| CTRI Number |
CTRI/2025/03/083168 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
24/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of yoga in stress |
|
Scientific Title of Study
|
Effect of selected yoga techniques in reducing stress among the age group 60-75 years |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ATHIRA R NAIR |
| Designation |
Pg scholar |
| Affiliation |
Government Ayurveda College, Trivandrum |
| Address |
Government ayurveda college, Thiruvananthapuram
Department of swasthavritta, op no 2
Government Ayurveda college panchakarma hospital
Poojappura
Thiruvananthapuram
KERALA
695012
India |
| Phone |
9544075521 |
| Fax |
|
| Email |
athirapalamel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ATHIRA R NAIR |
| Designation |
Pg scholar |
| Affiliation |
Government Ayurveda College, Trivandrum |
| Address |
Government ayurveda college, Thiruvananthapuram
Department of swasthavritta, op no 2
Government Ayurveda college panchakarma hospital
Poojappura
Thiruvananthapuram
KERALA
695012
India |
| Phone |
9544075521 |
| Fax |
|
| Email |
athirapalamel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Smitha Mary shine |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurveda College, Trivandrum |
| Address |
Government ayurveda college, Thiruvananthapuram
Department of swasthavritta, op no 2
Government Ayurveda college,panchakarma hospital
Poojappura
Thiruvananthapuram
KERALA
695012
India |
| Phone |
9446315549 |
| Fax |
|
| Email |
smithamaryshine@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| GOVERNMENT AYURVEDA COLLEGE
PANCHAKARMA HOSPITAL
POOJAPPURA
THIRUVANANTHAPURAM
695012
Kerala
India |
|
|
Primary Sponsor
|
| Name |
Athira R Nair |
| Address |
Pg scolar, Government Ayurveda college, Trivandrum
Department of Swasthavritta
Op no 2
Government ayurveda college Panchakarma hospital
Poojappura |
| 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 |
| Athira R nair |
Government Ayurveda college, Trivandrum |
Department of swasthavritta op no 2
Government ayurveda college panchakarma hospital, poojappura,
Thiruvananthapuram
KERALA |
9544075521
athirapalamel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE(IEC),Gov t ayurveda college,Thiru vanathapuram,Kerala,India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F439||Reaction to severe stress, unspecified. Ayurveda Condition: MANA-SANTAPAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Yogasanas , Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants having mild and moderate stress.
2. Participants aged between 60-75 years irrespective of gender.
3. Participants who are willing to do yoga.
|
|
| ExclusionCriteria |
| Details |
1. Participants having diagnosed psychiatric illness
2. Participants having diagnosed malignancies.
3. Participants having diagnosed debilitating diseases.
4. Participants having diagnosed severe neuromuscular diseases.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| By changes in stress scores (Annexure2-Perceived Stress Scale) before and after yoga intervention. |
After 45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
10/04/2025 |
| 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="1"
Months="6"
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
|
Ageing is a normal phenomenon which is inevitable and in India , the size of elderly population is fast growing although it constituted among 7.4 % as per 2001 census.Among the states the proportion varies from around 4% in states like Nagaland, Meghalaya etc to more than 10.5% in Kerala. Population aging is humanities greatest triumphs. The diseases of locomotor system cause more discomfort and disability than any other chronic disease in the elderly. Stress is another problem people face in old age.Elderly people are highly prone to mental morbidities due to ageing of the brain, problems associated with physical health, cerebral pathology, socio-economic factors such as breakdown of the family support systems, and decrease in economic independence. The mental disorders that are frequently encountered include dementia and mood disorders. Other disorders include neurotic and personality disorders, drug and alcohol abuse, delirium, and mental psychosis,With regard to rising public expenditure for medical care, available data increasingly indicate that old age itself is not associated with increased medical spending, rather it is disability and poor health often associated with old age that are costly.Yoga is one of the most useful and cost effective methods of inducing a healthy and active life while at the same time preparing for spiritual awakening. The objective of the study is to assess the effect ofselected yoga techniques, in reducing stress among geriatric population.Yoga is good at addressing individuals at physical, psycological. and social levels.Relaxation induced by meditation helps to stabilize the autoimmune system. It also helps to relieve the stress and corrects numerous psychosomatic conditions prevalent in old age. Individuals of both sex, aged 60-75 years registered in the out -patient department of Swasthavritha is selected. Individuals who are not fit for doing yoga , those who are having malignancies and those who are not wiling to do yoga are excluded.Each session will start and end with prayer. Beginners will start with loosening exercises. Each asana will be done 2 rounds in first week and 5 rounds in coming weeks. Relaxation in shavasana will be given after completing the yogasanans. Asanas that are done are padahastasana ,Balasana,Marjariasana, shithiladandasana, pashchimothasana, Sukhasana,and Shavasana. Nadishuddhi pranayama, Sheethali Pranayama, sheetkari pranayama and Bhramari pranayama will be done after completing the asanas. Instant relaxation techniques will be practiced in shavasana. The total duration will be for 60 minutes and will be done for a period 45 days.Stress scores before and after the study will be assessed through appropriate tools.(Perceived stress scale).
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