CTRI/2024/10/074731尚未招募不适用
A Prospective, Randomized, Double-Blind, Placebo-Controlled Study on the Effect of Shatavari on Post-Partum Lactation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Mean time noticeable from birth to evident breast fullness after delivery
研究概览
简要总结
· All eligible subjects who meet the Inclusion and Exclusion criteria will be part of the study.
· Subjects will be informed about the purpose of the study and signed informed consent will be taken.
· All subjects will be followed-up during the study period (first 72 hours after delivery).
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 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Healthy women between 20-40 years of age 2.Women with uncomplicated full-term delivery (vaginal or LSCS).
- •3.Women who have accomplished antenatal breastfeeding promotion protocol immediately postpartum or within three days of delivery.
- •4.Women able to understand the study requirements and can fill the study log diary, 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.Postpartum women with contraindications to breastfeeding, such as HIV, chemotherapeutic drugs, radioactive substances, and babies with galactosemia.
- •2.Postpartum women with unstable conditions (i.e., postpartum hemorrhage, sepsis).
- •3.Women with known allergies to Shatavari or oats, raisins, almonds, cocoa, and honey.
- •5.Women with a history of infertility, hypothyroidism, women with twins, or higher-order births.
- •6.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.
- •7.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
Mean time noticeable from birth to evident breast fullness after delivery
时间窗: Day 3- 72 hours after delivery
Total volume (ml) of breast milk produced on the third postpartum day; Measurement by Breast pump (Manual/Automatic).
时间窗: Day 3- 72 hours after delivery
次要结局
- Subjective assessments on time to noticeable breast fullness after delivery using five-point Likert scale.(Day 3- 72 hours after delivery)
- Subjective assessments of mother regarding the well-being and happiness of newborn, regarding the state of lactation using five-point Likert scale(Day 3- 72 hours after delivery)
- Subjective assessments of investigator regarding the well-being of the mother, and regarding the well-being of the newborn using five-point Likert scale.(Day 3- 72 hours after delivery)
- Proportion of patients experiencing Treatment-Emergent Adverse Events (TEAEs).(Day 3- 72 hours after delivery)
- A proportion of patients experiencing Treatment-Emergent Serious Adverse Events (TESAEs).(Day 3- 72 hours after delivery)
研究者
Dr Ashutosh Ajgaonkar
Trupti Hospital
研究点 (1)
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