Clinical Efficacy and Safety of Yellow Oil Formula 3 and 4 Versus Indomethacin Solution in Symptomatic Treatment of Osteoarthritis of Knee: A Randomized Controlled Study

Phase 2

Completed

• Conditions: Knee osteoarthritis , Mild to moderate knee pain

• Registration Number: TCTR20171219003
• Lead Sponsor: Department of Pharmacology, Faculty of Medicine, Chiang Mai University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-19
• Study Completion: 2018-10-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

a) An out patient aged 45 years
b) Unilateral or bilateral knee OA according to the criteria of ACR knee pain radiographic osteophytes and at least 1 of the following 3 items age 50 years morning stiffness not more than 30 minutes in duration or crepitus on motion The symptoms must be present for at least 3 months
c) VAS of knee pain between 35 75 point out of 100 after stopping using their usual analgesic or NSAIDs for at least 7 days
d) Able to walk and
e) must sign the written consent forms to participate in the study

Exclusion Criteria

a) Underlying inflammatory arthropathy such as rheumatoid arthritis and gout
b) Hyperuricemia uric acid 9 mg/dL
c) Plan to undergo surgery in near future
d) Recent injury in the knee affected by OA
e) History of intra articular corticosteroid injection within the last 3 months
f) Hypersensitivity to NSAIDs or herbs used in this study
g) Use of other NSAIDs or analgesic drugs
h) Acute OA attack inflammation edema redness warmth
i) Knee joint effusion
j) Continuing use of symptomatic slow acting drugs for OA SYSDOA e g glucosamine sulphate chondroitin sulphate diacerein and hyaluronan for less than 4 months or stop using these drugs for less than 6 months
k) Concomitant skin disease at the application site
l) Use of another topical product at the application site
m) Pregnancy or lactation
n) Malignant tumor or
o) Clinically significant abnormalities in blood chemistry and hematology
- Hemoglobin < 9 g/dL
- White blood cells < 4,000 per cu.mm.
- Platelets < 100,000 per cu. mm.
- Alanine aminotransferase ALT aspartate aminotransferase AST or alkaline phosphatase more than 2 times of the upper limit of normal
- Estimated glomerular filtration rate < 45 mL/min per 1.73 m2 as of the Chronic Kidney Disease Epidemiology Collaboration CKD EPI

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Responders at 4 weeks after starting the intervention Visual analog scale

Secondary Outcome Measures

Name	Time	Method
Knee symptoms and function at 0, 2 and 4 weeks after starting the intervention The knee injury and Osteoarthritis Outcome Score ,Stiffness at 2 and 4 weeks after starting the intervention Visual analog scale,Function at 0, 2 and 4 weeks after starting the intervention Time for climbing up 10 steps,Function at 0, 2 and 4 weeks after starting the intervention Time up and go,Adverse events at 2 and 4 weeks after starting the intervention Non-directive questioning and diary card