A Study to Evaluate Efficacy of Investigational Product HeezOn Ultra -1/ HeezOn Ultra-2 on Male Sexual Health (HeezOn-Ultra)
|ClinicalTrials.gov Identifier: NCT02794454|
Recruitment Status : Completed
First Posted : June 9, 2016
Last Update Posted : January 30, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Erectile Dysfunction Premature Ejaculation||Other: HeezOn Ultra-1 Other: HeezOn Ultra-2 Other: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Placebo-controlled, Double-blind Study to Evaluate Efficacy of Investigational Product HeezOn Ultra -1/ HeezOn Ultra-2 on Male Sexual Health|
|Study Start Date :||May 2016|
|Actual Primary Completion Date :||January 2017|
|Actual Study Completion Date :||January 2017|
Active Comparator: HeezOn Ultra-1
HeezOn Ultra-1 includes ingredients like Shilajit, Galangal, Fenugreek. Dose: 2 capsules daily half an hour before dinner to be taken orally for 21 days.
Other: HeezOn Ultra-1
Active Comparator: HeezOn Ultra-2
HeezOn Ultra-2 includes ingredients like Arjuna, Galangal, Fenugreek. Dose: 2 capsules daily half an hour before dinner to be taken orally for 21 days.
Other: HeezOn Ultra-2
Placebo Comparator: Placebo
Placebo consists of Micro-crystalline Cellulose. Dose: 2 capsules daily half an hour before dinner to be taken orally for 21 days.
- Change in scores of Sexual Health Inventory for Men [ Time Frame: Day 0, Day 1, Day 3, Day 14 and Day 28 ]
- Sexual Hormone Binding Globulin [ Time Frame: Day 0 and Day 14 ]
- Free Testosterone [ Time Frame: Day 0 and Day 14 ]
- Change in scores of Sexual Quality of Life - Male [ Time Frame: Day 0, Day 1, Day 3, Day 14 and Day 28 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02794454
|Principal Investigator:||Sandip Patil, M.D.||Maharashtra Medical Council|
|Principal Investigator:||Shirish Malde, BHMS||Maharashtra Council of Homoeopathy Mumbai|