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

NCT02794454 | Completed

• 1 other identifier: EB/151005/HZ-U/SD
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Erectile Dysfunction; Premature Ejaculation

Outcome Measures

Primary Outcomes (1)

• Change in scores of Sexual Health Inventory for Men

  Day 0, Day 1, Day 3, Day 14 and Day 28

Secondary Outcomes (3)

• Sexual Hormone Binding Globulin

  Day 0 and Day 14

• Free Testosterone

  Day 0 and Day 14

• Change in scores of Sexual Quality of Life - Male

  Day 0, Day 1, Day 3, Day 14 and Day 28

Study Arms (3)

HeezOn Ultra-1

ACTIVE COMPARATOR

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

HeezOn Ultra-2

ACTIVE COMPARATOR

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

PLACEBO COMPARATOR

Placebo consists of Micro-crystalline Cellulose. Dose: 2 capsules daily half an hour before dinner to be taken orally for 21 days.

Other: Placebo

Interventions

HeezOn Ultra-1 OTHER

HeezOn Ultra-1

HeezOn Ultra-2 OTHER

HeezOn Ultra-2

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Planning to have regular sexual activity (more than twice/ week).
• Body Mass Index should be ≤ 29 kg/m2.
• Subjects suffering from erectile dysfunction indicated by SHIMscore ≥ 12 and ≤ 16 for more than 3 months and less than 6 months.
• 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.
• Fasting blood sugar ≤ 120 mg/dl.
• The subjects have to be non-smoker and non-alcoholic.

You may not qualify if:

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

Sponsors & Collaborators

• Vedic Lifesciences Pvt. Ltd.: lead
• Enovate Biolife Pvt Ltd: collaborator

MeSH Terms

Conditions

Erectile Dysfunction; Premature Ejaculation

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Ejaculatory Dysfunction

Study Officials

• Sandip Patil, M.D.

  Maharashtra Medical Council

  PRINCIPAL INVESTIGATOR

• Shirish Malde, BHMS

  Maharashtra Council of Homoeopathy Mumbai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2016
• First Posted: June 9, 2016
• Study Start: May 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: January 30, 2017

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share