Safety and Efficacy of Chandrakanthi Choornam in Oligospermia - A Preclinical and Clinical Study
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
- Botanical Identification
- Chemical Identification
- 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
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Chandrakanthi choornam
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
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
