Pharmaceutical analytical and clinical study of Shiva Gutika wsr to Oligospermia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- A.Subjective Criteria - A scoring pattern will be adopted for the sign and symptoms of Ksheen Shukra mentioned in Ayurvedic texts. The score of symptoms will be assessed before and after the treatment and statistical analysis will be undertaken.
研究概览
简要总结
Infertility isa common problem of present scenario. The predominant concern with populationcontrol in recent years has tended to over-shadow the importance of involuntarysterility as a medical issue. On an average about 10% of all couples facedifficulty in starting a family and this creates a feeling of great personalfailure, particularly in India where religious and socio-economic traditionshave made it almost imperative for everyone to have children.
One of the most common causeof male infertility is Oligozoospermia. The term Oligozoospermia is thepresence of an abnormally low number of sperm in a semen sample. The diagnosismethod consists of a semenogram which gives a sperm count per millimetre ofsemen. According to recent criteria of Semen Analysis generated by ICD10 N46.1sperm count less than 20 million sperms/ml is an indication of Oligozoospermia.
In Modernmedicine there are various medications used to treat Oligozoospermia includingClomiphene Citrate, Tomoxifen, Testosterone, Acetyle-L-Carnitine but they havetheir own limitations and side-effects.
There are several researches done to find a solution for this problem oftoday and many of them have proved successful too. Ayurveda provides besttreatment to combat with this problem.
Oligozoospermia resembles Ksheen Shukra in Ayurvedic literatureand Shiva Gutika consists of all the ingredients which directly work on ShukraDhatu and helps in improving its quality and quantity.
In order to generate preliminary evidences about the efficacy of ShivaGutika in the management of Oligozoospermia, a pre and post open clinicaltrial is proposed. Thirty eligible study subjects meeting inclusion criteriawith baseline sperm count less than 20 million/ml analysed through SemenAnalysis. In a single group of sample size of n= 30 will be administered 8weeks(60 days) of Shiva Gutika tablets in the dose of 500mg twice daily withluke warm milk and the treatment will be concluded with post-test assessment onthe 60th day.
Study subjects will be assessed before and after treatment forimprovement, comparison and analysis will be done by using Student’s t- Test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 21.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Male
入选标准
- •Patient Diagnosed with oligospermia as per ICD10 N46.1 Diagnostic Criteria.
排除标准
- •Patients with evidence of malignancy.
- •Current history of Ischemic heart disease,
- •Chronic kidney disease, Diabetes Mellitus, 4.High Cholesterol and any
- •Other critical illness which may require hospitalization & critical care.
- •Patients take such as medicine which has anti oligozoospermia effect also.
结局指标
主要结局
A.Subjective Criteria - A scoring pattern will be adopted for the sign and symptoms of Ksheen Shukra mentioned in Ayurvedic texts. The score of symptoms will be assessed before and after the treatment and statistical analysis will be undertaken.
时间窗: 30th day
1.Daurbalya (General Weakness)
时间窗: 30th day
2.Mukh Sosha (Dryness of mouth)
时间窗: 30th day
3. Alpa Cheshta (Lack of Libido)
时间窗: 30th day
B.Objective Criteria: - Sperm Count before and after treatment.
时间窗: 30th day
次要结局
- NA(NA)