Knee joint pain management through Ayurvedic Medicines

Phase 3

• Conditions: Health Condition 1: M179- Osteoarthritis of knee, unspecified

• Registration Number: CTRI/2021/07/034925
• Lead Sponsor: CCRAS New Delhi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Participant of any gender in the age group 40-65 yrs of Scheduled Caste community

2.Participant who are willing to provide written consent.

3.Participant of primary Osteoarthritis knee (Unilateral/ bilateral) as per any one of the following three ACR diagnostic criteria

1. Using history and physical examination

Pain in the Knee and 3 of the following:

i.Over 50 years of age.

ii. < 30 minutes of morning stiffness

iii.Crepitus on active motion

iv.Bony tenderness

v.Bony enlargement

vi.No palpable warmth

2. Using radiographic findings: (if available)

Pain in the Knee and 1 of the following:

i.Over 50 years of age.

ii. < 30 minutes of morning stiffness

iii.Crepitus on active motionand osteophytes.

3. Using history, physical examination and laboratory findings: (if available)

Pain in the Knee and 5 of the following:

i.Over 50 years of age.

ii. < 30 minutes of morning stiffness

iii.Crepitus on active motion

iv.Bony tenderness

v.Bony enlargement

vi.No palpable warmth of synovium

vii.ESR < 40mm/hour

viii.Rheumatoid Factor (RF) < 1:40

ix.Synovial fluid (SF) signs of osteoarthritis

Exclusion Criteria

i.Diagnosed cases of Rheumatoid arthritis or other type of inflammatory arthritis or patients who report to have been under anti-arthritic medication for RA or inflammatory arthritis.

ii.Participant prescribed Joint replacement surgery.

iii.Participant with history of trauma to the afflicted joint.

iv.Use of ambulatory aids such as wheel chair, walker etc

v.Someone who has BMI>=32kg/m² at the screening visit.

vi.Co-morbid conditions such as past history of Cardiac Arrhythmia, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.

vii.Known case of Renal/ Hepatic / Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease, Uncontrolled DM or HTN.

viii.Pregnant women/ women who are planning for conception and lactating women

ix.Patient taking participation in any other clinical trial.

x.Any other condition which the P.I. thinks may jeopardize the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified