Enhancement of Male Infertility by using Dried Moringa Seeds with Velvet Beans and Safed Musli capsule - A randomized clinical trial

Introduction:

The male reproductive system consists of the internal structures: the testes, epididymis, vas deferens, prostate, and the external structures: the scrotum and penis. These structures are well-vascularized with many glands and ducts to promote the formation, storage, and ejaculation of sperm for fertilization, and to produce important androgens for male development. The major male androgen is testosterone, which is produced from Leydig cells in the testes (Gurung, P., Yetiskul, E., & Jialal, I. (2022), that maintain male reproductive function and promote spermatogenesis and transport into the female reproductive system for fertilization. The testes act as both endocrine and exocrine organs in that they are responsible for androgen production and sperm production and transport (Gurung, P., Yetiskul, E., & Jialal, I. (2022).

Common tests of male reproductive function include a blood test to measure testosterone levels. Total testosterone ranges from 300 to 1000 ng/mL. Other tests include semen analysis, which establishes fertility status and function of the seminiferous tubules, epididymis, and accessory sex glands.

Background and Purpose of study:

Disorders of the male reproductive system typically result from decreased testosterone levels or insensitivity to testosterone, which lead to low libido, failure to ejaculate, decrease in bone density, muscle loss, infertility, loss of body hair and, importantly, incomplete sexual development if the disorder is congenital or acquired before puberty. Other less specific symptoms of low testosterone include low energy/depressed mood, anemia or increased body fat. Other comorbidities associated with low testosterone include metabolic syndrome, insulin resistance, and atherosclerosis (Gurung, P., Yetiskul, E., & Jialal, I. (2022).

**Prevalence:**In the elderly, testosterone deficiency is associated with low bone mass and therefore imply an increased risk of osteoporotic fractures (Aggarwal, V., Menon, A. S., & Verma, V. (2022). Chronic and severe alcohol dependence increases the chances of developing sexual dysfunctions (Bhainsora, R. S., et all. (2021). The prevalence of Erection Dysfunction is high among T2 DM patients (Talwar, V., & Talwar, G. (2021).

Role of Diet in Male reproductive system: Environmental and lifestyle factors, diet, exposure to radiation and several other factors may affect the male reproductive system. It is evident that most of these factors contribute to male infertility via induction of oxidative stress (Agarwal, A.,et al (2020).  The mammalian system needs a continuous supply of certain trace elements, one of which is Se. In addition to other vital functions, Se is involved in male reproduction. The morphology of male reproductive organs strongly depends upon the adequate dietary supply of Se (Ahsan, U., et al. 2014) One study done on diabetic rats stated that Intake of ginger roots improves the antioxidant and androgenic reproductive function of male diabetic rats in addition to its anti-diabetic property (Ghlissi, et al. 2013).

One study done by Varsha S. Zade, et al in 2013 on albine male rats by giving them aqueous extract of the seeds M. oleifera confirms that ingestion of aqueous extract of moringa seeds produce increased effects on fertility and reproductive system in adult male rat. It also lends support to the claims for traditional usage of M. oleifera as a sexual function enhancing medicine. Thus, this study may prove to be an effective and safe alternative remedy in sexual disorders. Work is in progress on the isolation and characterization of the spermatogenic principle in the plant extract.

Thus we have seen that there are many health benefits of Moringa oleifera seeds, but appropriate processing methods should be adopted on M. oleifera seeds to reduce or eliminate the anti-fertility components or contraindications thereby making it a more acceptable food product (Anagonye Callistus, O. (2017).

Finally, the seeds of M. oleifera contain numerous phytochemical compounds with pharmacological activity. However, this activity is reported in the literature only for animal and cellular models, there has been no study of their pharmacological activity in humans. Therefore, we will conduct a clinical trial with nutrition intervention by dried moringa seeds powder in impaired Male reproductive system patients with the purpose of whether there is any improvement in male reproductive system disorders.