| CTRI Number |
CTRI/2025/03/083436 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Impact of Yoga on Salivary Cortisol Cardiovascular Risk Factors and Stress in Women With Type 2 Diabetes |
|
Scientific Title of Study
|
Efficacy of Yoga on Salivary Cortisol Cardiovascular Risk Factors and Stress in Women With Type 2 Diabetes 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 |
Maria Mazarrello A |
| Designation |
Lecturer |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research (DU) |
| Address |
Faculty Room 3rd Floor Department of Medical Surgical Nursing Sri Ramachandra Faculty of Nursing Sri Ramachandra Institute of Higher Education and Research Deemed to be University Porur Chennai 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9840186262 |
| Fax |
|
| Email |
mariamazarrello@sriramachandra.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Maria Mazarrello A |
| Designation |
Lecturer |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research (DU) |
| Address |
Faculty Room 3rd Floor Department of Medical Surgical Nursing Sri Ramachandra Faculty of Nursing, Sri Ramachandra Institute of Higher Education and Research Deemed to be University Porur Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9840186262 |
| Fax |
|
| Email |
mariamazarrello@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr RameshC |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research (DU) |
| Address |
Faculty Room 3rd Floor Department of Medical Surgical Nursing Sri Ramachandra Faculty of Nursing, Sri Ramachandra Institute of Higher Education and Research Deemed to be University Porur Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9880055512 |
| Fax |
|
| Email |
ramesh.c@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research Deemed to be University Porur Chennai Tamil Nadu India 600116 |
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute of Higher Education and Research DU |
| Address |
Sri Ramachandra Faculty of Nursing Sri Ramachandra Institute of Higher Education and Research Deemed to be University Porur Chennai Tamil Nadu India 600116 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrAdlyne Reena Asirvatham |
Sri Ramachandra Hospital |
Department of Endocrinology 2nd Floor Room No-19A
Chennai
TAMIL NADU |
98430 51977
adlynereena@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra Institute of Higher Education and Research (DU) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Routine care |
The control group will not receive yoga intervention They will receive only routine care |
| Intervention |
Yoga |
The researcher will conduct one-on-one yoga demonstrations at the Endocrine OPD of Sri Ramachandra Hospital during participants OPD visits. Each session will last 30 minutes and will include the following practices: Normal Breathing Exercises, Ardhakati Chakrasana, Padhasthasana, Salabhasana, Bhujangasana, Dhanurasana, Pavanamuktasana, Chin Mudra, Varuna Mudra, Sumana Mudra, Nadi Shuddhi, and Shanti Asana. Additionally, a yoga video demonstrating these practices will be shared with the participants to encourage regular practice at home over a period of three months |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
women with type 2 diabetes mellitus, HbA1c more than 8, Women or women’s family member those who use android based smart phones, Willing to participate in the study and Who are able to read English or Tamil language
|
|
| ExclusionCriteria |
| Details |
Who donot use android mobile phones, Patients with CAD, CVA, CKD, Liver Failure, Seizure disorder, Proliferative Retinopathy, Chronic DM more than 10 years and Patients on oral contraceptive pills |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| salivary cortisol, FBS, HbA1C, Creatinine, Glomerular Filtration Rate, FLP, Urine micro-Albumin, Blood pressure |
Pre-test- At the time of OPD visit
Post-test -After 3 months of pre test |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Stress, Quality of life |
Pre-test- At the time of OPD visit
Post-test I After one month of pre-test
Post-test II After two months of pre-test
Post-test III After three months of pre-test
|
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
03/04/2025 |
| 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="2"
Months="3"
Days="0" |
|
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 - NO
|
|
Brief Summary
|
| Purpose: Evaluate the efficacy of Yoga Intervention on Biomarkers, Cardiovascular Risk Factors, and quality of life in Women with Type 2 Diabetes Methods: The present study will adopt a randomized control trail design. 160 Women with Type 2 Diabetes (80 - study group) and (80 - control group) who met the inclusion criteria will be recruited using the Stratified Block Randomization technique. In this study, the study group received the yoga intervention in addition to routine care. Yoga demonstration includes Breathing Exercise, Ardhakati Chakrasana, Padhasthasanam, Salabasanam, Bhujangasanam, Dhanurasanam, Pavanamuktasanam, Chin Mudra, Varuna Mudra, Sumana Mudra, Nadisuddi, Shanthi Asana will be given one to one basis followed by Yoga video will be shared for doing at home. Providing reminder calls, follow up and receiving Feedback done through a mobile phone, Pamphlet Education also given about Diabetes Mellitus - definition, causes, signs and symptoms, complications, diet, lifestyle modifications, exercise, and follow-up. The participants in the control group will not receive yoga intervention and they will receive only pamphlet education and routine care. Pretest and post-test will be conducted for both study and control groups. The patients will be assessed for Biomarkers (Serum Cortisol, FBS, HbA1C, Creatinine, Glomerular Filtration Rate, FLP, Urine micro-Albumin. Antropometric measurements (Height, Weight, BMI, Waist Circumference, Hip Circumference, Waist Hip Ratio, Skin fold thickness, Body fat estimation, Blood pressure. Stress (Perceived stress scale). Quality of life (SF-36 Health scale for Quality of life). Proposed Results: The selected yoga poses and mudras will maintainSerum Cortisol, FBS, HbA1C, Creatinine, Glomerular Filtration Rate, FLP, Urine micro-Albumin effectively. Importantly very useful in maintaining adequate Weight, BMI, Blood pressure levels. Definitely it will have positive impact on reducing Stress and improving the Quality of life | |