| CTRI Number |
CTRI/2025/01/079421 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Yoga and Ayurveda : A Natural fix for knee pain and better performance |
|
Scientific Title of Study
|
Efficacy of integrated therapy (Yoga and Ayurveda) on clinical outcomes and Quality of life (QOL) among adults with Knee Osteoarthritis: A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yashwant Mishra |
| Designation |
PhD Scholar |
| Affiliation |
All India Institute Of Medical Science Rishikesh |
| Address |
Block A Level 6 Geriatric Medicine AIIMS Rishikesh, Dehradun, Uttarakhand
Dehradun
UTTARANCHAL
249203
India |
| Phone |
07777881904 |
| Fax |
|
| Email |
yashwantmishra219@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Minakshi Dhar |
| Designation |
Head Of Department Geriatric Medicine |
| Affiliation |
All India Institute Of Medical Science Rishikesh |
| Address |
Block A Level 6 Geriatric Medicine AIIMS Rishikesh, Dehradun, Uttarakhand
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7060002778 |
| Fax |
|
| Email |
minakshi.dhar@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sriloy Mohanty |
| Designation |
Senior medical officer Dept. of AYUSH |
| Affiliation |
All India Institute Of Medical Science Rishikesh |
| Address |
Department of AYUSH, AIIMS Rishikesh, Dehradun, Uttarakhand
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9560540977 |
| Fax |
|
| Email |
sriloy.smo.ayush@aiimsrishikesh.edu.in |
|
|
Source of Monetary or Material Support
|
| AIIMS RISHIKESH Veerbhadra marg, pashulok Rishikesh, 249203, Dehradun, Uttarakhand, India |
|
|
Primary Sponsor
|
| Name |
AIIMS Rishikesh |
| Address |
All India Institute Of Medical Science Rishikesh Pashulok Veerbhadra marg Rishikesh,249203 Dehradun Uttarakhand, India |
| 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 Minakshi Dhar |
AIIMS RISHIKESH |
Department Of Geriatric Medicine, Block A, Level 6, AIIMS Rishikesh Veerbhadra marg Pashulok, Rishikesh, Dehradun, Uttrakhand
Dehradun
UTTARANCHAL |
7060002778
minakshi.dhar@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS RISHIKESH |
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:M171||Unilateral primary osteoarthritisof knee. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | aBya~ggaH, अभ्यंग | (Procedure Reference: charakchiktsa 28/93, Procedure details: Abhyanga on Knees with Panchaguna Taila(20 ml) 15 min twice a day in a circular motion
)
(1) Medicine Name: Panchaguna taila, Reference: THE AYURVEDIC PHARMACOPOEIA OF INDIA Part 2 Vol 3, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: bd, Duration: 12 Weeks | | 2 | Comparator Arm (Non Ayurveda) | | - | active control arm | Provide physiotherapy tailored for OA among adults taken from HTA (Health Technology Assessment) Programme
Advised to do hot fomentation twice daily
Use topical NSAIDs (Diclofenac gel) after fomentation or whenever pain arises
Advise not to start any new therapy/medication without consulting the treating physician of AIIMS Rishikesh during the study period
| | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: panchtikta ghrit guggulu, Reference: THE AYURVEDIC PHARMACOPOEIA OF INDIA PART-II (FORMULATIONS) VOLUME-II, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: -luke warm water), Additional Information: -Along with this a integrated validated yoga module of 45 min will be taught and given to practice to the participants through online mode for 12 weeks which include sukshma-vyayam, asana, pranayama, meditation, and relaxation technique |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals aged more than 40 years,
2. Capacity to understand and follow yoga practice instructions.
3. Radiographic evidence of knee osteoarthritis Kellgren-Lawrence grade 2 or grade 3 on radiographs.
4. Persistent pain / Constant discomfort for 3 months before recruitment
5. Mild to moderate physical dysfunction (score more than 15 out of 68 on the physical function knee subscale of the Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC CRD- Pune version])
|
|
| ExclusionCriteria |
| Details |
1. Inability to participate in physical activity due to severe hearing or visual impairment, physical handicaps, fear of falling or balance issues, heart failure grade 4
2. Known cases of having active psychological illnesses
3. Above stage 3 renal disease.
4. Current involvement in additional Knee OA intervention.
5. Prolonged use of a knee brace, cane, walker, or wheelchair which may suggest instability.
6. Received corticosteroid and hyaluronic acid injections in the affected joint within three months of study admission.
7. Have had knee surgery/ knee arthroscopy or had a joint replacement before.
8. BMI more than 30
9. Knee pain caused by congenital dysplasia, rheumatoid arthritis, autoimmune diseases, and malignancies.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| After 12 weeks of intervention examine changes in knee osteoarthritis severity symptoms as measured by the change in knee disability score through the WOMAC CRD-PUNE VERSION Scale (The Western Ontario and McMaster Universities Osteoarthritis Index Score for Knee Joint) and KOOS score (Knee Injury and Osteoarthritis Outcome Score). |
0, 12 weeks; 6 and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in pain & difficulty performing daily activities after 12 weeks of treatment assessed using the WOMAC CRD PUNE VERSION subscale (physical function, pain)
|
0, 12 weeks, 6 & 12 months |
Change in psychological parameters (depression, anxiety, stress) through DASS score.
|
0,12 weeks, 6 & 12 months |
| Change in quality of life after twelve weeks of integrated Ayurveda & yoga therapy through SF-36. |
0, 12 weeks, 6 & 12 months |
|
|
Target Sample Size
|
Total Sample Size="162"
Sample Size from India="162"
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 |
|
Date of First Enrollment (India)
|
03/02/2025 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Knee Osteoarthritis (OA) is a prevalent degenerative joint disease with a global prevalence of 7.6%. It significantly contributes to the disease burden and medical expenses, impairs physical function, and reduces the quality of life (QOL) in adults.Treatment options include pharmacological, surgical, and non-pharmacological strategies, pharmacological intervention is mostly limited to pain relief whereas surgical interventions are considered an effective treatment option for advanced stages but their effectiveness comes at a significant health expenditure. Non-pharmacological strategies such as Yoga and Ayurveda, which are increasingly recognized as integrative medicine/therapy, are gaining attention due to their holistic and long-term benefits. Knee Osteoarthritis (OA) is a prevalent degenerative joint disease with a global prevalence of 7.6%. It significantly contributes to the disease burden and medical expenses, impairs physical function, and reduces the quality of life (QOL) in adults.Treatment options include pharmacological, surgical, and non-pharmacological strategies, pharmacological intervention is mostly limited to pain relief whereas surgical interventions are considered an effective treatment option for advanced stages but their effectiveness comes at a significant health expenditure. Non-pharmacological strategies such as Yoga and Ayurveda, which are increasingly recognized as integrative medicine/therapy, are gaining attention due to their holistic and long-term benefits. In this prospective trial, 162 participants aged more than 40 years diagnosed with knee OA following radiographic evidence (Kellgren-Lawrence grade 2 or grade 3) and mild to moderate physical dysfunction score (more than 20 out of 68 measured by WOMAC subscale CRD-Pune version) at baseline will be randomly assigned into two groups either the Yoga + Ayurveda group or the active control group with physiotherapeutic exercise & pharmacological intervention with an allocation ratio of 1:1 and followed for 12 months. Intervention arm- Yoga+Ayurveda Tablet of Panchatikta ghrita Guggulu (each 500 mg) 3 times a day after meals Abhyanga on Knees with Panchaguna Taila (20 ml) for 15 min twice a day Alongside a structured 45-min validated Yoga regimen via an online platform five days/week for 12 weeks. Comparator arm- Active Control arm •Physiotherapeutic exercise tailored for OA among adults will be provided which will include hot fomentation twice daily •The use topical NSAIDs (Diclofenac gel) after fomentation or whenever pain arises. Data will be collected at the end of the 12th week of therapy, and follow-up data will be collected at 6 and 12 months |