Study of some herbal formulations in the management of Osteoarthritis Knee

Phase 2

Completed

• Conditions: Health Condition 1: M170- Bilateral primary osteoarthritis of kneeHealth Condition 2: null- Osteoarthritis Knee

• Registration Number: CTRI/2016/01/006552
• Lead Sponsor: Cental Council for Research in Ayurvedic Sciences

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: Completed
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

1.Patients of either sex aged between 35 and 65 years.

2.Patient of primary Osteoarthritis knee (Unilateral/ bilateral) as per at least three of following ACR clinical category of diagnostic criteria i.e.-

i)crepitus on active motion, (ii) < 30 minutes of morning stiffness, (iii) bony tenderness, (iv) bony enlargement, (v) no palpable warmth of synovium.

3.Radio graphical changes as per Grade I to III of Kellgren & Lawrence Radiological scale.

4.Able and willing to participate and provide signed informed consent.

Exclusion Criteria

a.Patients with Grade IV Kellgren & Lawrence Radiological scale

b.History of any trauma/ fractured joint / surgical/diagnostic intervention with reference to the affected joint(s).

c.Patients with co morbidities such as gouty arthritis, rheumatoid arthritis and psoriatic arthritis.

d.Patients having any deformity of knee hip or back altering the gait and posture of the patient.

e.Any unstable cardio-vascular diseases

f.Patients with diabetes mellitus HbA1C > 6.5%

g.Any other chronic systemic illness

h.Patients with evidence of malignancy.

i.History of knee arthroscopy/ knee replacement surgery

j.Patients with concurrent hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT) > 2 times upper normal limit or Renal Disorders (defined as S. creatinine > upper limit of Lab. value), Pulmonary Dysfunction (Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD])

k.The patient has been administered any chondoprotective drugs, intra-articular injection into the affected joint or systemic medication with corticosteroids during the preceding 3 months.

l.Pregnant / lactating woman.

m.Patient has an acute mental disorder

n.Patients who are currently participating in any other clinical trial.

Any other condition which the Principal Investigator thinks may jeopardize the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Any changes in Western Ontario and McMaster University osteoarthritis (WOMAC) total scoreTimepoint: 4th, 8th, 12th week