Abstract
Objectives
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.
Methods
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.
Results
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.
Conclusions
PHG and CGC have the equal efficacy and safety as a galactagogue. The optimal used is for 14 days.
Funding source: Indonesia Ministry of Health
Award Identifier / Grant number: HK.02.03/2/3136/2018
Acknowledgment
The authors would like to thanks to Dina Rismawati, MD Pediatrician and DR. Vitri Widyaningsih, MD, PhD for the excellent consultation during the preparation of protocol and intervention.
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Research ethics: This study was approved by ethical board of NIHRD, MoH of Indonesia with the number LB. 02.01/2/KE.248/2018.
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Informed consent: Informed consent was obtained from all individuals included in this study, or their legal guardians or wards.
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Author contributions: The authors have accepted responsibility for the entire content of this manuscript and approved its submission.
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Competing interests: The authors state no conflict of interest.
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Research funding: This study was funded by National Institute of Health Research and Development, Indonesian Ministry of Health.
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Data availability: The raw data can be obtained on request from the corresponding author.
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Supplementary Material
This article contains supplementary material (https://doi.org/10.1515/jcim-2020-0246).
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