None listed
Conditions
Interventions
Intervention1: Sharvari bar: Sharvari bar used for a period of
4 weeks starting on day 2 after delivery (first post-partum day).
Control Intervention1: Control group placebo: Control group placebo (b
Sponsors
D Y Patil University School of Medicine
Eligibility
Inclusion criteria
Inclusion criteria: 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 4. Immediately post-partum, or within 3 days of delivery 5. Women able to understand the study requirements and can fill the study log diary, and follow other procedures required by the study protocol 6. Women who sign the informed written consen
Exclusion criteria
Exclusion criteria: 1. Post-partum women with contraindication to breastfeeding such as HIV, on chemotherapeutic drugs, on radioactive substances, baby with galactosemia, postpartum women with unstable conditions (i.e., postpartum haemorrhage, sepsis) 2. Women with known allergy to Shatavari or Oats, or asparagus 3. Women whose baby require phototherapy 4. Women with insufficient glandular tissue or breast surgery 5. Women with a history of infertility 6. Women with hypothyroidism 7. Women with twins or higher order births 8. Women with diabetes mellitus (type-1 or type-2) 9. Any known clinically significant endocrine, metabolic, hepatic, renal, cardiovascular, gastrointestinal, respiratory, haematological or neurological illnesses 10. Presence of any current psychiatric disorders in women 11. Any other investigational drug was used within three months prior the entry in this study.Research Proposal Sharvari for breast milk production ALS/Sharvari-PP/01-2021; Version 1.0, dt. 02/05/2021 Page 8 12. Those who cannot be relied upon to comply with the test procedures or are unwilling to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total volume (ml) of breast milk produced on the day 3 after birth (48 hours post-partum) during 15 minutes of pumping both breasts manually 2 hours after breastfeeding. Timepoint: Day 3 (48 hrs post-partum) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to noticeable breast fullness after delivery in hrs. Timepoint: Day 7-8 (post-partum day 5-7);2. Need for formula feeding. Timepoint: Day 7-8 (post -partum day 5-7);3. Total volume (ml) of breast milk produced on the day 7 after birth.Timepoint: Day 7-8 (post -partum day 5-7);4. Subjective satisfaction of mother regarding the well-being and happiness of babies on a 5-point Likert scale (very satisfied, satisfied, neutral, unsatisfied, very unsatisfied).Timepoint: Day 7-8 (post-partum day 5-7);5. The subjective satisfaction of mothers regarding the state of lactation on a 5-point Likert scale (very satisfied, satisfied, neutral, unsatisfied, very unsatisfied). Timepoint: Day 7-8 (post-partum day 5-7);6. Subjective satisfaction of Investigator regarding the well-being of mother on a 5-point Likert scale (very satisfied, satisfied, neutral, unsatisfied, very unsatisfied). Timepoint: Day 7-8 (post-partum day 5-7);7. Subjective satisfaction of Investigator regarding the well-being of baby on a 5-point Likert scale (very satisfied, satisfied, neutral, unsatisfied, very unsatisfied).Timepoint: Day 7-8(post-partum day 5-7) | — |
Countries
India
Contacts
Public ContactDr Meena Satia
D Y Patil Medical college
Outcome results
None listed