Evidence map›Paper›PMID 40188102›Full record

Trial reportInternational breastfeeding journal2025

Clinical evaluation of Ayush-SS granules in exclusively breastfeeding mothers with insufficient lactation: A randomized, double-blind, placebo-controlled trial.

Upma Saxena, Sarada Ota, Shivshankar Rajput, Bhavna Anand, Arunabh Tripathi, Richa Singhal, Adarsh Kumar, Abhishek Lachyan

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in International breastfeeding journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Upma SaxenaDepartment of Obstetrics & Gynecology, VMMC and Safdarjung Hospital, New Delhi, India. drupmasaxena@gmail.com.
Sarada OtaCentral Ayurveda Research Institute, Bhubaneswar, India.
Shivshankar RajputCentral Ayurveda Research Institute, Punjabi Bag, New Delhi, India.
Bhavna AnandDepartment of Pediatrics, VMMC and Safdarjung Hospital, New Delhi, India.
Arunabh TripathiCentral Council for Research in Ayurvedic Sciences, New Delhi, India.
Richa SinghalCentral Council for Research in Ayurvedic Sciences, New Delhi, India.
Adarsh KumarCentral Council for Research in Ayurvedic Sciences, New Delhi, India.
Abhishek LachyanDepartment of Obstetrics & Gynecology, VMMC and Safdarjung Hospital, New Delhi, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBreast milk is essential for infant growth and development, with exclusive breastfeeding (EBF) recommended for the first six months. Many mothers experience insufficient milk production, leading to early supplementation or cessation of breastfeeding. Ayurvedic formulations, such as Ayush-SS granules, have been proposed to enhance lactation. This study evaluated Ayush-SS granules as a galactagogue, with EBF at six months as the primary outcome. Secondary outcomes included infant weight gain over 90 days and maternal perceptions of lactation sufficiency.

methodsA double-blind, randomized, placebo-controlled trial was conducted between 1 February 2021 and 31 January 2023 at Vardhman Mahavir Medical College and Safdarjung Hospital, Delhi, India. A total of 210 lactating mothers (aged 20-40 years) with full-term singleton infants (≥ 37 weeks, ≥ 2.5 kg) experiencing insufficient lactation were enrolled. Infants who had not regained birth weight by day 14 or gained < 20 g/day after day 15 were included. Participants were randomized (1:1) to receive 6 g of Ayush-SS granules or placebo twice daily for 12 weeks. All participants received standardized breastfeeding counseling. Safety monitoring was conducted, and an intention-to-treat analysis was performed.

resultsAt six months, 74 of 106 (69.8%) infants in the Ayush-SS group were exclusively breastfed, compared to 47 of 105 (44.8%) in the placebo group (p < 0.001). After 90 days, 81 of 106 infants (76.5%) in the Ayush-SS group gained ≥ 20 g/day compared to 44 of 105 (41.8%) in the placebo group (p < 0.001). Maternal perceptions of insufficient lactation were significantly lower in the Ayush-SS group (15.3% vs. 58.2%). No severe adverse events related to the intervention were observed.

conclusionAyush-SS granules significantly improved EBF rates at six months, maternal perceptions of lactation sufficiency, and infant weight gain. These findings suggest their potential as a galactagogue for mothers with insufficient milk production. Further research is needed to explore long-term effects and maternal dietary influences. CLINICAL

trial registrationCTRI/2019/08/020579 [Registered on: 06/08/2019].

Indexed as

Breast FeedingLactationMedicine, AyurvedicAdultDouble-Blind MethodFemaleHumansIndiaInfantInfant, NewbornMaleMilk, HumanMothersYoung AdultAyush-SS granulesBreastfeedingComplementary medicineNeonatal nursing

Identifiers

PMID40188102
PMCPMC11972481

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.