A Randomized, Double-blind, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of HGLG-032406 as a Galactagogue Supplement in Post-partum Lactating Women.
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Efficacy;
研究概览
简要总结
Title: A Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of HGLG-032406 as a Galactagogue Supplement in Post-partum Lactating Women.
Objective: To evaluate the efficacy and safety of HGLG-032406 as a galactagogue supplement in post-partum lactating women.
Study Design: Randomized, Double-Blind, Placebo-Controlled Clinical Study
Study Population: Post-partum women aged 20-45 who meet specific inclusion criteria, including healthy women with or without lactation insufficiency, willing to exclusively breastfeed their infants.
Intervention: HGLG-032406 (galactagogue supplement) or similar-looking placebo (nutritional supplement without lactogenic effect) administered for 12 weeks.
Endpoints:
-
Change in volume (ml) of breast milk produced after breast fullness, measurement by breast pump(Manual/Automatic).
-
Mean change in serum prolactin levels in post-partum women.
-
Improvement in perceived insufficient milk questionnaire scoring.
-
Mean change in infant weight after delivery.
-
General Physical Examinations
-
Incidence of adverse events.
-
Organoleptic product feedback
Study Visits: There will be 3 study visits for each subject:
- Visit 1 - Screening/Enrolment/Baseline Visit
- Visit 2 - At the end of 4th week (Day 28 ± 4 days)
- Visit 3 - At the end of 12th week (Day 84 ± 4 days)/End of Study (EOS). Dosage: 2 scoopfuls (10gms) twice daily with one glass of milk.
This study aims to assess the safety and efficacy of HGLG-032406 as a galactagogue supplement in post-partum lactating women, with a target sample size of 120 evaluable subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Healthy women between 20 to 45 years with or without lactation insufficiency.
- •Women who are in between 3-15 days of postpartum.
- •Women with uncomplicated full-term delivery (only vaginal or LSCS).
- •Women who are willing to exclusively breastfeed their infants.
- •Women with body mass index (BMI) 18.5-29.9 kg/m
- •6.Women having a healthy infant with a birth weight ranging from 2.5 kg to 4.5 kg and an Apgar score of 7 or higher.
- •In specific instances, at the discretion of the investigator, healthy infants born pre-term or early term with a birth weight below 2.5 kg may also be included in the study.
- •7.Women who have not participated in any clinical study in the past 1 year.
- •Women willing to sign informed consent and follow the study procedure.
排除标准
- •1.Post-partum women with contraindications to breastfeeding, such as HIV, chemotherapeutic drugs, radioactive substances, and others as determined by the investigator.
- •2.Post-partum women with clinically significant health conditions (i.e., post-partum hemorrhage, sepsis).
- •3.Women with known allergies to any of the ingredients of investigational product.
- •4.Women already using proprietary drugs / supplements that have galactagogue properties.
- •5.Women with insufficient glandular tissue or breast surgery and any structural abnormality of the breast.
- •6.Women with triplets or more.
- •7.Women with genetic or hormonal disorders causing prolactin deficiency.
- •8.Women with hyperlactation symptoms like frequent blocked ducts or mastitis, leaking a lot of milk between feedings, full or uncomfortable breast even after feeding.
- •Mothers and/ or infants with galactosemia.
- •10.Infants with sucking problems or congenital anomalies (cleft lip, cleft palate), birth trauma, premature birth.
- •Women having history of alcoholism, smoking or other substance use according to DSM-V criteria.
- •Women with known clinically significant endocrine, metabolic, hepatic, renal, cardiovascular, gastrointestinal, respiratory, hematological, or neurological illnesses.
- •Mother and/or infants with major illness that requires intensive care admission/any pregnancy or parturition related clinically significant conditions.
- •Women with any other reason (physical, psychological, or social) that can interfere with the compliance to the study in the opinion of the Investigator.
结局指标
主要结局
Efficacy;
时间窗: Day1, Day 28 and Day 84
1.Change in volume (ml) of breast milk produced after breast fullness, measurement by breast pump(Manual/Automatic).
时间窗: Day1, Day 28 and Day 84
2.Mean change in serum prolactin levels in post-partum women.
时间窗: Day1, Day 28 and Day 84
3.Improvement in perceived insufficient milk questionnaire scoring.
时间窗: Day1, Day 28 and Day 84
4.Mean change in infant weight after delivery.
时间窗: Day1, Day 28 and Day 84
次要结局
- 1. General Physical Examinations(2. Laboratory Examinations)
研究者
Dr Veena BT
Sidvin Hospital Pvt.Ltd