Efficacy of Kaunchadi Granules in Ksheena Shukra W.S.R. to Oligospermia - An Open Labelled Randomized Standard Control Clinical Trail
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- To improvement in parameters of Semen Analysis
研究概览
简要总结
Kshinashukra is a burning problem of today’s era which not only affects the somatic part of body but also affect psychological health. Kshinashukra is variety of Shukradushti eventually leading to infertility and the same in biomedicine is referred as oligospermia. As per Ayurveda, oligospermia can be co-related with Kshinashukra. The prevalence of infertility in general population affects around one in eight couples of reproductive age, with a male factor being solely responsible in 20% and contributory in an additional 30% of cases.
The drugs that are selected in this research are Kaunchadi Granules which are selected as trial drug. And tablet clomiphene citrate standard drugIn Kshinashukra mainly involvement of Vata Dosha. Kaunchadi Choorna possesses Vrishya property.Guptaphala *(**Kauncha)***and Gokshurahave Madhura Rasa, Guru, Snigdha Guna, Seeta Veerya, Vrishya, Rasayana, Brimhana and Vattapittahara properties. Uchchata (Bhumyamalaki) has Madhura, Tikta, Kashaya Rasa, Laghu, Ruksha Guna, Sheeta Veerya and Balya. Milkhas Madhura Rasa, Guru, Snigdha Guna, Sheeta Veerya, Madhura Vipaka, Rasayana, Brimhana, Vattapittahara and Sharkara is having properties *ofMadhura, Sheeta Veerya, Satmya, Shukravardhaka, Balya, Jeevaniya.*All drugs have Vatapittahara propertywhich helps in Samprapti Vighatana of Ksheena Shukra as it is Vatapitta predominant disease. However, Madhura Rasa, Snigdha, and Guru Guna increase the Shukra Dhatu qualitatively and quantitatively. It can increase the Testosterone by increasing the luteininzing hormone and the gonadotropin releasing hormone. Combination of drugs having adaptogenic, antioxidant, and aphrodisiac properties effectively have multifaceted sexual health benefits.
The following investigations will be carried out before & after treatment to rule out other pathogenesis and assessment the status of subjects. Semen Analysis- (Physical examination, Microscopic examination, Other abnormalities), Hematological Examination - Hb%, TLC, DLC, ESR, Urine –Albumin, Sugar & microscopic, Bio-chemical investigation- RBS, Sr.Testosterone test and Serology Examination (HIV, HBsAg, HCV, VDRL),special laboratory test (FSH, LH, TSH) USG of Abdomen and Pelvis, Scrotum (Only BT). The participation in this research is entirely voluntary. In this present research work, 30 clinically diagnosed patient of Ksheenashukra (Oligospermia) will be registered and randomly divided into two groups. In Group A, Patients will be given Kaunchadi Granules (trial drug) every morning before breakfast, orally, 12 grams with milk twice a day for 90 days.
In Group B, Clomiphene citrate tablet orally, 1 tablet (25 mg) with water once a day after food for 90 days. The patient will be withdrawn from study if patient complains of any adverse reaction or having any serious complications occur due to treatment will be referred to the higher centre. The patient will be withdrawn if patient desires to be discontinued treatment protocol. If any adverse drug reaction will be observed then it will be reported to the ADR cell (Pharmacovigilance cell of ITRA, Jamnagar).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 21.00 Year(s) 至 45.00 Year(s)(—)
- 性别
- Male
入选标准
- •Patient willing to participate in study for 3 months with monthly follow up,Patient having sperm concentration less than 15 million/ml,Patient having sperm concentration along with decreased motility less than 50% & abnormal morphology and volume,Patient having normal thyroid function,Patient with or without clinical presentation of Ksheena Shukra like Daurbalya, Mukhashosha.
排除标准
- •Patient suffering from primary or secondary Azoospermia or Aspermia,Patient having history of Male reproductive accessory gland infection, varicocele,Patient having history of previous scrotal or inguinal surgery,Patient having history of Testicular torsion, cryptorchidism,Penile trauma or Penis fracture (rupture of corpus cavernosum),Traumatic and non- traumatic spinal disorders,Patient Taking Cytotoxic drugs, alpha-blockers and spironolactone,Genetic disorders like Klinefelter syndrome,Patient taking treatment for major psychiatric illness,Patient known case of Hypertension (BP more than150/90 mmHg) and Diabetes mellitus (RBS more than 140 mg/dl), COPD, CKD, cardiac diseases, liver diseases, and Chronic Sinusitis,Patient known case of sexually transmitted diseases like Syphilis, Gonorrhea, HIV/AIDS.
结局指标
主要结局
To improvement in parameters of Semen Analysis
时间窗: 12 weeks
次要结局
- Changes in Hormonal Assay.(To improvement in the quality of life & in score of IEEF Questionnaire)
研究者
Kamal Kumar Sidar
Institute of Teaching and Research in Ayurveda Jamnagar
