Universitas Indonesia Conferences, Asian Federation for Pharmaceutical Sciences (AFPS) 2019

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The efficacy and safety of Ethyl Acetate Fraction Tablet of Andrographis paniculata (AS201-01) in Malarial Uncomplicated Patient
Aty Widyawaruyanti, Michel A Siwabessy, Michel A Siwabessy, Michel A Siwabessy, Endang Widiastuti, Endang Widiastuti, Endang Widiastuti, Lidya Tumewu, Lidya Tumewu, Lidya Tumewu, Hilkatul Ilmi, Hilkatul Ilmi, Hilkatul Ilmi, Maria Nindatu, Maria Nindatu, Maria Nindatu, Lilis Dachliyati, Lilis Dachliyati, Lilis Dachliyati, Muhammad Faisal Budiman, Muhammad Faisal Budiman, Muhammad Faisal Budiman, Achmad Fuad Hafid, Achmad Fuad Hafid, Achmad Fuad Hafid, Indah Setyawati Tantular

Last modified: 2019-07-13

Abstract


Background: Malaria is a disease that is still a world health threat. Drug development for antimalarials is still urgent because of the emergence of malaria resistance. Andrographis paniculata was known as potential antimalarial. Ethyl acetate fraction of Andrographis paniculata was formulated as a tablet dosage form, namely AS201-01. In preclinical trials, AS201-01 known to have potent bioactivity as an antimalarial and no unwanted side effects in vivo. The result of clinical trial in healthy volunteers also showed that AS201-01 tablet that have given twice a day for four days is safe. Objective: The aim of this study is to evaluate the efficacy and safety of AS201-01 tablet in malarial uncomplicated patient . Materials and Methods: This research was conducted in Piru, west of Seram, Maluku, Indonesia. Malaria patient consisting of male and non-pregnant female aged 18–50 years were screened and randomised. One hundred subject were divided into two groups and each group were given 4 tablets, twice daily for 4 days. The subject recived AS201-01 and Dihidroartemisinin Piperaquine (DHP) tablets. Evaluted to efficacy of AS201-01 tablet was carried out by examination of blood smear from fingertips on days 0, 1, 2, 3, 4, 7, 14, 21 and 28. Parameters of biochemistry and hematology profiles also were investigated to evaluated the safety of AS201-01 tablet. Results: The result of evaluated antimalarial showed that 66% subjects and 62% subjects had negative parasitemia on day 4 after AS201-01 treatment and DHP, respectively. Statistical analysis results showed that there was no significant difference in parasitemia percentage between subjects treated with AS201-01 and DHP. This shows that the AS201-01 tablet has the same potential as DHP in cleaning malaria parasites. All biochemistry profiles were in the normal range pre and post treatments with AS201-01 and no unwanted side effects were observed during therapy. Statistical analysis results showed that there was no significant difference (P>0.05) on liver function and renal function among subject given AS201-01 tablets compared with the DHP tablet. Conclusion: The AS201-01 tablet that have been given twice a day for four days is effective as an antimalarial and safe. In the future, this tablet could be a potential candidate as an alternative medicine for malarial treatment.