Galactagogue activity of poly-herbal decoction from Indonesia: a randomized open label controlled trial.

Abstract

Indonesia have several herbs empirically used as galactagogue. However there are limited clinical evidence regarding the efficacy and safety of this herbs especially poly-herb. The aim of this study was to assess the efficacy and safety of polyherbal galactagogue (PHG) consist of katuk leaves, torbangun leaves and papaya leaves compared to commercial galactagogue capsules (CGC) that contain a single plant extract, katuk leaves. This study was an open label randomized controlled trial with 120 subjects that randomly assigned into two groups, PHG and CGC. This study was conducted at the herbal medicine research house (Rumah Riset Jamu/RRJ) Hortus Medicus and 30 subsites in Central Java and Jogjakarta provinces from July to November 2018. Duration ofintervention 28days. Parameter of efficacy breast milk volume, baby weight, prolactin level and parameter of safety ALT, AST, Urea, Creatinin were performed at baseline, day 14 and 28. The symptom of side effects also recorded every week. Breast milk volume and infant's weight increased at day-14 and 28 in both groups. However, prolactin level in both groups decreased. There were no significant differences of efficacy parameters at baseline in both groups. At three times measurement of ALT, AST, Urea and Ceratinin average levels were within the normal range. About 3-5% mothers experience higher ALT, AST and nausea that can tolerated well. No side effect was found in infants. PHG and CGC have the equal efficacy and safety as a galactagogue. The optimal used is for 14days.