RESEARCH ARTICLE Clinical efficacy of Gossypium herbaceum L. seeds in perceived insufficient milk (PIM) supply: A randomized single-blind placebo-controlled study S. Manjula & Arshiya Sultana & Khaleequr Rahman Received: 3 April 2013 / Accepted: 20 May 2013 # Institute of Korean Medicine, Kyung Hee University 2013 Abstract To evaluate the efficacy of Gossypium herbaceum L. in perceived insufficient milk (PIM) supply. In this single-blind, placebo-controlled, randomized clinical trial, test group ( n =30), received kernel of Gossypium herbaceum, 10 g (powder filled in the capsules) orally in three divided doses for 1 month, whereas the placebo group (n =15), received wheat flour. The primary outcome mea- sures were reduction in volume of supplementary feeds, and weight gain of the baby. The secondary outcome measures were improvement in subjective satisfaction of the mothers regarding the well being and happiness of babies, feeling fullness in the breast, contra lateral ejection of the milk, and mother’ s observation in increase of breast milk. These pa- rameters were rated on a graded scale ranging from 1 to 5 (1 denoting unsatisfactory and 5 representing highly satisfactory). The data was analyzed by using Student’ s t test, Chi-square or Fisher exact test to find the significance (P <0.05) of the study parameters. In the test group, 21(70 %), 7(23.33 %) and 2(6.67 %) mothers had complete relactation, partial relactation and no response correspondingly, whereas in the control group 4(26.67 %) mothers had complete relactation, and 11(73.33 %) mothers had no response. The volume of supplementary feeds to the infant in the test group was significantly reduced to 40±75.88 ml after treatment from the baseline of the test group (291.66±70.50 ml; P <0.001) and placebo (226.66± 149.84 ml; P<0.008). The secondary outcome measures of the test group were significant statistically. This herb is efficacious, safe and cost effective in augmenting lactation in PIM supply. Keywords Gossypium herbaceum Linn . Perceived insufficient milk (PIM) supply . Randomized controlled trial . Galactagogues Introduction Breast milk is very important for neonates. According to a WHO/UNICEF, more than one million infants worldwide die every year because they are not breastfed or given other foods too early (Gupte 2004). Breast feeding is instinctive and most mothers adapt to it naturally (Gurneesh and Ellora 2009). The value of breast milk in developing countries like India cannot be neglected (Mathur et al. 1992). However, at the slightest problem encountered, mothers switch readily over to top/supplementary feeding. Mother often feels that they have insufficient milk (Gurneesh and Ellora 2009), and faces numerous physical, emotional and logistical obstacles to breastfeeding and even small anxieties about milk supply can lead to lactation failure (Mathur and Dhingra 2009). Perceived Insufficient Milk (PIM) supply is one of the reasons mentioned most often by women throughout the world for the early discontinuation of breast feeding and/or for the introduction of supplementary bottles (Segãoera- Millãn et al. 1994; Kent et al. 2012). The incidence of PIM S. Manjula : A. Sultana (*) Department of Amraze Niswan wa Ilmul Qabalat (Obstetrics and Gynecology), National Institute of Unani Medicine, Kottigepalya Magadi Main Road, Bangalore 560091 Karnataka, India e-mail: drarshiya@yahoo.com S. Manjula e-mail: prasad_14j@yahoo.co.in K. Rahman Department of Ilmus Saidla (Pharmacy), National Institute of Unani Medicine, Bangalore, Karnataka, India e-mail: r.khaleeq@yahoo.com Orient Pharm Exp Med DOI 10.1007/s13596-013-0121-7