Erectile DysfunctionHeezOn-UltraNCT02794454
A Study to Evaluate Efficacy of Investigational Product HeezOn Ultra -1/ HeezOn Ultra-2 on Male Sexual Health
A study testing HeezOn Ultra-1 and HeezOn Ultra-2 in people with Erectile Dysfunction and Premature Ejaculation, run by Vedic Lifesciences Pvt. Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years, men only
- Conditions the study is for
- Erectile Dysfunction, Premature Ejaculation
- What is being tested?
- HeezOn Ultra-1 and HeezOn Ultra-2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
- OR
- 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.
Who cannot join
- 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.
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- 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.
About this study
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
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.
- Conditions
- Erectile Dysfunction, Premature Ejaculation
- Being tested
- HeezOn Ultra-1, HeezOn Ultra-2, Placebo
- Medical subject headings
- Erectile Dysfunction, Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeezOn Ultra-1Other
HeezOn Ultra-2Other
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in scores of Sexual Health Inventory for Men
Measured: Day 0, Day 1, Day 3, Day 14 and Day 28
Secondary outcomes (3)
Sexual Hormone Binding Globulin
Measured: Day 0 and Day 14
Free Testosterone
Measured: Day 0 and Day 14
Change in scores of Sexual Quality of Life - Male
Measured: Day 0, Day 1, Day 3, Day 14 and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Enovate Biolife Pvt Ltd
- Responsible party
- Sponsor
- Investigators
- Sandip Patil, M.D., Principal investigator, Maharashtra Medical CouncilShirish Malde, BHMS, Principal investigator, Maharashtra Council of Homoeopathy Mumbai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02794454
- Sponsor's protocol ID
- EB/151005/HZ-U/SD
- Acronym
- HeezOn-Ultra
- Status last verified
- Jun 2016
- First submitted
- 31 May 2016
- Last updated
- 30 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02794454
- Acronym / sponsor ID
- HeezOn-Ultra / EB/151005/HZ-U/SD
- Conditions
- Erectile Dysfunction, Premature Ejaculation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Enovate Biolife Pvt Ltd
- Study start
- May 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 9 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HeezOn Ultra-1 | Active comparator | Other: HeezOn Ultra-1HeezOn Ultra-1 includes ingredients like Shilajit, Galangal, Fenugreek. Dose: 2 capsules daily half an hour before dinner to be taken orally for 21 days. |
| HeezOn Ultra-2 | Active comparator | Other: HeezOn Ultra-2HeezOn Ultra-2 includes ingredients like Arjuna, Galangal, Fenugreek. Dose: 2 capsules daily half an hour before dinner to be taken orally for 21 days. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo consists of Micro-crystalline Cellulose. Dose: 2 capsules daily half an hour before dinner to be taken orally for 21 days. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
- OR
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HeezOn Ultra-1 | Other | HeezOn Ultra-1 |
| HeezOn Ultra-2 | Other | HeezOn Ultra-2 |
| Placebo | Other | Placebo |
Primary outcome
Change in scores of Sexual Health Inventory for Men
Time frame: Day 0, Day 1, Day 3, Day 14 and Day 28
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandip Patil, M.D. principal investigator
Maharashtra Medical Council
Shirish Malde, BHMS principal investigator
Maharashtra Council of Homoeopathy Mumbai
Questions about this trial
What is this clinical trial studying?
A study testing HeezOn Ultra-1 and HeezOn Ultra-2 in people with Erectile Dysfunction and Premature Ejaculation, run by Vedic Lifesciences Pvt. Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in scores of Sexual Health Inventory for Men (time frame: Day 0, Day 1, Day 3, Day 14 and Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2017.