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临床试验/NCT02234206
NCT02234206已完成2 期

Safety and Efficacy of Chandrakanthi Choornam in Oligospermia - A Preclinical and Clinical Study

Tamil Nadu Dr.M.G.R.Medical University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Proportion of Sperm morphology

研究概览

简要总结

This is an Open clinical trial to study the safety and efficacy of Chandrakanthi Choornam in 40 patients with Oligospermia. Chandrakanthi choornam is a formulation consisting of 25 ingredients. They are Curculigo orchioides -rhizome, Madhuca longifolia - flower, Cinnamomum verum -bark,Cinnamomum tamala-Leaf, Syzygium aromaticum - flower bud,Coscinium fenestratum-stem bark,Mesua ferrea-flower, Maerua arenaria-tuber, Adhatoda vasica- seed, Moringa oleifera-seed, Lawsonia inermis-seed, Vitis vinifera- fruit, Bombax ceiba- gum, Bambusa aurundinaceae-salt,Phoenix dactilifera- fruit,Ilicium verum- flower, Mucuna prurita-seed, Cyperus rotundus- rhizome, Glycyrrhiza glabra-root, Tribulus terrestris-fruit, Cuminum cyminum-seed,Costus speciosus-root,Myrsitica fragrans-seed, Alternanthera sessilis-seed and asphaltum-mineral. Treatment duration is three months.Study is conducted in India (Chennai). Primary outcome measure is to see the changes in sperm count, motility and morphology. Secondary Outcome measure is to see the impact on the harmone level.

详细描述

METHODOLOGY OF PROPOSED RESEARCH:

I. Preclinical study II. Clinical study

I. PRECLINICAL STUDY:

Standardization Of The Study Drug

  1. Botanical Identification
  2. Chemical Identification
  3. Preparation of the study drugs:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 45 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Chandrakanthi choornam

Experimental

Chandrakanthi Choornam (CKC) - 12gm in milk

OD dose; Oral route

3 Months - duration

Intervention Drug: Chandrakanthi Choornam (CKC)

干预措施: Chandrakanthi Choornam (CKC) (Drug)

结局指标

主要结局

Proportion of Sperm morphology

时间窗: 90 days

Changes in the percentage of sperm cells with normal forms were evaluated from baseline to three months

Proportion of Sperm motility

时间窗: 90 days

Changes in the percentage of total and progressive motility of sperm were evaluated from baseline to three months

Sperm concentration per milliliter of seminal fluid

时间窗: 90 days

Changes in the total number of sperm cells per milliliter of seminal fluid were evaluated from baseline to three months

次要结局

  • Impact on the hormonal level due to the clinical trial(90 days)

研究者

发起方
Tamil Nadu Dr.M.G.R.Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr.B.Akila., M.D (s)

Safety and Efficacy of Chandrakanthi Choornam in Oligospermia - A Preclinical and Clinical Study

Tamil Nadu Dr.M.G.R.Medical University

研究点 (1)

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