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Submitted: 17 August 2011 Modified: 17 August 2011
HERDIN Record #: PCHRD08171109081990

Comparative efficacy and safety study of Momordica charantia, L. (ampalaya) leaf tablet and glibenclamide among patients with non-insulin dependent diabetes mellitus (Phase 1 and early phase 11 clinical drug trial).

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A double-blind comparative study of the efficacy and safety of ampalaya leaf tablet and glibenclamide among NIDDM patients recruited in the outpatient department of PGH was conducted. A total of twenty-one patients who met the inclusion criteria was randomly assigned to either the ampalaya or glibenclamide group after a wash-out period of two weeks. Five subjects were treated with low dose (45 mg/kg/day), another eight subjects with high dose (60 mg/kg/day), and the third group of eight subjects were treated with glibenclamide at 2.5 or 5 mg/tablet depending on their previous dose. Results showed that glibenclamide and high dose ampalaya are not comparable at 1% level of significance. The same is true between the high dose and low dose ampalaya. However, the low dose group does not significantly differ from the glibenclamide group. These conflicting results can be due to the unequal number of subjects and the higher baseline FBS values of the high dose group than those of the low dose. However, due to the small number of subjects who completed the study and due to the low potency of the raw ampalaya used in the tablet formulation, the results are not conclusive. All the patients did not develop adverse reactions. (Author)

Publication Type
Research Project
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Objectives

General Objectives:1. To determine the dose of Momordica charantia, L. ("ampalaya") leaf preparation which will be effective in lowering the blood sugar level comparable to that of glibenclamide when administered to patients with noninsulin dependent diabetes mellitus.2. To determine and compare the safety and acceptability of Momordica charantia, L. ("ampalaya") leaf preparation with an oral hypoglycemic agent (glibenclamide) among patients with noninsulin dependent diabetes mellitus.Specific Objectives:1. To obtain socio-demographic profile of patients with NIDDM as to age, sex, weight, family history, duration of disease, presence of other diseases, diet and drug intake.2. To determine the efficacy of the low dose and high dose ampalaya leaf tablets as to its hypoglycemic effect.3. To compare the efficacy of the two doses (low dose and high dose) with an oral hypoglycemic agent (glibenclamide).3.1. To compare the efficacy of the low dose (45 mg/kg/day) ampalaya leaf tablet with glibenclamide.3.2. To compare the efficacy of the high dose (60 mg/kg/day) ampalaya leaf tablet with glibenclamide.4. To determine the safety and acceptability of the ampalaya leaf tablets.4.1. To determine the adverse events with the use of ampalaya leaf tablets.4.2. To determine if there is a dose-related adverse effects with the use of the ampalaya leaf tablets.5. To compare the safety and acceptability of the ampalaya leaf tablets with glibenclamide.5.1. To compare the adverse effects of the ampalaya leaf tablets with glibenclamide.5.2. To analyze for any statistically significant difference as to incidence, severity and type of reactions among patients treated with ampalaya tablets in comparison with those treated with glibenclamide.

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