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

Primary Purpose

Erectile Dysfunction, Premature Ejaculation

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

HeezOn Ultra-1

HeezOn Ultra-2

Placebo

About this trial

This is an interventional treatment trial for Erectile Dysfunction

Eligibility Criteria

30 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

HeezOn Ultra-1

HeezOn Ultra-2

Placebo

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

Change in scores of Sexual Health Inventory for Men

Secondary Outcome Measures

Sexual Hormone Binding Globulin

Free Testosterone

Change in scores of Sexual Quality of Life - Male

Full Information

NCT ID

NCT02794454

First Posted

May 31, 2016

Last Updated

January 27, 2017

Sponsor

Vedic Lifesciences Pvt. Ltd.

Collaborators

Enovate Biolife Pvt Ltd

1. Study Identification

Unique Protocol Identification Number

NCT02794454

Brief Title

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

Acronym

HeezOn-Ultra

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

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Completed

Study Start Date

May 2016 (undefined)

Primary Completion Date

January 2017 (Actual)

Study Completion Date

January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vedic Lifesciences Pvt. Ltd.

Collaborators

Enovate Biolife Pvt Ltd

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Erectile Dysfunction, Premature Ejaculation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HeezOn Ultra-1

Arm Type

Active Comparator

Arm Description

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.

Arm Title

HeezOn Ultra-2

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

HeezOn Ultra-1

Intervention Type

Other

Intervention Name(s)

HeezOn Ultra-2

Intervention Type

Other

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Change in scores of Sexual Health Inventory for Men

Time Frame

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

Secondary Outcome Measure Information:

Title

Sexual Hormone Binding Globulin

Time Frame

Day 0 and Day 14

Title

Free Testosterone

Time Frame

Day 0 and Day 14

Title

Change in scores of Sexual Quality of Life - Male

Time Frame

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

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sandip Patil, M.D.

Organizational Affiliation

Maharashtra Medical Council

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Shirish Malde, BHMS

Organizational Affiliation

Maharashtra Council of Homoeopathy Mumbai

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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