CTRI/2026/02/104903尚未招募不适用
A Randomized, Multi-Centered, Two-Arm, Double-Blind, Placebo-Controlled Clinical Trial for Generating Evidence on The Efficacy of the Herbal Galactagogue Lactare Plus for Augmentation of Lactation Among Postpartum Mothers
Mankind Pharma Ltd3 个研究点 分布在 1 个国家目标入组 228 人开始时间: 2026年3月9日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 228
- 试验地点
- 3
研究概览
简要总结
This randomized, multi-centered, two-arm, double-blind, placebo-controlled clinical study will enroll postpartum mothers experiencing delayed onset of lactation. Participants will be randomized in a 1:1 ratio using block randomization to receive either Lactare Plus® capsules combined with standardized non-pharmacological breastfeeding support or matching placebo capsules combined with standardized non-pharmacological breastfeeding support. This design will allow evaluation of the efficacy and safety of Lactare Plus® in augmenting lactation compared to placebo when both groups receive identical structured non-pharmacological breastfeeding support.
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
- 19.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •Healthy female trial participants aged more than or equal to 19 years undergone an uncomplicated delivery
- •Trial participants willing to provide written informed consent and comply with the study visit schedule and procedures.
- •Singleton/twin live birth, gestational age more than or equal 37 weeks.
- •Absence of lactation within 72 hours post-delivery, or as determined by the Principal Investigator.
- •Intends to continue breastfeeding for at least 5 weeks.
排除标准
- •Infants with malformations that could affect feeding or growth.
- •Infants with illness or mothers with severe illness or severe malnutrition.
- •Lactating women who have a diagnosis of mastitis.
- •Lactating women with debilitating chronic illness.
- •Any other medical conditions or medications, according to the investigator, would interfere directly with the results of the study or jeopardize the health of the participant.
研究者
Dr Hanee Hemantkumar Patel
Harmony Hospital
研究点 (3)
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