| CTRI Number |
CTRI/2023/05/053248 [Registered on: 30/05/2023] Trial Registered Prospectively |
| Last Modified On: |
29/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Yogic Practices and foot massage in Elderly Subjects with Insomnia |
|
Scientific Title of Study
|
The Effect of Yogic Practices and Padabhyanga in Elderly Subjects with Insomnia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANINDYA SUNDAR CHOUDHURY |
| Designation |
PhD scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Swasthavritta and Yoga
Faculty of Ayurveda
Institute of Medical Science
Banaras Hindu University
Varanasi
Uttar Pradesh
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7872513797 |
| Fax |
|
| Email |
anindyasundar@bhu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mangalagowri V Rao |
| Designation |
Associate Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Swasthavritta and Yoga
Faculty of Ayurveda
Institute of Medical Science
Banaras Hindu University
Varanasi
Uttar Pradesh
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8178704037 |
| Fax |
|
| Email |
mangowri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mangalagowri V Rao |
| Designation |
Associate Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Swasthavritta and Yoga
Faculty of Ayurveda
Institute of Medical Science
Banaras Hindu University
Varanasi
Uttar Pradesh
UTTAR PRADESH
221005
India |
| Phone |
8178704037 |
| Fax |
|
| Email |
mangowri@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Banaras Hindu University |
| Address |
Department of Swasthavritta and Yoga Faculty of Ayurveda Institute of Medical Science Banaras Hindu University Varanasi Uttar Pradesh |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| ANINDYA SUNDAR CHOUDHURY |
Department of Swasthavritta and Yoga Faculty of Ayurveda Institute of Medical Science Banaras Hindu University Varanasi Uttar Pradesh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Anindya Sundar Choudhury |
Banaras Hindu University |
Department of Swasthavritta and Yoga Faculty of Ayurveda Institute of Medical Science Banaras Hindu University Varanasi Uttar Pradesh
Varanasi
UTTAR PRADESH |
7872513797
anindyasundar@bhu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Banaras Hindu University |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G470||Insomnia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Clonazepam 0.25-0.50 mg |
Medicine will be given before sleep on daily basis for 2 months. |
| Intervention |
Padabhyanga (foot massage) |
Foot massage will be given for 15 minutes per day for 5 days in a week for 2 months. |
| Intervention |
Yoga Intervention |
Yoga intervention including Loosening practices, Asanas (Standing, sitting, supine, prone posture), Pranayama, Meditation and closing prayer.
Yoga intervention for 5 days in a week for 50 minutes for 2 monthes. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having trouble in sleep and fulfillment of diagnostic criteria for insomnia disorder.
2. Patients having age > 60 to < 80 years.
3. No history of drug use or psychiatric disorder.
4. Absence of diseases of foot or foot deformity (corns, burning feet, amputation, skin diseases)
|
|
| ExclusionCriteria |
| Details |
1. Excessive use of alcohol, nicotine, or caffeinated beverages.
2. Various medical or neurological disorder
3. Other sleep disorders (eg. sleep apnoea, periodic limb movements) assessed through structured interview.
4. Patients having Chronic pain syndromes and other diseases affecting their sleep.
5. Patients suffering from Nocturia (frequent voiding during the night), which may be due to age-related physiologic changes and pathologies.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement of Subjective sleep quality, Sleep latency, Sleep duration, Sleep efficiency, Sleep disturbance, Use of sleep medication, Daytime dysfunction in elderly |
The efficacy of the therapy will be assessed at intervals of 15 days for duration of 2 months and 1 month after Completion of treatment or study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To asses the effects of yoga intervention and Improvement in the Geriatric depression scale(GDS)
2.To asses the effects of yoga intervention and Changing in daily living through Katz index,
3.To asses the effects of yoga intervention and quality of life through questionnaire EQ-5D-5L. |
Geriatric depression scale(GDS), Changing in daily living through Katz index, quality of life will be assessed before and after the trial of the two months. |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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 3 |
|
Date of First Enrollment (India)
|
15/06/2023 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Insomnia is a common medical problem among geriatric population. Numerous physical and mental health issues, including an increased risk for psychiatric disorders, suicide, and chronic illnesses like obesity, diabetes, cardiovascular disease, and chronic pain are linked to inadequate sleep and insomnia. So to provide better health we designed yoga module and try to find out the effects of yoga on insomnia among geriatric people besides we will find the effects of foot massage on insomnia people. Age group for this study is selected the range between 60 to 80 years old. For this study patients will be recruited from Swasthya Rakshana OPD, Geriatric OPD, Panchakarma OPD of Sir Sunder Lal Hospital and from camps by the department. Sbjective parameter of sleep will be asses through this study besides this Geriatric depression scale(GDS), Changing in daily living through Katz index, a self-assessed health related quality of life questionnaire EQ-5D-5L will be used in assessment criteria. |