| CTRI Number |
CTRI/2024/10/074665 [Registered on: 03/10/2024] Trial Registered Prospectively |
| Last Modified On: |
29/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical trial to study the effects of yoga and gastro hepatic pack in patients with type II diabetes mellitus |
|
Scientific Title of Study
|
The Effect of Yoga and Gastro Hepatic Pack on Type II Diabetes Mellitus: A Randomized Three Arm 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 Laimujam Preety Devi |
| Designation |
MD Scholar |
| Affiliation |
SDM College of Naturopathy and Yogic Sciences, Ujire, Karnataka |
| Address |
SDM College of Naturopathy and Yogic Sciences, Ujire, Karnataka
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9366535604 |
| Fax |
|
| Email |
laimujampreety9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Laimujam Preety Devi |
| Designation |
MD Scholar |
| Affiliation |
SDM College of Naturopathy and Yogic Sciences, Ujire, Karnataka |
| Address |
SDM College of Naturopathy and Yogic Sciences, Ujire, Karnataka
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9366535604 |
| Fax |
|
| Email |
laimujampreety9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ganesh Prasad |
| Designation |
Associate professor |
| Affiliation |
SDM College of Naturopathy and Yogic Sciences, Ujire, Karnataka |
| Address |
SDM College of Naturopathy and Yogic Sciences, Ujire, Karnataka
SDM College of Naturopathy and Yogic Sciences, Ujire, Karnataka
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9632608127 |
| Fax |
|
| Email |
gpbnys@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunetheshwara Yoga and Nature Cure Hospital, Shantivana, Dharmasthala, Belthangady, Dakshina Kannada, Karnataka, India - 574216 |
|
|
Primary Sponsor
|
| Name |
Dr. Laimujam Preety Devi |
| Address |
SDM College of Naturopathy and Yogic Sciences, Ujire, Belthangadi, Dakshina kannada, India - 574240 |
| 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 Laimujam Preety Devi |
SDM Yoga and Naturopathy College OPD |
Department of Yoga and Naturopathy, Ujire, Karnataka, India - 574240
Dakshina Kannada
KARNATAKA |
09366535604
laimujampreety9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, (3) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Yoga and Gastro hepatic pack |
Subject will undergo yoga practice for 40 mins and will receive a Gastro hepatic pack for 30 mins 5 days a week for a period of 3 months |
| Comparator Agent |
Yoga, Gastro hepatic pack, Yoga and Gastro hepatic pack |
Yoga- Subject will undergo Yoga practice for 40 mins for 5 days a week for a period of 3 months
Gastro hepatic pack - Subject will receive a gastro hepatic pack for 30 mins 5 days a week for a period of 3 months
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Type II Diabetes Mellitus - meeting the American Diabetic Association Diagnostic criteria and those who are on oral anti diabetic therapy.
2. Already diagnosed, at least 1 year
3. People who are willing to participant in the study |
|
| ExclusionCriteria |
| Details |
1.Type I Diabetes or Gestational Diabetes
2. Participants on insulin injection
3. Participant had recently undergone serious operations
4. Cardiac, renal and proliferative renal complication
5. Pregnancy
6. Patients who are sick and disabled |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Analysis of Glycated Haemoglobin : ADH has recommended HbA1c ≥ 6.5% for diagnosing diabetes
2.Fasting blood sugar : ≥ 126 mg/dL, no calorie intake for at least 8 hours
3.Postprandial plasma glucose : 2 hour ≥ 200 mg/dL |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Diabetes distress scale : a score is ≥3, then it is a high level of distress
2.Perceived stress scale : scoring ranging from
0-13 would be considered as low stress
14-26 would be considered moderate stres
27-40 would be considered high perceived stress |
3 months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/10/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
A category of metabolic illnesses known as diabetes are characterised by hyperglycemia brought on by deficiencies of insulin production, action or both. Diabetes persistent hyperglycemia is linked to long term harm, malfunction and failure of several organs. Many people with diabetes, especially type II DM in the early stages of the disease, do not exhibit any symptoms. However certain people with severe hyperglycemia particularly in children with total insulin shortage, may experience polyuria, polydipsia, polyphagia, weight loss and impaired vision. In India a prevalence of 77.0 million in 2016, 101.0 million by 2030 and 134.2 million by 2045. Diabetes related behavioural and emotional abnormalities are appertained to as diabetes related distress. Complications are the most significant complaint specific motorist of quality of life in people with diabetes and have been constantly demonstrated to prognosticate emotional distress in similar people. The measure of perceived stress is not the quantity of stressful events that occur in a person’s life, but rather the individual’s perception of the overall stress of their life and their ability to manage it. Yoga, an Indian practice, is beneficial to balance metabolism by lessening the damaging effects of stress and calming down the HPA axis and sympathoadrenal activation and enhanced insulin sensitivity at target tissues. The Gastro hepatic pack, a naturopathic treatment, can improved diabetes distress, perceived stress and glucose levels. However, more studies are needed to validate the effects of yoga and GH pack on Type II DM. This study focuses on their impact on patient with Type II Diabetes Mellitus. |