Randomized double blind parallel arm placebo controlled study to evaluate the effect of Nagavallyadi Churna on IELT, patient reported outcome and safety in men with Premature ejaculation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- the efficacy of Nagvalyadi Churna with respect to duration of IELT
研究概览
简要总结
This is a Randomized doubleblind parallel arm placebo controlled study to evaluate the efficacy, safety ofNagavallyadi Churna on both life long and acquired premature ejaculation. This wellcontrolled PE RCT methodology includes Placebo control. The Nagavllyadi churnais being evaluated for the first time in a placebo controlled trial, the number of subjects that must be enrolled is relatively small andconsequently the number of non-responders is also small.
Initially in screening phase it is also treatment freephase subjects will be screened for inclusion criteria and randomization willbe done. In treatment phase subjects will be allocated for treatment by doubleblinding method with a follow of four visits. In the post-trial phase subjectswill be interrogated for residual adverse effect and data will be collected,the collected data will be analysed and assessment will be done by usingappropriate stastical methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Male subjects aged ≥18 years 2.Subject has to provided written informed consent(Annexure-4 ) 3.Subjects must be in a stable, monogamous, sexual relationship with the same partner for at least 6 months and plan to maintain this relationship for the duration of the trial.
- •4.Subjects with the same sexual orientation and partner gender Preference.
- •5.Acceptance to attempt intercourse on a regular basis and at least once a week.
- •6.Non-pregnant partners.
- •7.Subjects must be in good general health with no clinically relevant abnormalities, normal blood chemistry, testosterone, CBC, urinalysis, and 12-lead ECG 8.Subjects must meet criteria for diagnosis of PE using a multivariate definition of PE and a baseline trial specific threshold ejaculatory latency time, e.g., intravaginal ejaculatory latency time (IELT).
- •9.Subjects must meet criteria for diagnosis of PE with a PEDT score ≥11 indicates.
排除标准
- •1.Use of any investigational drug within the past month or within a period of five times the drug half-life, if it is longer.
- •2.Any significant somatic disorder.
- •3.Any potential neurologic, urologic, or endocrine cause of PE.
- •4.Any current or previous psychiatric disorder.
- •5.Current or previous alcohol or psychoactive substance abuse or dependence.
- •6.Use of any medication that could cause sexual dysfunction.
- •7.Any other sexual dysfunction including ED.
- •8.Untreated hypogonadism, hyperprolactinemia, or hyper- or hypothyroidism.
- •9.Clinically significant sexual dysfunction of the partner.
- •10.Subject with hypoactive sexual desire, retrograde, delayed or absent orgasm or ejaculation or ED (IIEF-5 >21) (Annexure -1).
结局指标
主要结局
the efficacy of Nagvalyadi Churna with respect to duration of IELT
时间窗: safety and tolerability | change in IPE will be assessed in every week of treatment phase
safety and tolerability
时间窗: safety and tolerability | change in IPE will be assessed in every week of treatment phase
change in IPE
时间窗: safety and tolerability | change in IPE will be assessed in every week of treatment phase
次要结局
- safety and tolerability(change in IPE)