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

Aty Widyawaruyanti; Arijanto Jonosewojo; Hilkatul Ilmi; Lidya Tumewu; Ario Imandiri; Endang Widiastuti; Lilis Dachliyati; Muhammad F Budiman; Dwi Setyawan; Achmad F Hafid; Indah S Tantular

doi:10.1515/jbcpp-2020-0381

Article

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

Aty Widyawaruyanti , Arijanto Jonosewojo , Hilkatul Ilmi , Lidya Tumewu , Ario Imandiri , Endang Widiastuti , Lilis Dachliyati , Muhammad F Budiman , Dwi Setyawan , Achmad F Hafid and Indah S Tantular

Published/Copyright: June 25, 2021

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From the journal Journal of Basic and Clinical Physiology and Pharmacology Volume 34 Issue 5

Abstract

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.

Keywords: Andrographis paniculata ; clinical trial; healthy volunteers; herbal tablets; safety

Corresponding author: Aty Widyawaruyanti, Department of Pharmaceutical Sciences, Faculty of Pharmacy, Universitas Airlangga, Surabaya, Indonesia; and Institute of Tropical Disease, Universitas Airlangga, Surabaya, Indonesia, E-mail: aty-w@ff.unair.ac.id

Acknowledgments

The authors are grateful to the volunteers who participated in this study.

Research funding: This research was funded by the Directorate General of Research Technology and Higher Education (DGHE) through Penelitian Unggulan Strategis Nasional (PUSNAS) with contract No. 597/UN3.14/LT/2017.
Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
Competing interests: The authors declare that there are no conflicts of interest in this study.
Ethical approval: The study protocol was approved by the Ethical Committee of Health Research, Faculty of Medicine, Universitas Airlangga No: 182/EC/KEPK/FKUA/2016.

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Received: 2020-11-17

Accepted: 2021-06-09

Published Online: 2021-06-25

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Articles in the same Issue

https://doi.org/10.1515/jbcpp-2020-0381

Keywords for this article

Andrographis paniculata; clinical trial; healthy volunteers; herbal tablets; safety