Safety and Efficacy of Sahasthara ME vs Diclofenac ME for Treating Primary Knee Osteoarthritis
Status:
Completed
Trial end date:
2021-12-08
Target enrollment:
Participant gender:
Summary
Background: Sahasthara is a traditional Thai herbal remedy used for the anti-inflammatory
treatment of the musculoskeletal system, while diclofenac sodium is one of the most topically
administered anti-inflammatory drug. However, there has not been scientifically researched
regarding the efficacy and safety of SHT formulated as ME.
Purpose: To assess the safety and effectiveness of Sahasthara microemulsion (SHT-ME) in
comparison to a diclofenac microemulsion (DF-ME) in treating primary osteoarthritis (OA) of
the knee.
Methods: A randomized, double blinded clinical trial phase II was conducted. One treatment
group received 1% SHT-ME, while the other received 2% DF-ME (2 ml, 3 times per day for 28
days) on their affected knee area. All patients were followed up at 14 and 28 days. Changes
in the visual analogue scale (VAS) for pain as well as 100-meter walking times, the WOMAC
index scores, and a global assessment were examined for efficacy. Clinical examinations,
abnormalities in laboratory tests, and the incidence of adverse events (AEs) were assessed
for safety.