A CLINICAL STUDY TO EVALUATE THE EFFICACY OF MASHADI GHRITA IN KSHEENA SHUKRA (OLIGOSPERMIA)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- After the treatment period, the following symptoms
研究概览
简要总结
This study is Single Arm Open Label Clinical Trial with Mashadi Ghrita 5ml BD (Total 10ml) as an interventional drug for the period of 60 days.
This study is conducted on the patients of Ksheena Shukra (Oligospermia) aged 22 to 45 years with a sperm count of less than 20 million sperm/ml of semen, who gave written and legal consent to undergoing a clinical trial.
Study will be conducted in Alva’s Ayurveda Medical College and Hospital, Vidyagiri, Moodabidri.
The assessment will be done on 0th day, 31st day and 61st day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 22.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •Patients who fulfill the diagnostic criteria.
- •Patients from any religion, occupation, or socio-economic class.
- •Patients are willing to participate in the study and ready to sign the informed consent form.
排除标准
- •Male patients with absolute Azoospermia and Teratozoospermia.
- •Male patients on certain medications like antineoplastic agents (e.g., Nitrogen mustard, procarbazine, vincristine, methotrexate), cimetidine, estrogen and methyltestosterone.
- •Patients have chromosomal disorders like Klinefelter’s syndrome.
- •Patients suffering from major systemic disorders like Tuberculosis, AIDS and sexual Transmitted Diseases (STD) and other gonadal disorders like Testicular Atrophy, Testicular Failure and orchitis, which may interfere with study, will be excluded.
- •Patients having any anatomical deformity in gonads (e.g., Cryptorchidism, Monorchidism).
结局指标
主要结局
After the treatment period, the following symptoms
时间窗: After 60 days
will be checked.
时间窗: After 60 days
Volume
时间窗: After 60 days
Color
时间窗: After 60 days
Concentration
时间窗: After 60 days
pH
时间窗: After 60 days
Viscosity
时间窗: After 60 days
Liquefaction Time
时间窗: After 60 days
Sperm Morphology
时间窗: After 60 days
Vitality
时间窗: After 60 days
Motility
时间窗: After 60 days
Seminal Fructose
时间窗: After 60 days
Sperm Count
时间窗: After 60 days
次要结局
- After the treatment period, the following symptoms(will be checked.)
研究者
Udutha Vikrant Shreehari
Alvas Ayurveda Medical College, Moodubidre