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Evaluation of safety and efficacy of topical longan cream for pain relief associated with osteoarthritis of knee (symptomatic treatment of pain)

Evaluation of safety and efficacy of topical longan cream for pain relief associated with osteoarthritis of knee (symptomatic treatment of pain)

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20210326007
Enrollment
170
Registered
2021-03-26
Start date
2021-05-03
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with OA knee following the American College of Rheumatology (ACR) and Kellgren-Lawrence grade between 2 and 3. Knee osteoarthritis Longan cream Pain relief

Interventions

85 patients will be randomized to receive topical longan cream and apply on the treated knee 3 times daily for 4 weeks. After a week of washout period, all participants in group A will be switched to
Experimental Drug,Experimental Drug
Group A,Group B

Sponsors

Chulabhorn Research Institute
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
primary efficacy outcome week 0,2,4,5 (each treatment) Visual Analog Scale (VAS) for pain score

Secondary

MeasureTime frame
secondary efficacy outcome week 0,2,4,5 (each treatment) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Countries

Thailand

Contacts

Public ContactJutamaad Satayavivad

Chulabhorn Research Institute

jutamaad@cri.or.th025538555

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026