Effect of Asparagus racemosus (Shatavari root) on prolactin hormone: A clinical study
by Forest Raga January 12, 2021
The present study was carried out to investigate the efficacy and safety of the Asparagus racemosus (Shatavari root) on the prolactin hormone
Objective: To examine the effect of Asparagus racemosus (Shatavari root) on the prolactin hormone
Treatment Offered
Initially, 70 subjects were selected for this study, out of which 60 were finally followed up. These subjects were randomly allocated to one of the two equal-sized treatment groups and received the treatment dose of 60 mg Kg-1 body weight per day. The treatment groups included group R (research group) which received the root powder of the research drug (60 mg Kg-1 body weight per day) and group C (control group) who were administered rice powder as placebo (60 mg Kg-1 body weight per day). The treatment consisted of oral ingestion of the treatment drug in the form of capsules three times daily with milk for 30 days. All the subjects were advised to immediately discontinue the use of the drug in case of any serious side effects.
The study medication was provided in white paper boxes, numbered consecutively with a medication number. The treatment allocation schedule was based on computer-generated random numbers. The treatment codes resided with the principal investigator and the local investigators were not aware of treatment assignments. No treatment code was broken before the last follow-up visit completion.
All the subjects were advised to lead their normal lives with their family during the study period subject to the following conditions: (I) no use of any contraceptive pills or steroid containing drugs which could affect the normal hormonal balance, (II) normal feeding technique and schedule for infants, (III) making sure of the babies burping after the feeding and (IV) avoiding any situation or events which could cause abnormal anxiety or tension. Follow-up visits were done weekly to undertake the physical examination of mother and child and for analysis of their symptoms.
Outcome measures
The primary outcome measure in this study was the biochemical estimation of prolactin hormone levels before and after the treatment. To that end, a 2 mL sample of blood was drawn from each subject to ascertain the initial and final level of prolactin hormone level during the clinical study. The quantitative determination of prolactin hormone concentration (ng/mL) in human serum of blood sample was done by Microplate Immunoenzymometric Assay (ELISA) technique at Ashoka laboratory, Kolkata using the kit of monoband. Inc.
The secondary outcomes measured during this study were the changes in mothers weight, babies weight, subjective satisfaction of mothers regarding the state of lactation, and the well-being and happiness of babies. The mothers weight and babies weight were recorded just before and after the period of a clinical trial. The subjective satisfaction of mothers regarding the state of lactation and the well-being and happiness of babies were rated on a graded scale ranging from 1 to 5 (1 denoting unsatisfactory and 5 representing highly satisfactory).
Statistical analysis
The results were analyzed statistically using the students t-test. The values of p < 0.05 were considered statistically significant, p < 0.01 were considered very significant and the values of p < 0.001 were taken as highly significant.
Results
General information
A total of 60 subjects were randomized and received trial medication after providing the written agreement of their participation in the trial. The mothers were of an average age of 25.6 years while the average age of infants was 2.8 months. 79% of the patients belonged to the minority Muslim community, while 71% resided in an urban or semi-urban area. There was no significant group difference concerning the distribution of age, community, or habitat. A total of 10 patients, who did not participate in the entire trial or did not turn up for regular follow-up visits, were excluded from the study.
Acute oral toxicity
No signs of oral toxicity were observed during the short-term analysis in mice but mortality was noticed in the long-term study at the dose of 5000 mg/Kg.
Evaluation of increase in prolactin hormone level
The mean prolactin hormone level of the subjects showed a percentage increase of 32.87 ± 6.48 through the study period in the case of the research group (group R) while the control group (group C) showed a percentage increase of only 9.56 ± 4.57 in the mean prolactin hormone level during the same period as detailed in Table 1.
Table 1
Mean percent increase in primary and secondary parameters during the clinical trial
n = 20 a: p < 0.05 b: p < 0.01 c: p < 0.001
The obtained results proved to be statistically significant (p < 0.05) using the 2-tailed t-test
The results of the clinical study showed that the oral administration of the research drug had a definite positive impact on the primary parameter, the prolactin hormone level in the lactating mothers. The increase in the mean prolactin hormone level of the subjects in the research group was three times more than that of the subjects in the control group (or more) during the study period. The findings in respect of the primary parameter are also corroborated by the results in the case of the secondary outcome measures. Thus, while the measured secondary parameters, namely the weight of the mothers and the weight of the babies, showed substantially higher increases in the research group as compared to the control group, the rated secondary parameters, namely the subjective satisfaction of mother regarding the state of lactation and the well-being and happiness of babies, also showed a manifold increase in the overall ratings over the duration of the study in the research group subjects when compared to the control group. The research drug was also found to be quite safe from the viewpoint of acute oral toxicity. The statistical analysis of the results showed that the findings were statistically significant (p < 0.05).
Conclusion
Evaluation of the galactagogue action of the roots of Asparagus racemosus Willd. during the clinical trial on lactating mothers having symptoms of deficient lactation exhibits significant galactagogue activity in comparison with the control group without any significant acute toxicity effect. A probable reason for this galactagogue effect could be the presence of steroidal saponins in this plant. This drug has been scientifically validated for its galactagogue activity by using modern parameters such as the prolactin hormone which is biochemically responsible for lactation and also other associated symptoms. The overall research findings corroborate and validate the galactagogue activity of the research drug, which has been traditionally ascribed to it in the ancient text Charak Samhita.
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