| CTRI Number |
CTRI/2024/01/061831 [Registered on: 25/01/2024] Trial Registered Prospectively |
| Last Modified On: |
24/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical study of ELED01 (supplement for general wellbeing) in healthy individuals |
|
Scientific Title of Study
|
Evaluation of efficacy and safety of EL ED 01 in healthy individuals A Randomized, Double Blind, Placebo Controlled, Multi centric, Interventional, Prospective, Clinical Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| EMIL/ED/HLTHY/2023, Version 1.0, 02nd September 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shailesh V Deshpande |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurveda and Hospital, Parul university |
| Address |
Dept. of Kayachikitsa, OPD No. 108, Ground Floor
Parul Institute of Ayurveda and Hospital, Parul university, Post. Ishwarpura - Limda, Taluka. Waghodia, Dist. Vadodara, Gujrat
Vadodara
GUJARAT
391760
India |
| Phone |
9763104451 |
| Fax |
|
| Email |
dr.shaileshd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd. |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd.
A wing 402 A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400064
India |
| Phone |
09322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd. |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd.
A wing 402 A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai
MAHARASHTRA
400064
India |
| Phone |
09322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Emil Pharmaceutical Industries Private Limited,
301, Western Edge 1, Above Metro Mall, Magathane, Western Express Highway, Kulupwadi, Borivali East, Mumbai, Maharashtra 400066 India.
|
|
|
Primary Sponsor
|
| Name |
Emil Pharmaceutical Industries Private Limited |
| Address |
301, Western Edge 1, Above Metro Mall, Magathane, Western Express Highway, Kulupwadi, Borivali East, Mumbai, Maharashtra 400066 India.
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shailesh V Deshpande |
Parul Institute of Ayurveda and Hospital |
Dept. of Kayachikitsa, OPD No. 108, Ground Floor
Parul university, Post. Ishwarpura - Limda, Taluka. Waghodia, Dist. Vadodara, 391760 Gujrat
Vadodara
GUJARAT |
09763104451
dr.shaileshd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) Parul Institute of Ayurved Parul University, |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
EL ED 01 Tabet
|
Dosage and treatment duration:
1 Tablet twice daily orally after meals with water for 30 days
|
| Comparator Agent |
Placebo Tablet |
Dosage and treatment duration:
1 Tablet twice daily orally after meals with water for 30 days
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in erectile function of penis on Erectile function subscale of IIEF Questionnaire
2. Change in hardness of penis
|
Day 0, Day 15 and Day 30
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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
|
Day 0, Day 15 and Day 30
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "61"
Final Enrollment numbers achieved (India)="61" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
29/01/2024 |
| Date of Study Completion (India) |
06/07/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
It is a randomized, double blind, placebo controlled, multi-centric, interventional, prospective, clinical study to evaluate efficacy and safety of EL/ED/01 in healthy individuals. As per computer generated randomization list subjects will be asked to take given product in a dose of 1 Tablet twice daily orally after meals with water for 30 days. The study will be carried out at 3 to 4 centers in India. The primary objectives of the study will be to assess change in erectile function of penis on Erectile function subscale of IIEF Questionnaire and change in hardness of penis. The secondary objectives of the study will be to assess change in sexual desire, libido and other parameters of IIEF questionnaire, change in male sexual health on EDITS questionnaire, change in quality of penile erection on Quality of Erection Questionnaire, change in quality of Sexual life on Sexual Quality of Life Questionnaire, change in sexual encounter profile as per the recordings, change in premature ejaculation using Premature Ejaculation Profile, change in energy, strength and stamina, global assessment for overall change by investigator and by subjects, tolerability of study products and adverse events, Adverse reactions, and vitals on Day 0, Day 15 and Day 30
Summary of Results:
The study concludes that the use of EL/ED/01 tablets helped to significantly improve
erection function, orgasimic satisfaction and intercourse satisfaction over a
period of 30 days. There was a significant improvement in penile hardness and
premature ejaculation also reduced significant over a period of 30 days use of
EL/ED/01 tablets. Quality of sexual life showed significant improvement as
reported by the participant as well as the partner. EL/ED/01 tablets
consumption was found to be safe without causing any adverse effects. |