| CTRI Number |
CTRI/2024/03/063997 [Registered on: 12/03/2024] Trial Registered Prospectively |
| Last Modified On: |
03/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Structured Yoga Protocol and Structures Exercise Protocol] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARISON OF EXERCISE PROTOCOL & YOGA PROTOCOL IN THE MANAGEMENT OF KNEE OSTEOARTHRITIS AMONG THE ELDERLY POPULATION |
|
Scientific Title of Study
|
EFFECT OF EXERCISE PROTOCOL & YOGA PROTOCOL AS AN ADDON THERAPY IN THE MANAGEMENT OF KNEE OSTEOARTHRITIS AMONG THE ELDERLY POPULATION – A RANDOMIZED COMPARATIVE CLINICAL STUDY |
| 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 Naveen A M |
| Designation |
1st Year PG Scholar |
| Affiliation |
KAHERs Shri B M Kankanawadi Ayurved Mahavidyalaya and KLE Ayurved Hospital |
| Address |
OPD 2 OPD 7 and OPD 17
Department of Swasthavritta and Yoga
Department of Kayachikitsa
KAHERs Shri B M Kankanawadi Ayurved Mahavidyalaya and KLE Ayurved Hospital
Shahapur
Belagavi
Karnataka
Belgaum
KARNATAKA
590003
India |
| Phone |
9900911095 |
| Fax |
|
| Email |
naveen.b.a.m.s@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Patil |
| Designation |
Professor and HOD |
| Affiliation |
KAHERs Shri B M Kankanawadi Ayurved Mahavidyalaya and KLE Ayurved Hospital |
| Address |
OPD 2 and OPD 17
Department of Swasthavritta and Yoga
KAHERs Shri B M Kankanawadi Ayurved Mahavidyalaya and KLE Ayurved Hospital
Shahapur
Belagavi
Karnataka
Belgaum
KARNATAKA
590003
India |
| Phone |
9972583954 |
| Fax |
|
| Email |
ashokpatil.kaher@kleayurworld.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Patil |
| Designation |
Professor and HOD |
| Affiliation |
KAHERs Shri B M Kankanawadi Ayurved Mahavidyalaya and KLE Ayurved Hospital |
| Address |
OPD 2 and OPD 17
Department of Swasthavritta and Yoga
KAHERs Shri B M Kankanawadi Ayurved Mahavidyalaya and KLE Ayurved Hospital
Shahapur
Belagavi
Karnataka
KARNATAKA
590003
India |
| Phone |
9972583954 |
| Fax |
|
| Email |
ashokpatil.kaher@kleayurworld.edu.in |
|
|
Source of Monetary or Material Support
|
| KAHERs Shri B M Kankanawadi Ayurved Mahavidyalaya and KLE Ayurved Hospital |
|
|
Primary Sponsor
|
| Name |
KLE Academy of Higher Education and Research |
| Address |
KLE Academy of Higher Education and Research
JNMC Campus
Nehru Nagar
Belagavi
Karnataka |
| 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 |
| Dr Naveen A M |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya |
OPD 2 and OPD 17
Department of Swasthavritta and Yoga
OPD 7
Department of Kayachikitsa
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya
Shahapur
Belagavi
Karnataka
Belgaum
KARNATAKA |
9900911095
naveen.b.a.m.s@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Research on Human Subjects KLE Universitys Shri B M Kankanawadi Ayurved Mahavidyalaya and KLE Ayurved Hospital, Shahapur, Belagavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M170||Bilateral primary osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATAH, (2) ICD-10 Condition:M00-M99||Diseases of the musculoskeletal system and connective tissue. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Loosening exercises for 11 min
Yoga Postures for 23 min
Relaxation Technique 17 min
Pranayama 6 min, Pathya/Apathya:, Pathya:, Apathya: | | 2 | Comparator Arm (Non Ayurveda) | | - | Standard Knee Strengthening Exercise | Breathing Practice for 3 min
Loosening Exercise for 12 min
Knee Joint Exercise for 40 min |
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients who are fit to undergo Yoga protocol
2) Those with stable vitals (temperature, heart rate, pulse, respiratory rate etc.)
3) Subjects who are healthy yet have age-related mild functional diseases shall be included.
|
|
| ExclusionCriteria |
| Details |
(1) Any known malignancies.
(2) Known cases of Infectious diseases like tuberculosis etc.
(3) Known cases of Bronchial Asthma and other respiratory disorders.
(4) Age-related moderate to severe degenerative, functional, and cognitive disorders.
(5) Patient with RA, Traumatic Arthritis, Psoriatic Arthritis, and Gout Arthritis.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Yoga Protocol Therapy is effective in the reduction of knee joint pain in knee osteoarthritis patients. |
All participants will be assessed twice, at baseline on 1st day, and after 4 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| There are abrupt changes in the quality of Life in the elderly population with knee osteoarthritis by Yoga Therapy |
All participants will be assessed twice, at baseline on 1st day, & after 4 weeks. |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
15/04/2024 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 associated with multiple medical conditions mainly due to
deteriorating physiological reserves and impaired metabolic mechanisms.
Epidemiological aging studies report that non-communicable diseases such as
diabetes, arthritis, etc., are an integral part of aging, and were reported to
predict low-quality health-related QOL in older adults leading to a higher risk
of dependency. Epidemiological studies have reported a high prevalence of
Arthritis among adults aged 65 and older, and the report says that 22% to 39%
have been diagnosed with osteoarthritis. Osteoarthritis is prevalent more in
females than males, and the report says that 45% of women above 65 years have
osteoarthritis pain and 70% have been diagnosed with radiological findings.
Osteoarthritis is a chronic condition that has no effective treatment,
self-management is the only goal. The current study focuses on the comparative
effects of yoga-based intervention and physical therapy as an add-on to the
management of Knee Osteoarthritis and QOL in the elderly. |