Health Condition 1: N529- Male erectile dysfunction, unspecified
Conditions
Interventions
Intervention1: EL/ED/01 Tablet: Subjects will be asked to consume given product in a dose of 1 tablet twice daily orally after meals with water for 30 days.
Control Intervention1: Placebo Tablet: Subj
Sponsors
Emil Pharmaceutical Industries Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy Subjects who have scored 22 to 25 on the Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) at screening. 2. Subjects who are ready to provide written informed consent and who are ready to willingly participate and follow the protocol requirements of the clinical study
Exclusion criteria
Exclusion criteria: 1. Subjects with known major illnesses and sexual dysfunction due to anatomical, surgical, or pharmacological causes 2. History of radical prostatectomy or other pelvic surgery or penile implant, or a clinically significant penile deformity, in the opinion of the investigator. 3. Presence of any drug or therapy that may have relation with ED and sexual dysfunction 4. Subjects with total erectile failure 5. Subjects with known hypogonadism or anatomical deformity of the penis such as severe penile fibrosis or Peyronie disease or penile trauma 6. Subjects with history of disorders that may cause priapism 7. Subjects who are taking any medication for psychiatric disorder 8. Subjects with history of central nervous system disorders such as stroke, transient ischemic attacks or spinal cord injury or pelvic surgery 9. Subjects with hypotension or hypertension, diabetes, hepatic impairment, renal impairment or hematological disorders 10. Subjects with significant abnormal laboratory parameters 11. Known cases of varicocele, hydrocele, HIV, AIDS, Hepatitis C and B, Cancer and major debilitating diseases 12. Subject having known hypersensitivity to any ingredient of the study products.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in Erectile function of penis on Erectile function subscale of IIEF Questionnaire 2. Change in Hardness of penis assessed on Erection Hardness Score (EHS) Timepoint: Day 0, Day 15 and Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in Sexual desire/ libido and other parameters of IIEF questionnaire 2. Change in male sexual health on EDITS questionnaire (Participant & Partner version) 3. Change in quality of penile erection on Quality of Erection Questionnaire (QEQ) 4. Change in quality of Sexual life on Sexual Quality of Life Questionnaire (SQoL-M) 5. Changes in serum total free testosterone level 6. Sexual encounter profile 7. Change in premature ejaculation as assessed using Premature Ejaculation Profile (PEP) 8. Global assessment for overall change by investigator and by subjects 9.Tolerability of study products 10. Adverse events/ Adverse reactions and vitals 11. Changes in Laboratory parametersTimepoint: Day 0, Day 15 and Day 30 | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research Pvt. Ltd.
Outcome results
None listed