Evaluation of safety and efficacy of topical longan cream for pain relief associated with osteoarthritis of knee (symptomatic treatment of pain)
- Conditions
- Patients with OA knee following the American College of Rheumatology (ACR) and Kellgren-Lawrence grade between 2 and 3.Knee osteoarthritisLongan creamPain relief
- Registration Number
- TCTR20210326007
- Lead Sponsor
- Chulabhorn Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 170
1)Subjects who are Thai male or female, aged 50 to 80 years
2)Subjects who have a diagnosis with OA knee according to the American College of Rheumatology criteria (ACR).
3)Subjects who had a radiographically confirmed clinical diagnosis of Kellgren-Lawrence grade 2 and 3 at least 3 months prior to the screening visit.
4)Subjects whose visual analogue scale at the screening visit, is greater than or equal to 40 mm (in 100 mm VAS pain score)
5)Subjects whose baseline minimum joint space width (X-ray, MTP view) in the medial and lateral compartments of the index knee are more than 1.5 and 2.5 mm, respectively.
1)Female subjects who are pregnant or breast feeding.
2)Subjects who are with a history of hip or knee extremely surgery within 1 year prior to screening.
3)Subjects who have a history of acupuncture within 3 months of the study entry; intra-articular viscosupplementation (corticosteroid or hyaluronate injection) on the study knee within 6 months of screening.
4)Subjects who have any other painful or disable conditions affecting the waist or hip/back pain, or contralateral knee pain.
5)Subjects who have joint effusion at the study knee, abnormal accumulation of fluid around joint caused by serious infections and crystal-induced arthritis.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method