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A Study to know the effectiveness of Janu Basti and Agni Karma in Knee Osteoarthritis Compared with a Locally Applied Analgesic

A Randomized Controlled, open-label, Parallel arm clinical study to assess the efficacy of Janu Basti and Agni karma Procedure in the management of Knee Osteoarthritis with a topical analgesic as control. - JAKOA Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/111163
Enrollment
105
Registered
2026-05-26
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M17- Osteoarthritis of knee

Interventions

None listed

Sponsors

Central Council for Research in Ayurvedic Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Individuals aged 50 to 65 years, previously or new, diagnosed with knee osteoarthritis (OA) using clinical and radiographic criteria of the American College of Rheumatology criteria. 2. Kellgren-Lawrence score of at least grade 2 in the knee X-ray images. 3. Written consent form. [ACR criteria for Diagnosis of Knee OA using history, physical examination and radiographic findings per Altman, R, et al.: Arthritis Rheum 34:505, 1991]

Exclusion criteria

Exclusion criteria: 1. Knee pain attributed to congenital dysplasia, rheumatoid arthritis, autoimmune diseases, malignancies, or prior knee surgeries/arthroscopy. 2. Recent administration of chondroprotective drugs, intra-articular injections into the affected knee, or systemic corticosteroids within the past three months. 3. Initiation of any new osteoarthritis (OA) treatment in the last four weeks, excluding over-the-counter analgesics like paracetamol or NSAIDs. 4. Presence of acute mental disorders, serious acute organic diseases, serious chronic comorbidities, or obesity at least at World Health Organization (WHO) grade II. 5. Blood coagulation disorders or use of coagulation-inhibiting medications (excluding acetylsalicylic acid and clopidogrel). Invasive joint procedureswithin the past 12 weeks or planned in the next 12 months. 6. Exclusion based on any severe comorbidity preventing participation in trial interventions (e.g., cardiac failure). 7. Pitta Prakriti (more than 60 percent pitta score on the Prakriti assessment scale).

Design outcomes

Primary

MeasureTime frame
Change in WOMAC scoreTimepoint: 0, 12th, 23nd, 30th, 45th day and 60th day

Secondary

MeasureTime frame
a. Net Promoter Score (NPS) Scale Rating, b. Patient Satisfaction Questionnaire (PSQ-18) Score. c. Use of OTC painkillers or NSAIDS d. Visual Analog Scale for Pain e. Any adverse events.Timepoint: a. Net Promoter Score (NPS) Scale Rating - 30th day b. Patient Satisfaction Questionnaire (PSQ-18) Score - 30th day c. Use of OTC painkillers or NSAIDS - 0, 12th, 23nd, 30th, 45th day and 60th day d. Visual Analog Scale for Pain - 0, 12th, 23nd, 30th, 45th day and 60th day e. Any adverse events - 12th, 23nd, 30th, 45th day and 60th day

Countries

India

Contacts

Public ContactDr Vikas Nariyal

CCRAS-RARI, Mandi

vikas.nariyal@gov.in9509560680

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026