The clinical study of Lysiphyllum Strychifolium on breast milk productio

Phase 2

Completed

• Conditions: Breast milk is the best food for infants because it contains essential nutrients for growth and development. Currently, the World Health Organization (WHO) supports 6 months exclusive breastfeeding.; Lysiphyllum strychnifolium; Ya- Nang- Daeng; breast milk volume; prolactin level

• Registration Number: TCTR20190716001
• Lead Sponsor: Thammasat University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-16
• Study Completion: 2019-08-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 84

Inclusion Criteria

Nursing women;
- Age between 20-40 years
- Normal delivery
- Exclusively breastfeeding
- No postpartum haemorrhage (Hematocrit less than 10% of the original hematocrit before birth and blood loss less than 1,000 cc)
- No history of drug, food or herb allergy
- Consent to join the study and consent to get the serum prolactin levels check, and have normal diet intake
For infants;
- Full term
- Healthy neonates

Exclusion Criteria

Nursing women;
- Chronic illness such as diabetes, hypertension, bronchial asthma and any allergies
- Breast problems such as inverted nipples, mastitis, engorgement, cracks etc.
- History of smoking, alcohol, or any drug use for improving breast milk production
- Infant twins
- These women will receive blood test during pregnancy that had positive finding of this illness such as hepatitis B, AIDS, syphilis
For infants;
- Low birth weight (birth weight at least 2,500 g)
- Low APGAR scores and/or intrauterine growth retardation
- No congenital abnormalities

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Breast milk volume at 10 days after delivery electric breast pump,quality of breast milk at day 4 and 10 after delivery Chemical analysis

Secondary Outcome Measures

Name	Time	Method
plasma prolactin level at 10 days after delivery Chemiluminescence Immunoassay (CLIA),oxytocin level at 10 days after delivery Oxytocin ELISA kit,weight infants at 10 days after delivery sensitive digital scale,quality of breast milk at 10 days after delivery Chemical analysis