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.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 3
- 主要终点
- Change in the serum total testosterone levels and free testosterone levels from baseline to the end of 90 days compared across two conditions (placebo and test product)
研究概览
简要总结
It is a doubleblind placebo controlled multicentric study to assess the effect of 100mg and200mg Physta® on total testosterone, free testosterone level and quality oflife in subjects having low testosterone level. Physta®, is a patentedproprietary water-soluble standardized extract derived from Malaysian Eurycoma Longifolia roots. E. Longifolia is reported to haveaphrodisiac property, contributed by its testosterone enhancing effect. Insteadof containing testosterone itself, E.longifolia works by promoting the production of testosterone naturally. E. Longifolia extract also possesspotent antimalarial activity, especially the activity against thechloroquine-resistant Plasmodium falciparum. Moreover, E. Longifolia exerts proandrogenic effects that enhance thetestosterone level, as well as stimulate osteoblast proliferation andosteoclast apoptosis. This will maintain bone remodeling activity and reducebone loss and thus possess osteoporosis preventive effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Male
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 <90mmHg) 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.
结局指标
主要结局
Change in the serum total testosterone levels and free testosterone levels from baseline to the end of 90 days compared across two conditions (placebo and test product)
时间窗: At screening, day 14, day 30, day 60 and Day 91
次要结局
- Change in the BMI (Body Mass Index) from baseline to the end of 90 days compared across two conditions (placebo and test product)(At screening or randomization, day 14, day 30, day 60 and Day 91)
- Change in total score on the quality of life questionnaires including AMS (Aging Male Symptoms Score) and FSS (Fatigue Severity Scale) from baseline to the end of 90 days compared across two conditions (placebo and test product)(At randomization, day 14, day 30, day 60 and Day 91)
- Change in the levels of SHBG (Sex hormone binding globulin) and DHEA (Dehydroepiandrosterone) from baseline to the end of 90 days compared across two conditions (placebo and test product)(At screening or randomization, day 14, day 30, day 60 and Day 91)
- Change in the levels of HBA1C, IGF-1, Thyroxin Profile (T3, T4 & TSH), Free T3, Cortisol and muscle tone from baseline to the end of 90 days compared across two conditions (placebo and test product)(At screening or randomization and Day 91)