A randomised clinico-comparative trial to evaluate the efficacy of Kapikacchu churna and Vidari churna in the management of ksheensukra(Oligozoospermia)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- the basis of improvement in the sperm count
研究概览
简要总结
Ksheenshukra is included in one of the varieties of Ashtavidha Shukra Dusti , Where Ksheen means decrease in amount or quality and Shukra is the 7th(terminal) Dhatu.According to acharya sushrut it is vata-pita origin.Lakshanas of Ksheenshukra according to Acharya charaka are weakness, dryness of mouth, pallor, lassitude, exertion, impotency and non- ejaculation of semen. And according to Acharya Sushrutaare pain in the penis and testes, incapacity for copulation, delayed ejaculation and semen being scanty and mixed with blood.Oligozoospermia can be the result of many factors, some are permanent and some are reversible.
Causes of Oligozoospermia include an obstruction of the normal flow of sperm due to such conditions as testicular trauma and vasectomy, from infection and sexually transmitted diseases. Other causes are reduced synthesis of testosterone or defective release of FSH and LH from pituitary. As per the principle of Ayurveda, aphrodisiac recipes should be administered after purifying the body . Hence, before administrating in all the registered cases Mridu Shodhana with Haritakyadi Yoga as per classical method will be done. Taking these points into consideration, present study is being planned to evaluate the role of Kapikachhu Churna and Vidari Churna on seminal parameters with special focus on oligozoospermia and possible effect of this trial drug on the hormones FSH, LH and Testosterone levels, which also contribute in spermatogenesis.
Total no of patient is 68 ,34 in each group.In group A Kapikachhu churna will be given in dose of 3 gm twice a day half an hour before having a meal with 300 ml of milk.In group B Vidari churna is given in dose of 3 gm twice a day half an hour before having a meal in with 300 ml of milk.
Study design is single centerd ,open label,randomised,interventional type,comparative study
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 21.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •Age 21 to 45 years of male Sperm count less than 15 million per ml according to WHO2010 Subjects who are Yogya for Mridu Virechana Subjects who are ready to sign the informed consent Subjects who are not registered in any other research project Subjects who can take medicine orally.
排除标准
- •Age below 21 and above 45 years.
- •Sperm count greater then 15 million per ml Patients of azoospermia and aspermia Patients of various diseases like varicocele, accessory sex gland infection sexually transmitted diseases, severe systemic diseases etc Genetic disorders like Klinfelters syndrome.
- •Taking treatment for major psychiatric problem History of previous medications and trauma leading to oligozoospermia Subjects suffering from Tuberculosis, Diabetes mellitus, Hypertension and Inflammatory bowel disease Subjects who are not Yogya for Mridu Virechana.
- •Subjects who are not ready to sign the informed consent Subjects who are registered in any other research projerct.
结局指标
主要结局
the basis of improvement in the sperm count
时间窗: 60 days
The efficacy of the treatment will be assessed on
时间窗: 60 days
次要结局
- Enhancement of fertility rate(Day 1)