| CTRI Number |
CTRI/2024/06/069536 [Registered on: 26/06/2024] Trial Registered Prospectively |
| Last Modified On: |
02/08/2025 |
| 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
|
Uddiyana Bandha On Type 2 Diabetes Mellitus Patients |
|
Scientific Title of Study
|
Evaluating the effect of Uddiyana bandha on liver function and glucose tolerance in Type 2 Diabetes Mellitus 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 S Subhalakshmi |
| Designation |
Post-Graduate scholar |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences |
| Address |
184/4, International Institute of Yoga and Naturopathy Medical
Sciences, Faculty Block (Ground Floor), Department of Yoga,
Kamarajar Nagar, Chengalpattu
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9500596635 |
| Fax |
|
| Email |
subisiva000@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 |
| Address |
184/4, International Institute of Yoga and Naturopathy Medical Sciences, Faculty Block (Ground Floor), Department of Yoga,
Kamarajar Nagar, Chengalpattu
Kancheepuram
TAMIL NADU
603001
India
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
8124634017 |
| Fax |
|
| Email |
gayathriannamalai93@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Subhalakshmi |
| Designation |
Post-Graduate scholar |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences |
| Address |
184/4, International Institute of Yoga and Naturopathy Medical
Sciences, Faculty Block (Ground Floor), Department of Yoga,
Kamarajar Nagar, Chengalpattu.
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9500596635 |
| Fax |
|
| Email |
subisiva000@gmail.com |
|
|
Source of Monetary or Material Support
|
| International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu |
|
|
Primary Sponsor
|
| Name |
Dr S Subhalakshmi |
| Address |
184/4, International Institute of Yoga and Naturopathy Medical Sciences, Faculty Block (Ground Floor), Department of Yoga,
Kamarajar Nagar,
Chengalpattu,
Tamilnadu - 603001 |
| 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 S Subhalakshmi |
International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu |
184/4, International Institute of Yoga and Naturopathy Medical
Sciences, Faculty Block (Ground Floor), Department of Yoga,
Kamarajar Nagar, Chengalpattu
Kancheepuram
TAMIL NADU
603001
India
Kancheepuram
TAMIL NADU |
9500596635
subisiva000@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 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Shavasana |
The control group will rest in Shavasana which is performed by lying down in supine position with relaxed arms and legs for 15 minutes and the participants are allowed to continue their standard oral hypoglycaemic medication as received before the study. |
| Intervention |
Uddiyana Bandha |
The study group will receive Uddiyana bandha as an intervention and are allowed to continue their standard oral hypoglycaemic medications throughout the intervention period. Duration of yogic intervention will be 15 minutes per day for 4 weeks. They will receive one day of orientation program before the trial.The study group will receive 10 rounds of Uddiyana bandha and was asked to hold the position as long as comfortable, or a minimum of 1 to 2 s with a recovery time of 1 minute in between each round for around 15 minutes for a period of 4 weeks. For the practice of Uddiyana bandha, the patient should be in empty stomach and few preparatory practices are practiced for the first three days. The practice is withheld during menstruation period of the patient and continued afterwards.The patient was allowed to sit in any comfortable meditative asana like Padmasana or Bhadrasana by keeping the spine erect and the knees on the floor. If there is a discomfort the practice can be done in standing procedure. Inhale deeply through the nose, then exhale quickly through slightly pursed lips, but not forceful. Having fully exhaled, Jalandhara bandha is performed by moving the chin down to the chest and raising the shoulders. Then without much straining the abdomen is pulled upward and inward towards the spine. Hold for a few seconds or as long as possible. Before inhaling, relax the stomach and abdomen, release Jalandhara by raising the head, and sit straight. Practice eight to ten rounds, concentrating on the natural breath for a minute in between each round. Patient was allowed to rest in Shavasana if there is any discomfort while practicing. While practicing physical awareness should be on the abdomen and breath, and spiritual awareness should be on the Manipura chakra. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who are willing to participate in the study.
2. Type 2 Diabetes patients under simple oral hypoglycaemic drugs.
3. Patients who have Oral glucose tolerance more than 140 mg/dl or Fasting blood glucose more than 120 mg/dl.
4. BMI range between 20 to 35 Kg/m2
|
|
| ExclusionCriteria |
| Details |
1. Patients with Hypertension, Type 1 Diabetes, Diaphragmatic Hernia, Ulcer, Colitis, Cardiovascular diseases, Glaucoma, Acute infections, recent surgical history and other major abdominal and hepatic diseases (Liver cirrhosis, Hepatitis, Grade 2 and 3 Fatty Liver).
2. Patients who were regularly taking alcohol and other hepatotoxic drugs.
3. Women during pregnancy and lactation.
4. Patients who are not willing to participate in the study |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Liver Function Test and Oral Glucose Tolerance Test. |
Before and after the intervention on day one and at the end of four weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Waist circumference and Waist-hip ratio |
Before and after the intervention on day one and at the end of four weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
The term Diabetes
describes a group of metabolic disorders characterized and identified by the
presence of hyperglycemia in the absence of treatment. The multiple
etiopathology of Diabetes includes defects in insulin secretion, insulin
action, or both, and disturbances of carbohydrate, fat, and protein metabolism. The prevalence of Diabetes
was expected to increase from 415 to 642 million by 2040, with the most
significant increase in populations transitioning from low to middle-income
levels. The possible
pathophysiology of Diabetes is Insulin resistance which can be attributed to
excess fatty acids and proinflammatory cytokines, which leads to impaired
glucose transport and increased fat breakdown. Due to inadequate action or
production of insulin, there is an increase in glucagon, contributing to
hyperglycemia. Hyperglycemia alone can impair pancreatic beta-cell function and
impair insulin secretion. The liver plays a key
role in both glucose and lipid metabolism. Loss of insulin action in the liver
leads to glycogenolysis and an increase in hepatic glucose production. The
long-term storage of triglycerides caused hepatic oxidative stress resulting in
an imbalance between glutathione and oxidized equivalents (GSH/GSSH), impaired
mitochondrial energy production and dysfunctional β-oxidation of fatty acids. Gamma-glutamyl transferase has an
important role in glutathione homeostasis, considering the antioxidant activity
of glutathione, an increased level of gamma-glutamyl transferase may be linked
to oxidative stress which results in β cell dysfunction and glucose intolerance. High levels of serum alanine aminotransferase (ALT) and
gamma-glutamyltransferase (GGT) are associated with increased diabetes risk.Yoga originated in
India over 4,000 years ago as a traditional form of mind-body training that
helps to unite the individual self with the supreme self .
Uddiyana Bandha is a Sanskrit term that translates to ‘flying upward
lock,’ or ‘abdominal lock’ or ‘abdominal contraction’ and it refers to a
technique that involves a voluntary contraction of the diaphragm after
exhaling and pulling the abdominal muscles up and in towards their spine. According
to yoga philosophy, Uddiyana Bandha acts on the Manipura chakra and balances
the Samana and regulates the Antaragni or digestive fire. A study shows that
deep breathing, specific breath patterns, and the engagement of abdominal and
pelvic floor muscular locks (bandhas) may stimulate the vagus nerve, and
increase the parasympathetic activity. This induces a vacuum in the abdominal
cavity, which facilitates internal organ massage and enhances digestion.
Yoga has been demonstrated to help lower waist-hip ratio, triglyceride level,
proinflammatory cytokines and oxidative stress, which were the main
contributors to insulin resistance and β cell dysfunction in type 2 Diabetes
Mellitus.
Therefore, we hypothesize that Uddiyana bandha may reduce oxidative stress by
parasympathetic activity, increases blood flow to abdomen, reduces abdominal
fat deposition and gives a massaging effect to liver and pancreas by activating
the abdominal muscles which were beneficial in improving liver function and reducing
glucose intolerance in Diabetes.
Since there are very few studies on Uddiyana bandha and no specific
study on its impact on liver function and glucose tolerance, it is necessary to
justify the effect of Uddiyana bandha on metabolic function for bringing back
this ancient practice into modern day to day lifestyle which can help reduce the economic burden caused by non-communicable diseases like Diabetes.
Hence this study was planned to assess the effect of Uddiyana bandha on the
function of the liver and glucose tolerance in Type 2 Diabetes mellitus by
assessing the liver function and oral glucose tolerance |