Treatment for knee joint Osteo Arthritis in Ayurveda

â??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 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/07/055131

Enrollment

480

Registered

2023-07-12

Start date

Unknown

Completion date

Unknown

Last updated

2023-07-25

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 Health Condition 2: M170- Bilateral primary osteoarthritis of knee

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1 American College of Rheumatology (ACR) functional status criteria class I, II and III 2 Able and willing to give informed consent

Exclusion criteria

Exclusion criteria: EXCLUSION CRITERIA Patients with the following criteria will be excluded from the study: Grade 3 and above radiographic changes in the affected knee (Kellgren-Lawrence classification) Significant trauma to the knee including arthroscopy within preceding one year History of knee joint replacement BMI>=30 kg/mÂ² History of prior intra-articular corticosteroid or hyaluronic acidadministration within one month of the study Patient taking corticosteroids Patient with history of Rheumatoid arthritis, Psoriatic arthritis, Psoriatic arthritis, or any other type of inflammatory arthritis History of hepatic disorders (more than three times upper normal limit of normal of liver enzymes) or renal disorders (serum creatinine > 1.2 mg%) History or active malignancy Hypersensitivity to study interventions Any other disease condition that in the opinion of the investigator may compromise the participantâ??s safety or compliance

Design outcomes

Primary

Measure	Time frame
1Assessment of treatment adherence through self-reported compliance log and used medication containers/strips 2Assessment of the tolerability of the Ayurveda therapeutic regimen through reported incidence of adverse events (GIT-related AE specifically) during the study period (Time frame: at 4 week, 8 week, 12 week, 16 week, 20 week, 24 week) 3Change in the laboratory safety parameters from baseline (CBC, LFT, KFT) (Time frame: at baseline, 12 week, 24 week Timepoint: 1Assessment of treatment adherence through self-reported compliance log and used medication containers/strips 2Assessment of the tolerability of the Ayurveda therapeutic regimen through reported incidence of adverse events (GIT-related AE specifically) during the study period (Time frame: at 4 week, 8 week, 12 week, 16 week, 20 week, 24 week) 3Change in the laboratory safety parameters from baseline (CBC, LFT, KFT) (Time frame: at baseline, 12 week, 24 week	—

Measure

Time frame

1Assessment of treatment adherence through self-reported compliance log and used medication containers/strips 2Assessment of the tolerability of the Ayurveda therapeutic regimen through reported incidence of adverse events (GIT-related AE specifically) during the study period (Time frame: at 4 week, 8 week, 12 week, 16 week, 20 week, 24 week) 3Change in the laboratory safety parameters from baseline (CBC, LFT, KFT) (Time frame: at baseline, 12 week, 24 week Timepoint: 1Assessment of treatment adherence through self-reported compliance log and used medication containers/strips 2Assessment of the tolerability of the Ayurveda therapeutic regimen through reported incidence of adverse events (GIT-related AE specifically) during the study period (Time frame: at 4 week, 8 week, 12 week, 16 week, 20 week, 24 week) 3Change in the laboratory safety parameters from baseline (CBC, LFT, KFT) (Time frame: at baseline, 12 week, 24 week

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Secondary

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

Measure

Time frame

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

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Countries

India

Contacts

Public ContactDrINDU P P

CCRAS, Ministry of Ayush GOI

dr.indupp@gmail.com9495312570

Outcome results