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A Doubled-Blind, Crossover-RCT in T2DM for Evaluating Hypoglycemic Effect of P. indicus, M. charantia, P. vulgaris and A. paniculata in Central Java


Affiliations
1 Center for Health and Biomedical Study, Research Institute of UNNES, Department of Public Health, Universitas Negeri Semarang, Indonesia
2 Njonja Meneer Research and Development Laboratory, Semarang, Indonesia
3 Sultan Agung Islamic Hospital, Semarang, Indonesia
4 Department of Internal Medicine, Universitas Islam Sultan Agung, Semarang, Indonesia
5 Division of Physiology, Department of Anatomy, Physiology and Cell Biology, Universitas Padjadjaran, Bandung, Indonesia
 

This study investigated whether mixture extract of Pterocarpus indicus, Momordica charantia, Phaseolus vulgaris and Andrographis paniculata could lower plasma glucose in Type 2 Diabetes Mellitus (T2DM) patients. 43 T2DM patients, consist of 10 male and 33 female patients participated in this possitive-controlled, double-blind, and crossover clinical study with administration of either mixture extract (22 mg/kg BW) or glibenclamide 5 mg daily in breakfast time. Treatment of extract or glibenclamide was administered for a month, then medication was changed after a week of washout period and finally combination therapy was administered after wash out period as well. The efficacy of mixture extracts was measured by using Fasting Plasma Glucose (FPG) and two-hour Postprandial Plasma Glucose (PPG). Forty-one subjects completed the study. Data was analyzed using SPSS 19 with Student's t test, and p<0.05 was considered significant. FPG level significantly decreased 16.07 mg/dl after extract, 43.34 mg/dl after glibenclamide and 50.16 mg/dl after combination treatment. Two-hour PPG level decreased 25.88 mg/dl after extract, 66.61 after glibenclamide and 58.93 after combination treatment. We concluded that extract administration could lower FPG and PPG although not as good as glibenclamide treatment did and combination treatment was the best to lower FPG.

Keywords

Anti-Diabetic, Clinical-Trial, Extract, Herbal-Medicine.
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  • A Doubled-Blind, Crossover-RCT in T2DM for Evaluating Hypoglycemic Effect of P. indicus, M. charantia, P. vulgaris and A. paniculata in Central Java

Abstract Views: 470  |  PDF Views: 160

Authors

Mahalul Azam
Center for Health and Biomedical Study, Research Institute of UNNES, Department of Public Health, Universitas Negeri Semarang, Indonesia
Charles Ong Saerang
Njonja Meneer Research and Development Laboratory, Semarang, Indonesia
Sri Ratna Rahayu
Center for Health and Biomedical Study, Research Institute of UNNES, Department of Public Health, Universitas Negeri Semarang, Indonesia
Fitri Indrawati
Center for Health and Biomedical Study, Research Institute of UNNES, Department of Public Health, Universitas Negeri Semarang, Indonesia
Irwan Budiono
Center for Health and Biomedical Study, Research Institute of UNNES, Department of Public Health, Universitas Negeri Semarang, Indonesia
Arulita Ika Fibriana
Center for Health and Biomedical Study, Research Institute of UNNES, Department of Public Health, Universitas Negeri Semarang, Indonesia
Muhammad Azinar
Center for Health and Biomedical Study, Research Institute of UNNES, Department of Public Health, Universitas Negeri Semarang, Indonesia
Nur Anna C. Sa'dyah
Sultan Agung Islamic Hospital, Semarang, Indonesia
Erwin Budi Cahyono
Department of Internal Medicine, Universitas Islam Sultan Agung, Semarang, Indonesia
Ronny Lesmana
Division of Physiology, Department of Anatomy, Physiology and Cell Biology, Universitas Padjadjaran, Bandung, Indonesia

Abstract


This study investigated whether mixture extract of Pterocarpus indicus, Momordica charantia, Phaseolus vulgaris and Andrographis paniculata could lower plasma glucose in Type 2 Diabetes Mellitus (T2DM) patients. 43 T2DM patients, consist of 10 male and 33 female patients participated in this possitive-controlled, double-blind, and crossover clinical study with administration of either mixture extract (22 mg/kg BW) or glibenclamide 5 mg daily in breakfast time. Treatment of extract or glibenclamide was administered for a month, then medication was changed after a week of washout period and finally combination therapy was administered after wash out period as well. The efficacy of mixture extracts was measured by using Fasting Plasma Glucose (FPG) and two-hour Postprandial Plasma Glucose (PPG). Forty-one subjects completed the study. Data was analyzed using SPSS 19 with Student's t test, and p<0.05 was considered significant. FPG level significantly decreased 16.07 mg/dl after extract, 43.34 mg/dl after glibenclamide and 50.16 mg/dl after combination treatment. Two-hour PPG level decreased 25.88 mg/dl after extract, 66.61 after glibenclamide and 58.93 after combination treatment. We concluded that extract administration could lower FPG and PPG although not as good as glibenclamide treatment did and combination treatment was the best to lower FPG.

Keywords


Anti-Diabetic, Clinical-Trial, Extract, Herbal-Medicine.

References





DOI: https://doi.org/10.18311/jnr%2F2016%2F7539