curcuRouge® has succeeded in proofing a potential for treating human knee osteoarthritis, particularly at an early stage.
Title
Efficacy of High- and Low-Dose, Highly Bioavailable Curcumin (curcuRouge®) for Treating Knee Osteoarthritis: A Randomized, Double-Blind, Placebo-Controlled Prospective Study
Author
Yasuaki Nakagawa, Shigeru Yamada, Shogo Mukai, Kaori Akiyoshi, Yasuhiro Katsuura, Tadashi Hashimoto
Journal title
Clinical Medicine Insights Vol. 4 No. 3, 415-429 (2023)
Abstract
Purposes: To evaluate the clinical effects of orally administered curcuRouge® in patients with knee osteoarthritis (OA) after 12 weeks of treatment.
Methods: In this randomized, double-blind, placebo-controlled,
prospective clinical study. 90 patients over the age 40 with knee OA of Kellgren-Lawrence (KL) Grade Il or III were enrolled. A placebo or curcuRouge® containing 60 mg or 180 mg/day of curcumin was administered orally every day for 12 weeks. To monitor adverse events, blood biochemical analyses were performed before and after 12 weeks of each intervention. The patients knee symptoms were evaluated for 12 weeks using the Japanese Knee Osteoarthritis Measure (JKOM) criteria, a knee pain visual analog scale (VAS), the Japanese Orthopedic Association (JOA) knee scoring system, the need for nonsteroidal anti-inflammatory drugs (NSAIDs) and a timed up-and-go test (TUG).
Results: The declining trend in NSAIDs needs was significantly greater in high-dose curcuRouge® group than in placebo group. The decrease of highly sensitive CRP was significantly greater in high-dose of curcuRouge® than placebo group. In patients with KL Grade II, JOA and VAS scores improved significantly more in the high-dose curcuRouge® group than in the placebo group. We didn't find curcuRouge® related adverse event during the study period.
Conclusion: curcuRouge® has succeeded in proofing a potential for treating human knee OA, particularly at an early stage.
Study Outline
Type of Study:
Double Blind, Randomized, Placebo Controlled Study
Patients:
Medial knee osteoarthritis and KL classification Ⅱ / III
Arm :
High dose of curcuRouge; 90mg curcumin-containing capsule,2capsules/day
Low dose of curcuRouge; 30mg curcumin-containing capsule, 2capsules/day
Placebo; placebo capsule, 2capsules/day
Period of intake :
12 weeks
Number of patients:
30 patients/arm
Primary Outcome :
- Improve of JOA (Japanese Orthopedic Association score)
- Improve of JKOM (Japanese Knee Osteoarthritis Measure)
- Improve of VAS (Visual Analog Scale)
- Use of NSAIDs
In patients with KL Grade II, JOA score significantly improved from 0 to 12 weeks in the high-dose curcuRouge® group more than in the placebo group, while VAS knee pain score was significantly reduced.
On comparing the results at 12 weeks of treatment to those at 0 weeks, highly sensitive C-reactive protein (hs-CRP) levels significantly differed, with a greater reduction in the high-dose group than in the placebo group.
