None listed
Conditions
Interventions
None listed
Sponsors
Dr Ashvini Deshmukh
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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. 5.Women whose babies require phototherapy, women with insufficient glandular tissue or breast surgery and any structural abnormality of the breast. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Total volume (ml) of breast milk produced on the third post-partum day; Measurement by Breast pump (Manual/Automatic). 2.Mean time noticeable from birth to evident breast fullness after delivery.Timepoint: Day 3 (72 hours) | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in infant weight after delivery.Timepoint: Day 3 (72 hours), Week 4, Week 16;Mean change in protein content (albumin and globulin) and specific gravity in breast milk during post-partum women after delivery.Timepoint: Baseline, Week 4, Week 16;Mean change in serum prolactin levels in post-partum women after delivery.Timepoint: Baseline, Week 4, Week 16;Mean time (hours) to evident noticeable breast fullness after last breast feeding (measured during daytime).Timepoint: Week 4, Week 16;Proportion of infants developing infections.Timepoint: Week 4, Week 16;Proportion of women experiencing Treatment-Emergent Adverse Events (TEAEs).Timepoint: Baseline, Week 4, Week 16;Proportion of women experiencing Treatment-Emergent Serious Adverse Events (TESAEs).Timepoint: Baseline, Week 4, Week 16;Self ?reported insufficient milk (SRIM) assessment by mother for their decision to wean their infant.Timepoint: Week 4, Week 16;Total volume (ml) of breast milk produced after breast fullness; measurement by breast pump (Manual/Automatic)Timepoint: Week 4, Week 16;Use of infant formula feed.Timepoint: Week 4, Week 16 | — |
Countries
India
Contacts
Public ContactDr Ashvini Deshmukh
D. Y. Patil Deemed to be University, School of Medicine, Navi Mumbai
Outcome results
None listed