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A double-blinded randomized clinical trial: Topical Sahasthara extract versus diclofenac for treating primary knee
Ninnart Intharit1, Arunporn Itharat1, Raimar Löbenberg2,3
1Department of Applied Thai Traditional Medicine and Center of Excellence in Applied Thai Traditional Medicine Research (CEATMR), Faculty of Medicine, Thammasat University (Rangsit campus), Klong Luang, Pathum Thani, 12120, Thailand.
Background And Aim:
Sahasthara (SHT), a traditional Thai herbal remedy used for anti-inflammatory and musculoskeletal disorders, lacks clinical evaluation as a topical formulation employing microemulsion (ME) technology. This study aimed to assess the efficacy and safety of a Sahasthara microemulsion (SHT-ME) compared with a diclofenac microemulsion (DF-ME) in patients with primary knee osteoarthritis (OA).
Experimental Procedure:
Eighty-four patients aged 40-70 years were randomized to receive either 1% SHT-ME or 2% DF-ME, applied three times daily for 28 days. Efficacy was evaluated using the pain visual analogue scale (VAS), 100-m walking time, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores, and global assessments. Safety assessments included physical examinations, laboratory tests, and adverse-event monitoring.
Results:
Both formulations significantly reduced VAS pain scores, improved walking time, and decreased WOMAC scores at days 14 and 28 compared with baseline (P < 0.05). No significant efficacy differences were observed between groups (P > 0.05). Liver and renal function, blood pressure, and biochemical parameters remained within normal ranges, and no severe or skin-related adverse events occurred in either group.
Conclusion:
SHT-ME provided efficacy comparable to DF-ME in relieving pain and improving mobility in knee OA. Both treatments were well tolerated and safe. These findings suggest that SHT-ME, a natural herbal alternative, and DF-ME, a synthetic drug formulation, are equally effective topical microemulsions for knee osteoarthritis management.