Efficacy and Safety of Shatavari granules to increase milk in women after delivery.

Phase 4

• Registration Number: CTRI/2024/03/063574
• Lead Sponsor: Dr Ashvini Deshmukh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Total volume (ml) of breast milk produced on the third post-partum day; Measurement by Breast pump (Manual/Automatic). <br/ ><br>2.Mean time noticeable from birth to evident breast fullness after delivery.Timepoint: Day 3 (72 hours)