None listed
Conditions
Interventions
None listed
Sponsors
Himalaya Wellness Company
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy women between 20 to 45 years with or without lactation insufficiency. 2. Women who are in between 3-15 days of postpartum. 3. Women with uncomplicated full-term delivery (only vaginal or LSCS). 4. Women who are willing to exclusively breastfeed their infants. 5. Women with body mass index (BMI) 18.5-29.9 kg/m2. 6.Women having a healthy infant with a birth weight ranging from 2.5 kg to 4.5 kg and an Apgar score of 7 or higher. In specific instances, at the discretion of the investigator, healthy infants born pre-term or early term with a birth weight below 2.5 kg may also be included in the study. 7.Women who have not participated in any clinical study in the past 1 year. 8. Women willing to sign informed consent and follow the study procedure.
Exclusion criteria
Exclusion criteria: 1.Post-partum women with contraindications to breastfeeding, such as HIV, chemotherapeutic drugs, radioactive substances, and others as determined by the investigator. 2.Post-partum women with clinically significant health conditions (i.e., post-partum hemorrhage, sepsis). 3.Women with known allergies to any of the ingredients of investigational product. 4.Women already using proprietary drugs / supplements that have galactagogue properties. 5.Women with insufficient glandular tissue or breast surgery and any structural abnormality of the breast. 6.Women with triplets or more. 7.Women with genetic or hormonal disorders causing prolactin deficiency. 8.Women with hyperlactation symptoms like frequent blocked ducts or mastitis, leaking a lot of milk between feedings, full or uncomfortable breast even after feeding. 9. Mothers and/ or infants with galactosemia. 10.Infants with sucking problems or congenital anomalies (cleft lip, cleft palate), birth trauma, premature birth. 11. Women having history of alcoholism, smoking or other substance use according to DSM-V criteria. 12. Women with known clinically significant endocrine, metabolic, hepatic, renal, cardiovascular, gastrointestinal, respiratory, hematological, or neurological illnesses. 13. Mother and/or infants with major illness that requires intensive care admission/any pregnancy or parturition related clinically significant conditions. 14. Women with any other reason (physical, psychological, or social) that can interfere with the compliance to the study in the opinion of the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy; 1.Change in volume (ml) of breast milk produced after breast fullness, measurement by breast pump(Manual/Automatic). 2.Mean change in serum prolactin levels in post-partum women. 3.Improvement in perceived insufficient milk questionnaire scoring. 4.Mean change in infant weight after delivery.Timepoint: Day1, Day 28 and Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. General Physical Examinations 2. Laboratory Examinations 3. Incidence of adverse event reporting. 4. Organoleptic product feedback.Timepoint: Day1, Day 28 and Day 84 | — |
Countries
India
Contacts
Public ContactDr Soorya Narayan H
Himalaya Wellness Company
Outcome results
None listed