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Background and purpose: Andrographis paniculata (Burm.f.) Nees has been recommended to relieve symptoms and decrease the severity of COVID-19. The clinical study aimed to investigate the efficacy and safety of A. paniculata ethanolic extract (APE). Experimental approach: The efficacy and safety of APE in asymptomatic or mildly symptomatic COVID-19 patients compared with placebo were investigated through a prospective, double-blind randomized control trial. Patients received APE containing 60 mg of andrographolide, three times a day for five days. WHO progression scale, COVID-19 symptoms, and global assessment evaluated the efficacy and adverse events, liver and renal functions were monitored for safety. Findings/Results: 165 patients completed the study (83 patients in the APE group and 82 patients in the placebo group). The highest WHO progression scale was 4 and COVID-19 symptoms were significantly relieved on the last day of intervention in both groups, with no significant difference between groups. APE significantly relieved headache symptoms on day 1 and olfactory loss symptoms on day 2 compared to placebo. The global assessment showed that 80.7% of patients had total recovery after 5-day treatment with APE. Mild diarrhea was the most common side effect with a high dose that resolved within a few days. No hepatic or renal toxicity was associated with treatment. Conclusion and implications: APE at 180 mg/day for 5 days did not reduce COVID-19 progression in asymptomatic or mildly afflicted COVID-19 patients, however, it shortened the symptoms of olfactory loss with no adverse effects over 5 days of use.

Background and purpose: Sahastara (SHT) is a traditional Thai medicine for the treatment of musculoskeletal and joint pain. It consists of 21 plant components. A previous study demonstrated the anti-inflammatory activity of SHT on inhibition of nitric oxide production and prostaglandin E2 (PGE2) production, however, inhibitory effects on tumor necrosis factor-alpha (TNF-α) has not been reported. In this study, we evaluated the anti-inflammatory activity of SHT on inhibitory effects on TNF-α and PGE2 production and presented an analytical method for validation of SHT. Experimental approach: Anti-inflammatory activity was evaluated by inhibitory activity on TNF-α and PGE2 production in RAW264.7 cells. The validated procedure was conducted according to ICH guidelines. The validated parameters were specificity/selectivity, linearity, range, the limit of detection (LOD), and limit of quantitation (LOQ). Findings/Results: Ethanolic extract of SHT exerted inhibitory activity on PGE2 production in RAW264.7 cells with IC50 16.97 ± 1.16 μg/mL. Myristica frangrans seed extract showed the highest inhibitory activity on PGE2 production. Piper retrofractum extract showed the highest inhibitory activity on TNF-α production. For the HPLC method, all validated parameters complied with standard requirements. Each analyzed peak showed good selectivity with a baseline resolution greater than 1.51. The linearity of all compounds was > 0.999. The % recovery of all compounds was within 98.0-102.0%. The precision of all compounds was less than 2.0% CV. Conclusion and implications: Ethanolic extracts of SHT possess anti-inflammatory activity by inhibition of TNF-α and PGE2 production in vitro. This study provides support for the traditional use of SHT. The validated results showed good specificity/selectivity, linearity, precision, and accuracy with appropriate LOD and LOQ. This study is the first report on the validation of the HPLC method of SHT for use as quality control of the SHT extract.

Background and purpose: To investigate the pharmacokinetics of piperine after single oral doses of capsules containing Sahastara (SHT) remedy dried ethanolic extracts in healthy Thai volunteers. Experimental approach: Twenty-four healthy volunteers were divided into two dosage groups. They received a single oral dose of SHT remedy extract capsules of 100 or 200 mg. Blood was collected at time intervals of 0, 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 h. Acute clinical safety was monitored by complete physical examination and laboratory tests during the study period. Piperine concentration in blood and urine was determined by liquid chromatography tandem-mass spectrometry. Findings/Results: No serious adverse events were detected, only one volunteer had abdominal pain that was self-limiting. The pharmacokinetics of piperine following SHT remedy extract capsule administration demonstrated a mean peak concentration (Cmax) of piperine of 3.77 μg/mL and 6.59 μg/mL after dosing with 100 and 200 mg, respectively. Interestingly, a secondary maximum concentration of piperine was observed in this study, which might be related to enterohepatic recirculation. Negligible amounts of unchanged piperine were detected in urine. Conclusion and implication: The systemic exposure of piperine after SHT remedy ethanolic extract demonstrated dose proportionality after single oral dosing of 100-200 mg. Piperine was detectable in plasma for at least 48 h with evidence of enterohepatic recirculation. Metabolism and excretion profiles of piperine after administration of SHT remedy extract capsule need to be further explored for phytopharmaceutical product development.

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. [ABSTRACT FROM AUTHOR]

Introduction. The Sahastara (SHT) remedy is a Thai traditional medicine that has been acknowledged in the Thai National List of Essential Medicine and has been used as an alternative medicine to treat knee osteoarthritis. Although SHT remedies have been used in Thai traditional medical practices for a long period of time, there are few reports on their clinical trials. Aim of the Study. To investigate the clinical efficacy and safety of the SHT remedy in treating OA of the knee when compared to diclofenac. Methods. A phase 2, double-blind, randomized, and controlled trial study with a purpose to determine the clinical efficacy and safety of SHT in comparison with diclofenac for the treatment of knee osteoarthritis. Sixty-six patients, ages between 45 and 80 years of age, were randomly allocated into 2 groups. The SHT group received 1,000 mg of SHT powdered capsules 3 times per day, orally before meals, while another group received 25 mg of diclofenac sodium capsules 3 times a day, orally after meals for 28 days. All patients were followed up at 14 and 28 days for the evaluation of the efficacy and safety by using clinical examinations, blood tests, a visual analogue scale (VAS) for pain, and the 100-meter walktime test. Improvement on the quality of life was also assessed by the WOMAC index. Results. There were 31 and 30 patients in SHT and diclofenac groups, respectively, who had completed the study. Both medications have shown to significantly reduce the VAS for pain, and significantly improve the 100-meter walktime test and the WOMAC index score. However, there were no differences in the efficacy between the two groups. The blood chemistry showed no toxicity on renal and/or liver functions after taking SHT for 28 days but the patients who took diclofenac showed significant increases in their AST, ALT, and ALP. Systolic and diastolic blood pressure slightly increased in the diclofenac group but the SHT group did not effect on blood pressure. Conclusions. The SHT remedy is similar to diclofenac in all evaluating symptoms of OA knee. However, the SHT remedy has shown to be a good alternative treatment for OA knee with less systemic side effects when it was compared with diclofenac. [ABSTRACT FROM AUTHOR]