure and strengthens the abdominal muscles. This relives gastric pressure and may show some physiological changes in gastric motility. Electrogastrography (EGG) records the myoelectric activity of the stomach (either the serosa or mucosa) that occurs before contractions and uses non-invasive cutaneous electrodes to identify sluggish gastric activity. The slow wave frequency, or the stomach electrical control activity (ECA), determines the periodicity of the sinusoidal impulses that are recorded by the Electrogastrogram (EGG). The frequency of stomach contractions is determined by the dominant Electrogastrogram frequency. The Electrogastrogram signals in humans reflect normal 3 cycles per minute (cpm).
gastric slow waves and, consequently, the slow wave frequency. This has been demonstrated by concurrently recording the gastric myoelectrical activity from either the serosa or mucosa, in addition to recordings from cutaneous electrodes. Bradygastria is the term for slow frequency (0–2.4 cpm), while tachygastria is the term for excessively high frequency (3.6–9.9 cpm)(35). The condition is characterized by recurrent nausea, vomiting, dyspepsia, stomach ulcers, cyclic vomiting syndrome, and other symptoms that point to irregular stomach emptying. A typical EGG suggests that the problem is most likely with the muscles or nerves controlling the stomach. Hence, current study is needed to explore the effectiveness of Suryanamaskara on Gastric mobility among overweight individuals and identify the physiological changes behind it which provide the scientific evidence which will be the first of its kind. |