None listed
Conditions
Interventions
Intervention1: EL ED 01 Tabet
: Dosage and treatment duration:
1 Tablet twice daily orally after meals with water for 30 days
Control Intervention1: Placebo Tablet: Dosage and treatment duration:
1 T
Sponsors
Emil Pharmaceutical Industries Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Healthy participants 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: 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 (nitrates, anti-androgens, chemotherapy agents, radiotherapy, etc.) 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 who are using and or dependency or failure to keep abstinence for antioxidant agents, vitamins, anti-inflammatory drugs, hormones, Ayurvedic, herbal, homeopathic, naturopathy medications for erectile dysfunction 11. Subjects with preexisting systemic disease necessitating long-term medications, genetic and endocrinal disorders 12. Continuing history of alcohol and or drug abuse 13. Subjects with history of uncontrolled arrhythmia, acute ischemia and known active pulmonary tuberculosis 14. Subjects with significant abnormal laboratory parameters 15. Known cases of varicocele, hydrocele, HIV, AIDS, Hepatitis C and B, Cancer and major debilitating diseases 16. 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 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 3. Change in quality of penile erection on Quality of Erection Questionnaire 4. Change in quality of Sexual life on Sexual Quality of Life Questionnaire 6. Change in sexual encounter profile as per the recordings 7. Change in premature ejaculation using Premature Ejaculation Profile 8. Change in energy, strength and stamina 9. Global assessment for overall change by investigator and by subjects 10. Tolerability of study products 11. Adverse events, Adverse reactions, and vitals Timepoint: 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