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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02794454
Recruitment Status : Completed
First Posted : June 9, 2016
Last Update Posted : January 30, 2017
Sponsor:
Collaborator:
Enovate Biolife Pvt Ltd
Information provided by (Responsible Party):
Vedic Lifesciences Pvt. Ltd.

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.


Condition or disease Intervention/treatment Phase
Erectile Dysfunction Premature Ejaculation Other: HeezOn Ultra-1 Other: HeezOn Ultra-2 Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.
Other: Placebo



Primary Outcome Measures :
  1. Change in scores of Sexual Health Inventory for Men [ Time Frame: Day 0, Day 1, Day 3, Day 14 and Day 28 ]

Secondary Outcome Measures :
  1. Sexual Hormone Binding Globulin [ Time Frame: Day 0 and Day 14 ]
  2. Free Testosterone [ Time Frame: Day 0 and Day 14 ]
  3. Change in scores of Sexual Quality of Life - Male [ Time Frame: Day 0, Day 1, Day 3, Day 14 and Day 28 ]


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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02794454


Sponsors and Collaborators
Vedic Lifesciences Pvt. Ltd.
Enovate Biolife Pvt Ltd
Investigators
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Principal Investigator: Sandip Patil, M.D. Maharashtra Medical Council
Principal Investigator: Shirish Malde, BHMS Maharashtra Council of Homoeopathy Mumbai

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Responsible Party: Vedic Lifesciences Pvt. Ltd.
ClinicalTrials.gov Identifier: NCT02794454     History of Changes
Other Study ID Numbers: EB/151005/HZ-U/SD
First Posted: June 9, 2016    Key Record Dates
Last Update Posted: January 30, 2017
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Erectile Dysfunction
Premature Ejaculation
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders