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临床试验/CTRI/2024/07/071016
CTRI/2024/07/071016尚未招募2/3 期

AN OPEN LABEL RANDOMIZED STANDARD CONTROLLED CLINICAL TRIAL ON THE EFFECT OF SHALMALI MOOLA (Shalmalia Malabarica. L) TABLET IN OLIGOSPERMIA (KSHEENA SHUKRA)

G.J. Patel Institute Of Ayurvedic Studies and Research1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年8月7日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
To Analyze the Effect of Shalmali moola tablets on Sperm Count.

研究概览

简要总结

As high as 90% of male infertility problems are related to sperm count and there is always a positive association between the abnormal semen parameters and sperm count. But in about 30-40% cases the cause of Oligospermia is unexplained, and in the rest of the cases critical illness, malnutrition, geneticabnormalities, pollution, side effects of some medicines, hormones and chemicals play a major role. The oxidative stress caused by ROS leading to sperm dysfunction, sperm DNA damage and finally resulting in reduced male reproductive potential is an area of great concern in contemporary medicine about seminal morbidities.Considering these aspects, in contemporary medicine as a base line management the routine administration of oral anti-oxidants like L-carnitine, Coenzyme Q-10, etc is being practiced initially9. But there are no established conclusive reports on antioxidants effect in seminal parameters and also the optimal type and dosage of antioxidants are still unknown. And when there is no response to these treatments, other investigations are done and nearly all cases are being suggested for Assisted Reproductive Techniques (ART). Even though the modern science plays an important role for treating the infertility but because of their costly investments they are not reaching to the poor or middle-class people. There are growing concerns that disturbance in hormone levels results in spermatogenesis dysfunction and male infertility. Hormone deficiency in germ cell microenvironments has been indicated as the key reason for immature sperm increase which could adversely affect sperm survival and function.

The process of spermatogenesis is thoroughly dependent on downstream hormones secreted in response to gonadotropin-releasing hormone in the hypothalamus-pituitary-testis axis. FSH affects Sertoli cells to produce AMH or serves a direct fundamental role in spermatogenesis through stimulation of cell proliferation, differentiation, and control of surrounding cells apoptosis. However, LH acts on Leydig cells to promote testosterone secretion and affects spermatogenesis via testosterone/androgen. Gonadotropin and testosterone concentrations play significant roles in maintaining normal spermatogenesis receptors. Therefore, in the current study, we investigated the effects of known hormones on Oligospermia to draw a more reliable conclusion.So, in such conditions an effort has been taken to treat Ksheena shukra w.s.r to oligospermia by using Shalmali moola tablets.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
21.00 Year(s) 至 45.00 Year(s)(—)
性别
Male

入选标准

  • Diagnosed cases of oligospermia Sperm count less than 15 million/ml.

排除标准

  • Patients with azoospermia & aspermia, Teratospermia more than14%
  • Patient with known sexually transmitted disease.
  • Sperm count greater than 15 million/ml.
  • Systemic diseases like known case of diabetes mellitus will be excluded from the study.

结局指标

主要结局

To Analyze the Effect of Shalmali moola tablets on Sperm Count.

时间窗: 30 days

次要结局

  • To Evaluate the Effect of Shalmali moola Tablets on LDL, LH & S.Testosterone.(30 days)

研究者

发起方
G.J. Patel Institute Of Ayurvedic Studies and Research
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

REMESH CHANDRAN TS

CVM UNIVERSITY

研究点 (1)

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