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临床试验/CTRI/2024/10/075266
CTRI/2024/10/075266尚未招募3 期

A single blind randomized controlled clinical trial to evaluate the safety and efficacy of majun piyaz in cases of qillate mani (oligosperma)

Government Nizamia Tibbi College and General hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年10月15日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Increase in sperm count

研究概览

简要总结

The study is going to be conducted on patients with oligospermia, total sample size is 40 divided in 2 groups, group A and group B, group A will be given control drug i.e Clomiphene Citrate 25mg daily OD for 24 days with 6 days gap for 60 days. Group B will be given Majun piyaz 12 gram morning with cow milk for 60 days. Patient is assessed on day 0, day 30, day 60. The outcome is measured by semen analysis.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
25.00 Year(s) 至 55.00 Year(s)(—)
性别
Male

入选标准

  • Age between 25-55 years.
  • All socio-economical classes.
  • No past history of renal, hepatic or any other chronic illness.
  • History of unprotective intercourse for period of 12 months Infertile oligopsermia patient without any delayed puberty Infertile patient having oligospermia less than 15 million/ml of semen.
  • Patients who willing for semen examination after the treatment.

排除标准

  • Patient with complete Azoospermia in pre-samples.
  • Evidence of male accessory gland infection like orchitis, mumps, varicocele and trauma to testis, excessive radiation to the testis and uncorrected bilateral cryptorchidism.
  • Taking anti TB drugs, alpha blockers, spironolactone and any cytotoxic drugs.
  • Patients suffering with anti-immune diseases like STD, HIV.
  • Patient with diabetes mellitus,cardiac and thyroid diseases.
  • Hormone treatment for promoting fertilty in the last three months,psychologically or mentally ill patients.

结局指标

主要结局

Increase in sperm count

时间窗: Day 0,day 30,day 60

次要结局

  • Increase in male fertility(Day 0, day 30, day 60)

研究者

发起方
Government Nizamia Tibbi College and General hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Shaik Saifur Rehman

Government Nizamia Tibbi College and General Hospital

研究点 (1)

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