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CompletedNCT02794454HeezOn-UltraUpdated Jan 30, 2017

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

An interventional study of HeezOn Ultra-1 and HeezOn Ultra-2 in Erectile Dysfunction and Premature Ejaculation, sponsored by Vedic Lifesciences Pvt. Ltd.. Completed. Open to male participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-01-30.

Sponsored by Vedic Lifesciences Pvt. Ltd. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
30 Years to 60 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Erectile Dysfunction
  • Premature Ejaculation
03

In context

Erectile Dysfunction

683 studies on the registry are indexed under Erectile Dysfunction; 117 are open to participants now.

This study's enrollment of 15 is below the median of 72 across 542 interventional studies indexed under Erectile Dysfunction.

Browse Erectile Dysfunction studies →

Lead sponsor

Vedic Lifesciences Pvt. Ltd. is the lead sponsor of 71 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
15 participants (actual)

Study arms

  • 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

Interventions

  • OtherHeezOn Ultra-1
  • OtherHeezOn Ultra-2
  • OtherPlacebo
06

What researchers measure

Primary outcomes

  1. Change in scores of Sexual Health Inventory for Men

    Time frame: Day 0, Day 1, Day 3, Day 14 and Day 28

Secondary outcomes

  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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02794454
Lead sponsor
Vedic Lifesciences Pvt. Ltd.
Collaborators
Enovate Biolife Pvt Ltd
Responsible party
Sponsor
First posted
Jun 9, 2016
Start date
May 2016
Primary completion
Jan 2017
Completion
Jan 2017
Last update
Jan 30, 2017

Study contacts

Sandip Patil, M.D.
principal investigator · Maharashtra Medical Council
Shirish Malde, BHMS
principal investigator · Maharashtra Council of Homoeopathy Mumbai

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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