Clinical trial NCT02794454: A Study to Evaluate Efficacy of Investigational Product HeezOn Ultra -1/ HeezOn Ultra-2 on Male Sexual Health
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erectile Dysfunction
Premature Ejaculation
Lead sponsor: Vedic Lifesciences Pvt. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Enovate Biolife Pvt Ltd
First posted: 2016-06-09
Enrollment: 15
Sex: MALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Planning to have regular sexual activity (more than twice/ week).
2. Body Mass Index should be ≤ 29 kg/m2.
3. Subjects suffering from erectile dysfunction indicated by SHIMscore ≥ 12 and ≤ 16 for more than 3 months and less than 6 months.

   OR
4. Subjects suffering from predominantly from premature ejaculation as indicated by PEDT score more than 11 for more than 3 months and less than 6 months.
5. Fasting blood sugar ≤ 120 mg/dl.
6. The subjects have to be non-smoker and non-alcoholic.

Exclusion Criteria:

1. Subjects having SHIM score \<12 and \> 16.
2. Subjects suffering from premature ejaculation predominantly as indicated by PEDT score less than 11.
3. Subjects with major psychiatric disorders or severe systemic disorders
4. Subject having uncontrolled diabetes mellitus and hypertensive on active treatment
5. Subjects having history of male sexual dysfunction more than six months in diabetic subjects.
6. Anatomical deformity of the penis such as severe penile fibrosis or Peyronie's disease or phimosis.
7. Subjects detected with HIV and suffering from AIDS.
8. Has an abnormal thyroid stimulating hormone (TSH) level lower than 30% of lower limit normal or more than 30% of upper limit normal.
9. Has erectile dysfunction caused by neurological or endocrine factors such as hyper-prolactinemia.
10. Subjects with history of major systemic disorders.
11. Subject with history of drug abuse.
12. Subjects using medications known to cause sexual dysfunction (cimetidine, spironolactone, thiazides, adrenergic blockers, antidepressants etc.)
13. Subject has participated in any clinical trial within last 30 days.
14. Subjects not ready to sign the consent \& unable to comply the protocol.

Primary outcomes:
measure: Change in scores of Sexual Health Inventory for Men
timeFrame: Day 0, Day 1, Day 3, Day 14 and Day 28
Secondary outcomes:
measure: Sexual Hormone Binding Globulin
timeFrame: Day 0 and Day 14
measure: Free Testosterone
timeFrame: Day 0 and Day 14
measure: Change in scores of Sexual Quality of Life - Male
timeFrame: Day 0, Day 1, Day 3, Day 14 and Day 28
Other outcomes:
Locations:
Study officials:
affiliation: Maharashtra Medical Council
name: Sandip Patil, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Maharashtra Council of Homoeopathy Mumbai
name: Shirish Malde, BHMS
role: PRINCIPAL_INVESTIGATOR
References: