单盲安慰剂对照临床研究评价思达堇叶的疗效。使用精液和激素分析来治疗精液紊乱(Sukra Kshaya)

M. Gupta, A. Mondal
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引用次数: 1

摘要

背景:Sida cordifolia Linn。是一种著名的药用植物,具有抗炎、抗氧化和性特性。在临床前研究中显示出治疗男性性功能障碍的良好前景。目的:研究菖蒲根水提物的生精作用。在临床试验中。材料与方法:本研究采用原发、继发症状等定性标准,血液学调查、激素分析、精液分析等定量调查,通过安慰剂对照临床试验,对50名性欲不足、性生活不满意的男性进行研究配方的疗效评估。结果:研究组在性欲减退、射精困难或精液少等主要症状以及恶心、体痛、头痛、消化不良、食欲不振、全身乏力等继发症状方面均有很高的抑制作用。血液学参数(血糖、血红蛋白、ESR、RBC和WBC)和生化参数(胆红素、蛋白质、SGPT、SGOT和ALP)没有任何不良变化,表明研究制剂是无毒的。研究组在临床研究过程中激素水平显著升高,其中睾酮水平升高幅度最大(8.53%)。通过精子数量、活力和形态评估的精液质量在研究组中显示出显著的改善,这表明在与压力相关的性问题中给予研究药物通过减少ROS的产生来保护健康细胞,并有助于维持精子在精子发生过程中的质量参数。结论:以堇青花根为原料制备复方。通过抑制原发性和继发性症状,提高激素和精液参数,显示出良好且显著(P < 0.05)的治疗效果,验证了其生精作用,无任何毒副作用。
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Single-blind placebo-controlled clinical study to evaluate the efficacy of Sida cordifolia Linn. in treatment of semen disorders (Sukra Kshaya) using semen and hormonal analysis
Background: Sida cordifolia Linn. is a well-known medicinal plant which exhibits anti-inflammatory, antioxidant, and sexual properties. It shows good promise in the treatment of male sexual disorders during its pre-clinical studies. Objective: The objective of the study was to assess the spermatogenesis action of aqueous extract of roots of S. cordifolia Linn. in clinical trials. Materials and Methods: The study uses qualitative criteria such as primary and secondary symptoms, and quantitative investigations such as hematological investigations, hormonal analysis, and semen analysis for assessing the therapeutic efficacy of research formulation through placebo-controlled clinical trials on 50 males having lack of sexual desire and non-satisfactory sexual life. Results: Very high inhibition was noticed in respect of primary symptoms such as lack of libido, difficulty in ejaculation or little amount of semen, as well as secondary symptoms such as nausea, body ache, headache, indigestion, loss of appetite, and general weakness in the research group. Lack of any adverse changes in hematological parameters (blood sugar, hemoglobin, ESR, RBC, and WBC) and biochemical parameters (bilirubin, protein, SGPT, SGOT, and ALP) indicates the non-toxic nature of research formulation. The hormonal levels registered a significant increase during the clinical study in research group, especially the testosterone level (8.53%). Semen quality evaluated through sperm count, motility, and morphology showed a significant improvement in research group, suggesting that administration of research drug in cases of stress-related sexual problems protected healthy cells by reduced generation of ROS and helped maintain quality parameters of spermatozoa during spermatogenesis. Conclusion: The research formulation made from roots of S. cordifolia Linn. shows good and significant (P < 0.05) therapeutic efficacy through inhibition of primary and secondary symptoms and enhancement in hormonal and seminal parameters, validating its spermatogenesis effect without any toxic or adverse effects.
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