Background: The Sahastara [SHT] remedy is a Thai traditional medicine which has long been used for muscle and joint pain treatment. The SHT remedy has potential to develop as modern drug in extract form. The clinical safety of SHT remedy extract need to be study as a part of phytomedicine development.

Objective: To investigate the clinical safety of capsules of SHT remedy ethanolic extracts in doses of 300 and 600 mg/day, in healthy volunteers.

Materials and Methods: Twenty-four eligible healthy volunteers were recruited into the study. They were divided into 2 groups (6 males and 6 females each group). They were required to take 1 or 2 capsules of 100 mg of SHT extract orally 3 times a day before meals for 28 days. The follow-up including history taking, complete physical examination, liver function test, and renal function test were performed every 14 days and continued for 14 days after the volunteers stopped taking SHT extract capsules.

Results: The SHT remedy extract capsules were quite safe to use in humans for 28 days. The results showed the most common adverse events of 600 and 300 dose groups were abdominal discomfort as 7 of 12 and 8 of 12, respectively. The severity was mild to moderate grade. The adverse events were relieved within 14 days after take medicine. Laboratory results showed no clinical significant different changing within group. There was also no significant difference between dose groups especially liver and renal functions including AST, ALT, ALP, and creatinine (p>0.05). Although BUN show statistically significant difference between dose group, it was not significantly changed in clinical consideration.

Conclusion: The SHT remedy extract capsules were safe to use in humans. There was no toxicity on liver or renal function and only mild systemic side effects. The 300 mg/day is the suggested dose to use in humans.

Keywords: Sahastara remedy, Safety, Anti-inflammatory, Quality control