DOI: 10.14457/tu.the.2020.842
title: Efficacy and safety of Sahastara remedy extract capsules in treating primary osteoarthritis of the knee compared with diclofenac (clinical trial phase II)

description: The Sahastara (SHT) remedy is a Thai traditional medicine for muscle pain relief. Active ingredients from SHT remedy were gallic aid, ellagic acid, plumbagin, piperine, and β asarone. However, there is little information on quality control of SHT remedy extract. The objective of this research was to develop a validated HPLC method for determination of markers in SHT remedy. HPLC chromatographic method was performed to assess the validation parameters by determination on specificity, limit of detection, limit of quantification, linearity, accuracy and precision. The developed method was shown to be linear (r2 &gt; 0.999), the peaks of gallic aid, ellagic acid, plumbagin, piperine, and β asarone were well separated with LOD = 3.12, 2.5, 0.78, 0.9, 2.5 µg/mL and LOQ = 6.25, 5, 1.56, 2.31, 5 µg/ml. The accuracy and precision were in acceptable range with good recovery. Total analysis time was approximately 61 min. The contents of gallic aid, ellagic acid, plumbagin, piperine, and β-asarone in SHT could be done in one analysis for the first time. By the conclusion, the present method is useful for routine quality control of Sahastara remedy ethanolic extract. Our previous study has shown that powdered SHT capsules effectively treated primary osteoarthritis. However, the patients had to take 6 x 500 mg capsules per day. The number of capsules taken could be reduced by using the SHT extract instead of powder. The purpose of this study was to investigate the efficacy and safety of SHT extract remedy for treating primary osteoarthritis (OA) of the knee.A double-blind, randomized, controlled phase 2 trial to examine the clinical safety of SHT compared with diclofenac in the treatment of osteoarthritis. Sixty-six patients, ages between 40 and 70 years of age, were randomly allocated into 2 groups. The SHT group received SHT extract capsules 100 mg three times daily, taken before meals, while the other group received diclofenac sodium 25 mg capsules 3 times daily after meals for 28 days. All patients were followed up on days 14 and 28 to assess efficacy and safety using clinical examination, blood test, visual analogue scale (VAS), and 100-meter walk test for improvement in quality of life. There were 32 and 31 patients in the SHT and diclofenac, clinical signs and symptoms, a complete physical examination, and assessments of kidney and liver function. Both drugs were shown to reduce VAS for symptoms. Diastolic and Systolic blood pressure slightly increased in the diclofenac group but the SHT group did not show any effect on blood pressure. The SHT remedy showed similar safety when compared with diclofenac in all evaluating symptoms of OA knee. However, the SHT remedy did not increase the values of AST, ALT and ALP which was increased in diclofenac treated group especially AST and ALT. Significant pain and 100 help significantly. Walk-meter test and WOMAC index score. However, there was no significant differences in the efficacy between the two groups. Conclusion, the SHT remedy ethanolic extract capsules at 300 mg/day was safe to use in primary osteoarthritis for 4 weeks with mild side effects. Oral administration was recommended after meals. The results of this study support the use of SHT extract in primary osteoarthritis knee.