Safety and impact evaluations of consuming beverage products containing ginger extract on breast milk quantity and quality and related mechanism in postpartum mothers.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

TCTR

Registry ID

TCTR20240930001

Enrollment

Registered

2024-09-30

Start date

2025-04-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum mothers after delivery on day 1-3, aged more than 18 years with normal health by Vital sign, Electrocardiogram, and Blood hematology &amp

Interventions

The group consume beverage products derived fruits and vetgetables without ginger extract 1 serving/day for 7 days.,The group consume beverage products derived fruits and vetgetables containing ginger

Placebo Comparator Other,Active Comparator Dietary Supplement,Active Comparator Dietary Supplement

Placebo,Beverage containing ginger extract 250 mg/serving/day ,Beverage containing ginger extract 500 mg/serving/day

Eligibility

Sex/Gender

Female

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. Postpartum mothers with normal Labor, after delivery on day 1-3, aged more than 18 years with normal health. 2. Mothers who give birth to healthy babies. 3. Mothers who want to breastfeed. 4. Can communicate, read and write in Thai language.

Exclusion criteria

Exclusion criteria: 1. Mastitis, breast abscess. 2. Consuming supplements that stimulate milk production. 3. Using domperidone, metoclopramide, antidepressive drugs. 4. Consuming or using caffeine and/or alcohol. 5. Having a serious illness and being unable to breastfeed for the first 6 hours after birth. 6. Having an infected perineal wound. 7. Have a history of ginger allergy. 8. A baby who needs to be separated from the mother after birth, such as infant asthma or suspected infant infection. 9. Currently participating in other programs.

Design outcomes

Primary

Measure	Time frame
Expressed breast milk (EBM) volume Baseline, day3, day5, day7 Using a breast pump 10-15 min/day	—

Secondary

Measure	Time frame
Demorgraphic data Baseline, day3, day5, day7 Vital sign, Electrocardiogram, Body Mass Index (BMI),Pain level Baseline, day3, day5, day7 Pain visual analogue scale, self evaluation,Safety parameters Screening, day7 Hematology, Blood biochemical markers, Blood electrolytes by Hospital Laboratory,Serum prolactin level Baseline, day3 ELISA kit, HHPHP laboratory,Serum antioxidative stress markers Baseline, day7 Level of MDA, CAT, SOD, GPx, HHPHP laboratory,Inflammatory markers; Level of IL-6, and IL-10 Baseline, day7 ELISA kits, HHPHP laboratory,Breast milk epidermal growth factor (EGF), IGF-1 transforming growth factor-beta (TGF-beta) Baseline, day7 ELISA kits, HHPHP laboratory	—

Measure

Time frame

Demorgraphic data Baseline, day3, day5, day7 Vital sign, Electrocardiogram, Body Mass Index (BMI),Pain level Baseline, day3, day5, day7 Pain visual analogue scale, self evaluation,Safety parameters Screening, day7 Hematology, Blood biochemical markers, Blood electrolytes by Hospital Laboratory,Serum prolactin level Baseline, day3 ELISA kit, HHPHP laboratory,Serum antioxidative stress markers Baseline, day7 Level of MDA, CAT, SOD, GPx, HHPHP laboratory,Inflammatory markers; Level of IL-6, and IL-10 Baseline, day7 ELISA kits, HHPHP laboratory,Breast milk epidermal growth factor (EGF), IGF-1 transforming growth factor-beta (TGF-beta) Baseline, day7 ELISA kits, HHPHP laboratory

—

Countries

Thailand

Contacts

Public ContactSophida Phuthong

Faculty of Medicine, Khon Kaen University

sophiph@kku.ac.th66973919163

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026