OPD-based trial for Treatment adherence, tolerability and safety of Ayurveda therapeutic regimen in the management of Primary Knee Osteoarthritis

Treatment adherence, tolerability and safety of Ayurveda therapeutic regimen in the management of Primary Knee Osteoarthritis: An OPD-based study

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/07/054948

Enrollment

480

Registered

2023-07-07

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

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

Conditions

Health Condition 1: M170- Bilateral primary osteoarthritis of knee

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Pain in knee + Any three of the following 1. Age > 50 years 2. less than 30 minutes of stiffness 3. crepitus 4. bony tenderness 5. bony enlargement 6. no palpable warmth

Exclusion criteria

Exclusion criteria: 1. Grade 3 and above radiographic changes in the affected knee (Kellgren-Lawrence classification) 2. Significant trauma to the knee including arthroscopy within preceding one year 3. History of knee joint replacement 4. BMI more than equal to 30 kg per m² 5 History of prior intra-articular corticosteroid or hyaluronic acidadministration within one month of the study 6. Patient taking corticosteroids 7. Patient with history of Rheumatoid arthritis Psoriatic arthritis Psoriatic arthritis or any other type of inflammatory arthritis 8. history of hepatic disorders (more than three times upper normal limit of normal of liver enzymes) or renal disorders (serum creatinine more than 1.2 mg%) 9. History or active malignancy 10. Hypersensitivity to study interventions 11. Any other disease condition that in the opinion of the investigator may compromise the participants safety or compliance

Design outcomes

Primary

Measure	Time frame
Primary 1. Assessment of treatment adherence through self-reported compliance log and used medication containers/strips 2. Assessment of the tolerability of the Ayurveda therapeutic regimen through reported incidence of adverse events (GIT-related AE specifically) during the study period 3. Change in the laboratory safety parameters from baseline (CBC, LFT, KFT)Timepoint: 1. (Time frame: day 30, 60, 90, 120, 150, 180) 2. (Time frame: day 30, 60, 90, 120, 150, 180) 3. (Time frame: baseline, day 90, 180)	—

Measure

Time frame

Primary 1. Assessment of treatment adherence through self-reported compliance log and used medication containers/strips 2. Assessment of the tolerability of the Ayurveda therapeutic regimen through reported incidence of adverse events (GIT-related AE specifically) during the study period 3. Change in the laboratory safety parameters from baseline (CBC, LFT, KFT)Timepoint: 1. (Time frame: day 30, 60, 90, 120, 150, 180) 2. (Time frame: day 30, 60, 90, 120, 150, 180) 3. (Time frame: baseline, day 90, 180)

—

Secondary

Measure	Time frame
1. Change in WOMAC index score for pain, stiffness and physical function from baseline 2. Change in the score of Numeric Pain rating scale from baseline 3. Change in health related quality of life from baseline assessed through SF-12 questionnaire 4. Change in the need of Rescue Analgesic medication Timepoint: 1. Time frame: day 30, 60, 90, 120, 150, 180 2. Time frame: day 30, 60, 90, 120, 150, 180 3. Time frame: day 30, 60, 90, 120, 150, 180 4. Time frame: day 30, 60, 90, 120, 150, 180	—

Measure

Time frame

1. Change in WOMAC index score for pain, stiffness and physical function from baseline 2. Change in the score of Numeric Pain rating scale from baseline 3. Change in health related quality of life from baseline assessed through SF-12 questionnaire 4. Change in the need of Rescue Analgesic medication Timepoint: 1. Time frame: day 30, 60, 90, 120, 150, 180 2. Time frame: day 30, 60, 90, 120, 150, 180 3. Time frame: day 30, 60, 90, 120, 150, 180 4. Time frame: day 30, 60, 90, 120, 150, 180

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Countries

India

Contacts

Public ContactDr Milind Suryawanshi

Regional Ayurveda Research Institute

amhri-nagpur@gov.in8329875011

Outcome results