| Autor: |
Widyawaruyanti, Aty, Jonosewojo, Arijanto, Ilmi, Hilkatul, Tumewu, Lidya, Imandiri, Ario, Widiastuti, Endang, Dachliyati, Lilis, Budiman, Muhammad F, Setyawan, Dwi, Hafid, Achmad F, Tantular, Indah S |
| Předmět: |
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| Zdroj: |
Journal of Basic & Clinical Physiology & Pharmacology; Sep2023, Vol. 34 Issue 5, p639-645, 7p |
| Abstrakt: |
Andrographis paniculata tablets (AS201-01) have previously been shown to have potent bioactivity as an antimalarial and to produce no unwanted side effects in animal models. Here, we present the phase 1 clinical trial conducted to evaluate the safety of AS201-01 tablets in healthy volunteers. The study was a randomized, double-blind controlled cross-over, a placebo-controlled design consisting of a 4-day treatment of AS201-01 tablets. A total of 30 healthy human volunteers (16 males and 14 females) were divided into two groups, and each group was given 4 tablets, twice daily for 4 days. Group 1 received AS201-01, while group 2 received placebo tablets. Volunteers were given a physical examination before the treatment. The effects of AS201-01 on random blood glucose, biochemical, and hematological as well as urine profiles were investigated. There were no changes in observed parameters as a result of AS201-01 being administered. Statistical analysis showed no significant difference (p>0.05) between the test and control group regarding hematology profile, biochemical profile, and random blood glucose. Increased appetite and better sleep, which categorized as grade 1 adverse event was reported after treatment with AS201-01 tablet The outcome supports our previous observation that the AS201-01 tablet, given twice a day for 4 days, is safe and nontoxic. [ABSTRACT FROM AUTHOR] |
| Databáze: |
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