| CTRI Number |
CTRI/2024/05/067481 [Registered on: 16/05/2024] Trial Registered Prospectively |
| Last Modified On: |
16/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Enhancing Well-being: Yogas Impact on Heart Health, Cognition, and Stress in Hypothyroid Patients |
|
Scientific Title of Study
|
Effect of Yogic Intervention on Heart Rate Variability, Cognition and Stress Parameters in Hypothyroid Patients: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 Shyoji Ram Yadav |
| Designation |
Postgraduate student in Physiology department, University college of medical Sciences, Delhi |
| Affiliation |
University College of Medical Sciences, Delhi |
| Address |
Department of Physiology UCMS and GTB Hospital Dilshad garden
Dilshad Garden, Delhi- 110095
North East
DELHI
110095
India |
| Phone |
7375824380 |
| Fax |
|
| Email |
drshyojiramyadav@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manish Gupta |
| Designation |
Professor |
| Affiliation |
University College of Medical Sciences, Delhi |
| Address |
Room No. 118, Department of Physiology UCMS and GTB Hospital Dilshad garden
Dilshad Garden, Delhi- 110095
North East
DELHI
110095
India |
| Phone |
9810571981 |
| Fax |
|
| Email |
manishdrucms@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shyoji Ram Yadav |
| Designation |
Postgraduate student in Physiology department, University college of medical Sciences, Delhi |
| Affiliation |
University College of Medical Sciences, Delhi |
| Address |
Department of Physiology UCMS and GTB Hospital Dilshad garden
Dilshad Garden, Delhi- 110095
North East
DELHI
110095
India |
| Phone |
7375824380 |
| Fax |
|
| Email |
drshyojiramyadav@gmail.com |
|
|
Source of Monetary or Material Support
|
| Principal, University college of Medical sciences, Delhi |
|
|
Primary Sponsor
|
| Name |
UCMS & GTB Hospital |
| Address |
UCMS & GTB Hospital, Dilshad Garden, Delhi- 110095 |
| Type of Sponsor |
Government medical college |
|
|
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 Shyoji Ram Yadav |
UCMS & GTB Hospital |
Room No. 115, Department of Physiology, Dilshad Garden, Delhi 110095
North East
DELHI |
7375824380
drshyojiramyadav@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE – HUMAN RESEARCH (IEC-HR) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E039||Hypothyroidism, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
Participants will be followed up
for 12 weeks. Conventional
treatment will continue. |
| Intervention |
Yogic Intervention |
Participants will practice Yogic
exercises for 12 weeks. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Hypothyroid patients between 20-45 years of age, on conventional treatment for at least three month and having TSH level above 10μIU/ml (normal range: 2.7-4.2μIU/ml). |
|
| ExclusionCriteria |
| Details |
1. Patients with previous history of cardiovascular disease/ any other acute or chronic pain/ endocrinal/ medical/ surgical/ psychiatry illness or any other illness.
2. Pregnant /Lactating women.
3. Patients already performing yoga, any other deep breathing exercises or any relaxation technique.
4. Patients consuming alcohol, drugs, doing smoking or any other substance addiction.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Changes in HRV.
2. Changes in Cognition score.
3. Changes in Stress parameters.
|
12 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Changes in Cognition score.
2. Changes in Stress parameters. |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
27/05/2024 |
| 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="5"
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
|
Study title: EFFECT OF YOGIC INTERVENTION ON HEART RATE VARIABILITY, COGNITION AND STRESS PARAMETERS IN HYPOTHYROID PATIENTS. Rationale: Hypothyroid patients had increased risk of coronary heart disease events, heart failure, and cardiovascular mortality among affected adults. Sympathovagal imbalance, cognitive impairment and higher stress have been reported in hypothyroid patients. Exploring the role of yogic intervention in hypothyroid patients on Heart rate variability, cognition and stress reduction can be helpful in the management of these patients. Aim: To assess the effect of yogic intervention on Heart Rate Variability, Cognition and Stress parameters in Hypothyroid Patients. OBJECTIVES: 1. To determine the effect of yogic intervention on Heart Rate Variability in hypothyroid patients. 2. To determine the effect of yogic intervention on Cognition through Cognition Self- Assessment Rating Scale (C-SARS) in hypothyroid patients. 3. To determine the effect of yogic intervention on Stress Parameters through Perceived Stress Scale (PSS) in hypothyroid patients. Study type: Prospective, Interventional Study Study design: Randomised Controlled Trial study Time frame: April 2024 to August 2025 Population /participants: Diagnosed Hypothyroid patients (TSH>10µIU) will be taken from Endocrinal OPD, Centre for Diabetes, Endocrinology & Metabolism, Delhi Sample size: 30 subjects in two groups (Total=60) Grouping of Subjects: Group I- Patients on conventional treatment and yogic intervention Group II- Patients on conventional treatment only Even on extensive search we could not find any article where the HRV and other parameters have been studied after yogic intervention in hypothyroid patients. Due to this paucity of literature we could not calculate the sample size, therefore a convenient sample of 30 subjects in group I and 30 subjects in group II will be taken in this study. The total 60 subjects will be randomized among two groups as per computer generated random number technique. Methods: Hypothyroid patients (TSH>10µIU) included in this study will undergo brief history taking, physical, clinical and anthropometric assessment prior to the participation. After the clinical evaluation is complete, hypothyroid patients who fulfil the inclusion & exclusion criteria and who sign the informed consent will be recruited for the study. Both groups will undergo HRV recording and assessment of cognition using the Cognition Self-Assessment Rating Scale (C-SARS) and Stress using the Perceived Stress Scale (PSS). Outcome measures: • Changes in HRV parameters. • Changes in cognition scores. • Changes in stress parameter. Statistical analysis: • Analysis will be done using SPSS 20.0 statistical software. • Between and within the group comparison will be done by unpaired and paired t-test. • P value of <0.05 will be considered significant. |