CTRI/2019/03/017959已完成2 期
A double blind placebo controlled multicentric study to assess the effect of 100mg and 200mg Physta® on total testosterone, free testosterone level and quality of life in subjects having low testosterone level. - SPOT
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 105
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Age 50-70 years, Male
- •2.BMI>=18 and <=30.0 kg/m2
- •3.Testosterone levels <300 ng/dL
- •4.In a stable heterosexual relationship for at least 6 months
- •5.Volunteer must be able, willing and likely to fully comply with study procedures and restrictions.
- •6.Judged by the investigator to be in general good health on the basis of medical history.
- •7.Volunteer agree to not to take any other product which can boost testosterone during study period
- •8.Volunteer willing to sign the informed consent
排除标准
- •1.History of prostate cancer
- •2.Abnormal prostate exam (induration, asymmetry, or nodules)
- •3.Benign Prostate Hyperplasia symptoms
- •4.Penile anatomical abnormalities
- •5.Premature ejaculation
- •6.Cardiovascular disease
- •7.Resting hypotension (resting systolic blood pressure
- •8.Resting hypertension (resting systolic blood pressure
- •>170mmHg or diastolic pressure >110mmHg)
- •9.Primary hypoactive sexual desire
- •10.Volunteer taking any other investigation drug and currently being a part of any other clinical trial/research.
- •11.Any other underlying conditions which might affect serum testosterone levels (total and free).
- •12.Volunteers with known hypersensitivity to test drug or any of the excipients of this extract
- •13.Abnormal /Elevated kidney & liver function test
- •14.High alcohol intake ( > 2standard drinks per day)
- •15.History of depression
- •16.Uncontrolled Diabetes
- •17.History of Seizures
- •18.Clinically significant chronic hematological disease
- •19.Significant active peptic ulceration
- •20.History of syncope within the last 6 months prior to entry to the study
- •21.History of malignancy within the past 5 years
- •22.Any congenital spinal cord deformities or traumatic spinal cord injuries
- •23.Any congenital or traumatic brain injuries
研究者
相似试验
进行中（未招募）
1 期
A clinical trial to assess efficacy and safety of Alvalin® (active agent) vs. placebo (inactive substance) in 265 obese patients/group with a body mass index (BMI) between 30 and 45 kg/m2. Neither the investigator nor the participant are aware of the nature of the treatment the participant is receiving. The trial is conducted in several trial centres.diet-related obesity diagnosed by BMI of 30 to 45 kg/m²EUCTR2012-003426-24-DERiemser Pharma GmbH
进行中（未招募）
不适用
A multicentre double blind placebo controlled clinical dose- finding study for three doses of Antiadipositum X 112 T® (Cathine-hydrochloride) vs. placebo in 240 patients with a body mass index (BMI) between 27 kg/m2 and 40 kg/m2 - X 112 dose-finidngdiet-related obesity diagnosed by BMI of 30 to 40 kg/m² or diet-related obesity diagnosed by BMI of 27 to 40 kg/m² in patient with coexisting risk factors like hyperlipidaemia, type 2 diabetes mellitusEUCTR2009-010116-15-DERIEMSER Arzneimittel AG240
进行中（未招募）
不适用
A double-blind, placebo controlled multicentre study to evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis. - MAESTRO-01Secondary progressive multiple sclerosisMedDRA version: 8.1Level: LLTClassification code 10063400Term: Secondary progressive multiple sclerosisEUCTR2004-002571-16-EEBioMS Technology Corp553
进行中（未招募）
不适用
A double-blind, placebo controlled multicentre study to evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis. - N/ASecondary progressive multiple sclerosisMedDRA version: 8.1Level: LLTClassification code 10063400Term: Secondary progressive multiple sclerosisEUCTR2004-002571-16-LTBioMS Technology Corp553
进行中（未招募）
不适用
A double-blind, placebo controlled multicentre study to evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis. - MAESTRO-01Secondary progressive multiple sclerosisMedDRA version: 8.1Level: LLTClassification code 10063400Term: Secondary progressive multiple sclerosisEUCTR2004-002571-16-GBBioMS Technology Corp553