Zulkarnain Zuraida, Fitriani Ulfa, Ardiyanto Danang, Wijayanti Enggar, Triyono Agus, Novianto Fajar
Center for Research and Development of Medicinal Plants and Traditional Medicine, National Institute of Health Research and Development (NIHRD), Indonesian Ministry of Health Tawangmangu, Central Java, Indonesia.
J Complement Integr Med. 2024 Apr 23;21(4):532-539. doi: 10.1515/jcim-2020-0246. eCollection 2024 Dec 1.
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 of intervention 28 days. 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 14 days.
印度尼西亚有几种草药在经验上被用作催乳剂。然而，关于这些草药，尤其是复方草药的疗效和安全性的临床证据有限。本研究的目的是评估由卡图叶、托邦贡叶和番木瓜叶组成的复方草药催乳剂（PHG）与含有单一植物提取物卡图叶的商业催乳剂胶囊（CGC）相比的疗效和安全性。
本研究是一项开放标签随机对照试验，有120名受试者，随机分为两组，即PHG组和CGC组。本研究于2018年7月至11月在草药研究机构（草药研究之家/RRJ）药用植物园以及中爪哇省和日惹特区的30个分点进行。干预持续时间为28天。在基线、第14天和第28天测量母乳量、婴儿体重、催乳素水平等疗效参数以及谷丙转氨酶（ALT）、谷草转氨酶（AST）、尿素、肌酐等安全性参数。每周也记录副作用症状。
两组在第14天和第28天母乳量和婴儿体重均增加。然而，两组的催乳素水平均下降。两组在基线时疗效参数无显著差异。在三次测量中，ALT、AST、尿素和肌酐的平均水平均在正常范围内。约3 - 5%的母亲出现较高的ALT、AST以及恶心症状，但耐受性良好。在婴儿中未发现副作用。
PHG和CGC作为催乳剂具有同等的疗效和安全性。最佳使用时间为14天。
