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PR · Lens · An Open‑Label, Multi‑Center, Prospective, Interventional, Clinical Study to Evaluate the Efficacy and Safety of Ayuvigo Forte Capsules in Patients Suffering from Oligospermia

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Article · Volume 11, Issue 3 · pp. 290–294

An Open‑Label, Multi‑Center, Prospective, Interventional, Clinical Study to Evaluate the Efficacy and Safety of Ayuvigo Forte Capsules in Patients Suffering from Oligospermia

Sanjay M Tamoli1, Narendra B Mundhe2, Devdatta A Deshmukh3, Shishir Purushottam Pande3, Rahul Ramkrushna Kamde2, Vidyadhar S Kumbhar4, Sachin Anil Upasani1, Swapnali B Mahadik1

  1. 1Department of Medical Research, Target Institute of Medical Education and Research, Malad (West), Mumbai, Maharashtra, INDIA.
  2. 2Department of Kayachikitsa, K.V.T.R. Ayurveda College, Boradi, Maharashtra, INDIA.
  3. 3Ayurveda Research Centre, Ayurved Seva Sangh Nasik, Nashik, Maharashtra, INDIA.
  4. 4Sunad Ayurved Center, Pune, Maharashtra, INDIA.

Abstract

Background: Oligospermia refers to semen with a low concentration of sperms. Oligospermia is one of the common causative factors of male infertility.Objectives: The objective of this study was to assess the efficacy and safety of Ayuvigo forte capsule in patients suffering from oligospermia.Materials and Methods: This was an open‑label, prospective, interventional, multi‑center clinical study. A total of 30 patients were completed the study. All patients were advised to consume two Ayuvigo forte capsules twice daily orally after meals with a cup of milk for 90 days. Data describing quantitative measures are expressed as a mean ± standard deviation.Results: The mean total sperm count, mean progressive sperm motility, and total number of spermatozoa increased significantly (P < 0.05) by 90.54%, 33.65%, and 98.88% at the end of the study, respectively. Most patients had shown significant (P < 0.05) improvement in subjective parameters of low sperm count assessed as per Ayurveda. Furthermore, significant (P < 0.05) improvement was observed in mean serum free testosterone level. No statistically significant (P > 0.05) changes were observed in mean serum luteinizing hormone, follicle‑stimulating hormone, prolactin, safety laboratory parameters, and vitals. Excellent overall efficacy and tolerability were observed in majority of patients.Conclusion: Ayuvigo forte capsule is safe and effective for the management of oligospermia.

Keywords: Ayuvigo forte capsule; Oligospermia; Sperm count; Sperm motility; Testosterone level

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