Clinical study of ELED01 (supplement for general wellbeing) in healthy individuals

Phase 2

• Registration Number: CTRI/2024/01/061831
• Lead Sponsor: Emil Pharmaceutical Industries Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Change in erectile function of penis on Erectile function subscale of IIEF Questionnaire <br/ ><br>2.Change in hardness of penis <br/ ><br>Timepoint: Day 0, Day 15 and Day 30 <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1. Change in sexual desire, libido and other parameters of IIEF questionnaire <br/ ><br>2. Change in male sexual health on EDITS questionnaire <br/ ><br>3. Change in quality of penile erection on Quality of Erection Questionnaire <br/ ><br>4. Change in quality of Sexual life on Sexual Quality of Life Questionnaire <br/ ><br>6. Change in sexual encounter profile as per the recordings <br/ ><br>7. Change in premature ejaculation using Premature Ejaculation Profile <br/ ><br>8. Change in energy, strength and stamina <br/ ><br>9. Global assessment for overall change by investigator and by subjects <br/ ><br>10. Tolerability of study products <br/ ><br>11. Adverse events, Adverse reactions, and vitals <br/ ><br>Timepoint: Day 0, Day 15 and Day 30 <br/ ><br>