Health Condition 1: O998- Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium
Conditions
Interventions
None listed
Sponsors
Ixoreal Biomed Private Limited
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 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
Exclusion criteria
Exclusion criteria: 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. 4.Women whose babies require phototherapy, women with insufficient glandular tissue or breast surgery and any structural abnormality of the breast. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean time noticeable from birth to evident breast fullness after delivery Total volume (ml) of breast milk produced on the third postpartum day; Measurement by Breast pump (Manual/Automatic). Timepoint: Day 3- 72 hours after delivery | — |
Secondary
| Measure | Time frame |
|---|---|
| A proportion of patients experiencing Treatment-Emergent Serious Adverse Events (TESAEs).Timepoint: Day 3- 72 hours after delivery;Proportion of patients experiencing Treatment-Emergent Adverse Events (TEAEs).Timepoint: 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.Timepoint: 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 scaleTimepoint: Day 3- 72 hours after delivery;Subjective assessments on time to noticeable breast fullness after delivery using five-point Likert scale.Timepoint: Day 3- 72 hours after delivery | — |
Countries
India
Contacts
Public ContactDr Ashutosh Ajgaonkar
Trupti Hospital
Outcome results
None listed