NCT02794454

A Study to Evaluate Efficacy of Investigational Product HeezOn Ultra -1/ HeezOn Ultra-2 on Male Sexual Health

A Randomized, Placebo-controlled, Double-blind Study to Evaluate Efficacy of Investigational Product HeezOn Ultra -1/ HeezOn Ultra-2 on Male Sexual Health

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Vedic Lifesciences Pvt. Ltd. · Industry
• Sex: Male
• Age: 30 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Sexual function is a part of a normal healthy life and considered to be essential for mental, physical and marital well-being. Any derangement in normal function though is a distressing situation for the individual, is often not reported due to embarrassment or due to social stigma. Sexual disorders in men are categorized according to the stage of sexual response affected in terms of disorders of erectile function, ejaculatory function or libido, albeit there is considerable potential for overlap amongst the disorders. The use of current intervention has many side-effects and has been prohibited in cardiovascular condition and also to be taken with caution with other medical condition. This has led to the development of multiple alternate therapies which are helpful for a limited number of cases but the major concern for all these therapies is their late onset of action and not having a sustained effect.

Detailed description

Enovate Biolife is trying to improvise further their already marketed product HeezOn® by adding new botanicals thus naming it HeezOn Ultra. HeezOn®has been studied on 148 subjects and has proven to be beneficial for subjects with mild to moderate ED. The previous study fell short to capture the data for subjects who were also suffering from PE and their overall quality of life-related to sexual health. Therefore, the trial is designed to study the speedy and sustained effect of the improvised formula on different aspects of sexual dysfunctions.

Conditions

• Erectile Dysfunction
• Premature Ejaculation

Interventions

Type	Name	Description
OTHER	HeezOn Ultra-1
OTHER	HeezOn Ultra-2
OTHER	Placebo

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2016-06-09
• Last updated: 2017-01-30