The Clinical Safety of Sahastara Remedy Ethanolic Extract
Capsules in Healthy Volunteers
Puritat Kanokkangsadal MSc1, Preecha Wanichsetakul MD2, Arunporn Itharat PhD1,3
Affiliation :
1 Department of Applied Thai Traditional Medicine, Faculty of Medicine, Thammasat University, Pathum Thani, Thailand
2 Department of Obstetrics and Gynecology, Faculty of Medicine, Thammasat University, Pathum Thani, Thailand
3 Center of Excellence in Applied Thai Traditional Medicine Research, Thammasat University, Pathum Thani, Thailand
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
signi(cid:976)icant different changing within group. There was also no signi(cid:976)icant difference between dose groups especially liver and renal
functions including AST, ALT, ALP, and creatinine (p>0.05). Although BUN show statistically signi(cid:976)icant difference between dose
group, it was not signi(cid:976)icantly 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-in(cid:976)lammatory, Quality control
All Articles
Download