Safety evaluation of an antimalarial herbal product from Andrographis paniculata (AS201-01) in healthy volunteers.

Autor:	Widyawaruyanti A; Department of Pharmaceutical Sciences, Faculty of Pharmacy, Universitas Airlangga, Surabaya, Indonesia.; Center of Natural Product Medicine Research and Development, Institute of Tropical Disease, Universitas Airlangga, Surabaya, Indonesia., Jonosewojo A; Department of Health, Faculty of Vocational Studies, Universitas Airlangga, Surabaya, Indonesia., Ilmi H; Center of Natural Product Medicine Research and Development, Institute of Tropical Disease, Universitas Airlangga, Surabaya, Indonesia., Tumewu L; Center of Natural Product Medicine Research and Development, Institute of Tropical Disease, Universitas Airlangga, Surabaya, Indonesia., Imandiri A; Department of Health, Faculty of Vocational Studies, Universitas Airlangga, Surabaya, Indonesia., Widiastuti E; PT. Kimia Farma (Persero) Tbk, Bandung, Indonesia., Dachliyati L; PT. Kimia Farma (Persero) Tbk, Bandung, Indonesia., Budiman MF; PT. Kimia Farma (Persero) Tbk, Bandung, Indonesia., Setyawan D; Department of Pharmaceutical Sciences, Faculty of Pharmacy, Universitas Airlangga, Surabaya, Indonesia., Hafid AF; Department of Pharmaceutical Sciences, Faculty of Pharmacy, Universitas Airlangga, Surabaya, Indonesia.; Center of Natural Product Medicine Research and Development, Institute of Tropical Disease, Universitas Airlangga, Surabaya, Indonesia., Tantular IS; Center of Natural Product Medicine Research and Development, Institute of Tropical Disease, Universitas Airlangga, Surabaya, Indonesia.; Department of Parasitology, Faculty of Medicine, Universitas Airlangga, Surabaya, Indonesia.
Jazyk:	angličtina
Zdroj:	Journal of basic and clinical physiology and pharmacology [J Basic Clin Physiol Pharmacol] 2021 Jun 25; Vol. 34 (5), pp. 639-645. Date of Electronic Publication: 2021 Jun 25 (Print Publication: 2023).
DOI:	10.1515/jbcpp-2020-0381
Abstrakt:	Objectives: 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. Methods: 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. Results: 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. Conclusions: The outcome supports our previous observation that the AS201-01 tablet, given twice a day for 4 days, is safe and nontoxic. (© 2021 Walter de Gruyter GmbH, Berlin/Boston.)
Databáze:	MEDLINE
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