| CTRI Number |
CTRI/2022/12/048232 [Registered on: 19/12/2022] Trial Registered Prospectively |
| Last Modified On: |
15/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ayurvedic medications in the treatment of Knee Osteoarthritris |
|
Scientific Title of Study
|
Efficacy of Rasnadi Guggulu with Maharasnadi Kwatha in Knee Osteoarthritis - A Randomized Controlled Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Oshin Sharma |
| Designation |
PG Scholar |
| Affiliation |
KAHERs Shri BMK Ayurved Mahavidyalaya Shahapur Belagavi |
| Address |
Dept of Kayachikitsa KAHERs Shri BMK Ayurved Mahavidyalaya Shahapur Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
7876082382 |
| Fax |
|
| Email |
oshinsharma1313@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Basavaraj R Tubaki |
| Designation |
Professor & Head of Department |
| Affiliation |
KAHERs Shri BMK Ayurved Mahavidyalaya Shahapur Belagavi |
| Address |
Dept of Kayachikitsa KAHERs Shri BMK Ayurved Mahavidyalaya Shahapur Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9448634660 |
| Fax |
|
| Email |
ayurbasavaraj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Basavaraj R Tubaki |
| Designation |
Professor & Head of Department |
| Affiliation |
KAHERs Shri BMK Ayurved Mahavidyalaya Shahapur Belagavi |
| Address |
Dept of Kayachikitsa KAHERs Shri BMK Ayurved Mahavidyalaya Shahapur Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9448634660 |
| Fax |
|
| Email |
ayurbasavaraj@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERs Shri BMK Ayurved Mahavidyalaya Shahapur Belagavi |
|
|
Primary Sponsor
|
| Name |
Dr Oshin Sharma |
| Address |
KAHERs Shri BMK Ayurved Mahavidyalaya Shahapur Belagavi |
| Type of Sponsor |
Other [Dr Oshin Sharma-Self sponsored PG Dissertation work] |
|
|
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 Oshin Sharma |
KLE Shri BMK Ayurveda Hospital and Research Centre Shahapur Belagavi |
KLE Shri BMK Ayurveda Hospital and Research Centre Shahapur Belagavi Dept of Kayachikitsa OPD 6 OPD 7
Belgaum
KARNATAKA |
7876082382
oshinsharma1313@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for research on human subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Rasnadi Guggulu, Reference: Yogaratnakar Vatavyadhirogadhikar, Chapter 25th, , Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: -(2) Medicine Name: Maharasnadi Kwatha, Reference: The Ayurvedic formulary of India, Part 1, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 10(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Shunthi Churna), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Tablet Etoricoxib | 1) Medicine name: Etoricoxib, NSAID, Route: Oral, Dose: 6o mg, Frequency: once a day, Time of administration: After food with water, Form: Tablet, Duration: 60 days |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Individuals aged between 40 years to 70 years
2 Subjects with Signs and Symptoms of Sandhigatavata as per Ayurvedic classics
3 Subjects fulfilling the diagnostic criteria & diagnosed previously (As per American college of Rheumatology (ACR) classification criteria for OA of the Knee)
4 Affected knee joint - Single or Both
5 Pain in the knee joints greater than or equal to 3 months
6 Patients of Either Sex
|
|
| ExclusionCriteria |
| Details |
1 Patients with Severe arthritis (KL grade IV)
2 Gross disability like bedridden and confined to wheel chair
3 Patients with RA, Gout, Osteoporosis and other Musculoskeletal system disorders
4 Patients with other major systematic disorders which interfere with the treatment will be excluded like uncontrolled DM (FBS>130 mg/dL, PPBS> 250 mg/dL, HbA1C> 8.5%) and Hypertension> 160/100 mm of Hg
5 Patients with ligamental or any other knee joint injury
6 Patients with history of Knee surgery
7 Use of NSAIDs, Analgesics, Intra articular steroid injections within the past period of 30 days.
8 Pregnant or lactating women
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome will be VAS and WOMAC Scale in Knee osteoarthritis in 60 days. |
Baseline, 15th, 30th, 45th and 60th day |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Secondary Outcome of Knee Osteoarthritis on the basis of WHOQOL-BREF Scale, Goniometry of Knee Joint, Walking Velocity & Interleukin-6 (IL-6) |
WHOQOL-BREF Scale – On Baseline, 15th, 30th, 45th, & 60th day
Goniometry of Knee Joint- On Baseline, 15th, 30th, 45th, & 60th day
Walking velocity- On Baseline, 15th, 30th, 45th, & 60th day
Interleukin 6 (IL-6)- On Baseline & 60th day |
|
Target Sample Size
Modification(s)
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/03/2023 |
| Date of Study Completion (India) |
08/04/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
08/04/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Osteoarthritis is the most common form of Arthritis and is a major cause of pain and disability in older people, affecting an estimated 302 million people Worldwide. The prevalence of Knee OA is more in India, Japan, China and African subcontinent. The prevalence rises progressively with age and is the most common joint disease with the prevalence of 22% to 39% in India. In this degenerative condition there will be pain, swelling and the movement of the joint is restricted. Thus, palliative management NSAIDs and Opioids are the mainstays of pharmacotherapy, even Knee Replacement is another option in managing Osteoarthritis. But all of these have some limitations with various adverse effects. Moreover, there are no proven disease-modifying therapies for osteoarthritis. Thus, Preventive measures previously addressed need to be reaffirmed throughout the world so that we will effectively reduce the future burden and disability of OA. Previous Ayurveda studies such as Panchakarma therapies and Shaman Aushadhi’s have shown some good results. For reducing pain, stiffness and inflammation Rasna is one of the best choices having such properties to combat this condition. Thus, Rasnadi Guggulu and Maharasnadi Kwatha are taken up for the study to see the effect on symptoms, Quality of life and IL-6 in knee osteoarthritis. Also, Considering the chronicity of the disease, a long-term safe and efficacious medication is required for the management. Thus, it is an attempt to see the effect of medication on Knee Osteoarthritis. |