CTRI/2024/03/063574进行中（未招募）4 期
Evaluation of Efficacy and Safety of Galact Granules (Shatavari Formulation) as a Galactagogue in Post-partum Women: A Prospective, Randomized, Double-blind, Placebo-Controlled Study
Dr Ashvini Deshmukh1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2024年3月11日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- 1.Total volume (ml) of breast milk produced on the third post-partum day; Measurement by Breast pump (Manual/Automatic).
研究概览
简要总结
- All eligible women who meet the inclusion and exclusion criteria will be part of the study.
Participants will be informed about the purpose of the study and signed informed consent will be taken.
All participants will be followed-up during the study period (visit 1 (screening visit/ enrolment visit/ baseline visit- day 1), visit 2 (Day 3- 72 hours after delivery), visit 3 (week 4) ± 4 days, visit 4 (week 16) ± 4 days.
The adverse events, either spontaneously reported by the participant, or noticed by the clinician will be recorded during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor 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
- •1.Healthy women between 20-45 years of age 2.Women with uncomplicated full-term delivery (vaginal or LSCS).
- •3.Women who have accomplished antenatal breastfeeding promotion protocol immediately post-partum or within three days of delivery.
- •4.Women able to understand the study requirements and follow other procedures required by the study protocol.
- •5.Must have the ability and willingness to sign an informed consent and to comply with all study procedures.
排除标准
- •1.Post-partum women with contraindications to breastfeeding, such as HIV, chemotherapeutic drugs, radioactive substances, and babies with galactosemia.
- •2.Post-partum women with unstable conditions (i.e., post-partum hemorrhage, sepsis).
- •3.Women with known allergies to Shatavari or other ingredients of Galat granules.
- •4.Women already using products that have galactagogue properties.
- •6.Women with a history of infertility, hypothyroidism, women with twins, or higher-order births.
- •7.Any known clinically significant endocrine, metabolic, hepatic, renal, cardiovascular, gastrointestinal, respiratory, hematological, or neurological illnesses or the presence of any current psychiatric disorders in women will be considered as exclusion criteria.
- •8.If any other investigational drug was used within three months before the entry in this study or those who cannot be relied upon to comply with the test procedures or are unwilling to give informed consent will be excluded.
结局指标
主要结局
1.Total volume (ml) of breast milk produced on the third post-partum day; Measurement by Breast pump (Manual/Automatic).
时间窗: Day 3 (72 hours)
2.Mean time noticeable from birth to evident breast fullness after delivery.
时间窗: Day 3 (72 hours)
次要结局
- Total volume (ml) of breast milk produced after breast fullness; measurement by breast pump (Manual/Automatic)(Week 4, Week 16)
- Mean change in protein content (albumin and globulin) and specific gravity in breast milk during post-partum women after delivery.(Baseline, Week 4, Week 16)
- Mean change in serum prolactin levels in post-partum women after delivery.(Baseline, Week 4, Week 16)
- Mean time (hours) to evident noticeable breast fullness after last breast feeding (measured during daytime).(Week 4, Week 16)
- Use of infant formula feed.(Week 4, Week 16)
- Selfâ€reported insufficient milk (SRIM) assessment by mother for their decision to wean their infant.(Week 4, Week 16)
- Proportion of infants developing infections.(Week 4, Week 16)
- Mean change in infant weight after delivery.(Day 3 (72 hours), Week 4, Week 16)
- Proportion of women experiencing Treatment-Emergent Adverse Events (TEAEs).(Baseline, Week 4, Week 16)
- Proportion of women experiencing Treatment-Emergent Serious Adverse Events (TESAEs).(Baseline, Week 4, Week 16)
研究者
Dr Ashvini Deshmukh
D. Y. Patil Deemed to be University, School of Medicine, Navi Mumbai
研究点 (1)
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