Health Condition 1: N529- Male erectile dysfunction, unspecified Health Condition 2: F524- Premature ejaculation Health Condition 3: R37- Sexual dysfunction, unspecified Health Condition 4: F529- Unspecified sexual dysfunction notdue to a substance or known physiological condition
Conditions
Interventions
Intervention1: Boostex Forte Capsules: Dose : 2 Capsules
Dosage : 2 BID for 30 Days
Route of Administration : Oral
Treatment Duration: 30 Days
Control Intervention1: Not applicable as it is a non- co
Sponsors
SG Phyto Pharma Private Limited
Aurous HealthCare Research and Development India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult males aged between 25 and 60 years (both ages inclusive) with known history or complaint of sexual dysfunction not limited to - Erectile Insufficiency - Premature Ejaculation - Ability to achieve and maintain erection - Psychic Functional Impotency - Decreased Libido - History of decreased/insufficient sperm count, motility and health. 2. Subjects who are in a monogamous, heterosexual relationship 3. Subjects with or without children. 4. Subjects who have scored a total of lesser than equal to on the International Index of Erectile Function Domain A at the time of screening 5. Subject or LAR who is willing to give informed consent for participation, able to comprehend and understand the responsibilities during treatment period and follow up period. 6. Subjects who are willing not to participate in any other clinical trial during participation in the current trial. 7. Subjects who are willing to give all forms of medications or therapies for sexual dysfunction â?? oral, topical etc for the duration of the clinical study.
Exclusion criteria
Exclusion criteria: 1. Subjects with known hypersensitivity to herbal investigational product or its constituents. 2. Subjects with current or chronic infection not limited to urinary tract infection, chronic renal infection. 3. Subjects on medications or herbal supplements for sexual dysfunction. 4. Subjects with hypogonadism or anatomical deformities of the penis such as severe penile fibrosis or Peyronie disease or phimosis. 5. Subjects who are currently on medications that are known to cause sexual dysfunction- cimetidine, spironolactone, thiazides, adrenergic blockers, anti- depressants etc 6. Subjects with immunucompromised state complications. 7. Subjects with uncontrolled diabetes, hypertension or congestive heart failure. 8. Any significant medical condition e.g., significant psychiatric or neurological disorders, active alcohol or drug abuse, etc. , any medical condition that is unstable or poorly controlled or other factor e.g., planned relocation that the Investigator felt would interfere with study evaluations and study participation. 9. Subjects who have participated in any clinical study within 3 months from the date of enrolment. 10. Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol. 11. Subjects, who in the opinion of the Investigator are not eligible for enrolment in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. International Index of Erectile Function (IIEF): Total Score of greater than equal to 60. 2. Index of Premature Ejaculation: Total Score of greater than equal to 35 3. Boostex Forte: Quality of Life Questionnaire: Total Score of greater than equal to 10 4. International Index of Erectile Function (IIEF) : Total Score of greater than equal to 60 5. Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS): Patient Version: Total Score of greater than equal to 35 Timepoint: 1. International Index of Erectile Function (IIEF): Day 1, Day 30. 2. Index of Premature Ejaculation: Day 1, Day 30. 3. Boostex Forte: Quality of Life Questionnaire: Day 1, Day 30. Telephonic Day 45, Day 60 4. International Index of Erectile Function (IIEF) : Telephonic Day 45, Day 60 5. Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS): Patient Version: Telephonic Day 45, Day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| NoneTimepoint: None | — |
Countries
India
Contacts
Public ContactDr VT Sriraam
Raam Clinic
Outcome results
None listed