Effects of Shatavari on galactogogue activity: A clinical study
The present study was carried out to investigate the effects and safety of Effects of Shatavari on galactagogue activity
Treatment Offered
This clinical trial was a double-blind, randomized, placebo-controlled, parallel-group study involving a total of 60 subjects. The study was carried out at the medical outdoor patient's clinic department of the Institute of Post Graduate Ayurvedic Education and Research at the S. V. S. P. Hospital, Kolkata.
Preparation of the research drug and its administration
Fresh roots of Asparagus racemosus Willd. were collected from a reputed herb supplier of Kolkata. These were authenticated and identified by the department of ethnobotany, botanical survey of India, shipper, Howrah. A voucher specimen (No. BM/UCM/007) was deposited in the herbarium before their utilization. The roots were cleaned, dried in shade, and fine-powdered up to 80 mesh size. The root powder was put into capsules depending on the body weight of each subject and labeled €œR€. Similarly placebo capsules were prepared with fine rice powder and labeled €œC€.
Acute oral toxicity
Acute oral toxicity refers to the adverse effects that occur following oral administration of a single dose of a substance or multiple doses given within 24 h. OECD Guideline No. 425 (acute oral toxicity-acute toxic class method) was undertaken as a test procedure to ascertain the acute oral toxicity. In addition to the estimation of LD50 and confidence intervals, the test allows observing the signs of toxicity. Six groups each containing six swiss albino mice weighing 25-30 g maintained in standardized environmental conditions (animal house Reg. No. 1180/ac/08/CPCSEA) were fasted 12 h before the experiment and administered the drug sample orally in the dose of 300 mg/Kg, 500 mg/Kg, 1000 mg/Kg, 2000 mg/Kg and 5000 mg/Kg in 1 mL of the aqueous solvent. The physical activity, behavior, and mortality of each mice of each group is observed and recorded after 1/2 h, 2 h, 4 h, 8 h, 12 h, 24 h, and 48 h.
Subjects
All the subjects were lactating mothers who were selected after general examination from the medical outdoor patients' department of the Institute of Post Graduate Ayurvedic Education and Research at the S. V. S. P. Hospital, Kolkata using the following inclusion criteria: (I) age of mother between 20-40 years; (II) age of infant up to 6 months; (III) having one or more of the following symptoms: deficient lactation, infant€™s crying just after feeding, painful sensation in breasts during the time of feeding, loss of appetite in mother or the manifestation of any anxiety disorder which could affect the lactation.
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 with regard to 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 a 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
| Parameter |
Mean percent increase |
|||
|---|---|---|---|---|
| Group R | Group C | |||
| Primary outcome: | ||||
| Mean prolactin hormone level | 32.87 ± 6.48 a | 9.56 ± 4.57 a | ||
| Secondary outcomes: | ||||
| Mean weight of mother | 3.78 ± 0.68 a | 1.37 ± 0.44 a | ||
| Mean weight of babies | 16.13 ± 3.65 a | 5.68 ± 2.57 a | ||
| Subjective satisfaction of mother | 1.54 ± 0.28 a | 0.48 ± 0.33 a | ||
| Overall well-being & happiness of babies | 1.27 ± 0.45 a | 0.29 ± 0.23 a | ||
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
Conclusion
Evaluation of the galactagogue action of the roots of Asparagus racemosus Willd. during clinical trial on lactating mothers having symptoms of deficient lactation exhibits significant galactogogue activity in comparison with the control group without any significant acute toxicity effect. A probable reason for this galactogogue effect could be the presence of steroidal saponins in this plant. This drug has been scientifically validated for its galactogogue 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 galactogogue activity of the research drug, which has been traditionally ascribed to it in the ancient text Charak Samhita.
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