| CTRI Number |
CTRI/2024/05/067557 [Registered on: 17/05/2024] Trial Registered Prospectively |
| Last Modified On: |
16/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Efficacy, Safety, and Tolerability of Argin ED in the Treatment of Erectile Dysfunction in Elderly Diabetic Patients |
|
Scientific Title of Study
|
An Open Label, Prospective, Randomized, Three Arm Parallel Study to Compare the Clinical Efficacy, Safety, and Tolerability of L Arginine plus Fenugreek, Tadalafil plus L Arginine Plus Fenugreek, and Tadalafil plus Testosterone in the Treatment of Erectile Dysfunction in Elderly Diabetic Patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MC/ARG/23-008, Version 1.0 dated 22 Aug 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nagashankar N |
| Designation |
Senior Marketing Manager |
| Affiliation |
Fourrts (India) Laboratories Pvt. Ltd. |
| Address |
Plot No-1, Fourrts Avenue, Annai Indira Nagar, Okkiyam Thoraipakkam, Chennai-600097
Chennai
TAMIL NADU
600097
India |
| Phone |
9884450603 |
| Fax |
|
| Email |
nagashankar.n@fourrts.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nagashankar N |
| Designation |
Senior Marketing Manager |
| Affiliation |
Fourrts (India) Laboratories Pvt. Ltd. |
| Address |
Plot No-1, Fourrts Avenue, Annai Indira Nagar, Okkiyam Thoraipakkam, Chennai-600097
TAMIL NADU
600097
India |
| Phone |
9884450603 |
| Fax |
|
| Email |
nagashankar.n@fourrts.com |
|
Details of Contact Person
Public Query
|
| Name |
Nagashankar N |
| Designation |
Senior Marketing Manager |
| Affiliation |
Fourrts (India) Laboratories Pvt. Ltd. |
| Address |
Plot No-1, Fourrts Avenue, Annai Indira Nagar, Okkiyam Thoraipakkam, Chennai-600097
TAMIL NADU
600097
India |
| Phone |
9884450603 |
| Fax |
|
| Email |
nagashankar.n@fourrts.com |
|
|
Source of Monetary or Material Support
|
| Fourrts (India) Laboratories Pvt. Ltd. Plot No-1, Fourrts Avenue, Annai Indira Nagar, OkkiyamThoraipakkam, Chennai-600097 |
|
|
Primary Sponsor
|
| Name |
Fourrts (India) Laboratories Pvt. Ltd. |
| Address |
Fourrts (India) Laboratories Pvt. Ltd. Plot No-1, Fourrts Avenue, Annai Indira Nagar, OkkiyamThoraipakkam, Chennai-600097 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Deepak Jumani |
My Best Doctor Clinic Sexual health and Complete Wellness Clinic |
My Best Doctor Clinic Sexual health and Complete Wellness Clinic, Aum Heights Rohini Chs, Ground floor, 10, GrFl, off New Link Road, Shastri Nagar, Goregaon West, Mumbai, Maharashtra 400104
Mumbai
MAHARASHTRA |
9821044556
deepak.jumani@gmail.com |
| Dr Rupesh Kumar |
Recare Hospitals, Hyderabad |
Recare Hospitals, Hyderabad, Susrutha Medical Towers, 3rd Floor, door no. 16/2-701 main road, Malakpet, Chaitanyapuri Colony, Hyderabad
Hyderabad
TELANGANA |
9581142778
rupesh.fmt345@gmail.com |
| Dr Sanjay Deshpande |
Sex Education and Counseling Clinic |
Sex Education and Counseling Clinic, Third Floor, Meherprasad Complex, Central Bazar Road, Ramdaspeth, Nagpur- 440010
Nagpur
MAHARASHTRA |
9922941483
sanjaygdeshpande2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| S2J Independent Ethics Committee |
Submittted/Under Review |
| Virtuous Institutional Medical Research EC |
Submittted/Under Review |
| ZanEthics institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N521||Erectile dysfunction due to diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Argin ED (L-Arginine 800mg + Fenugreek 200mg) for 12 weeks |
Patients will be treated with 3 tablets of Argin ED (L-Arginine
800mg + Fenugreek 200mg) once daily after dinner for 12 weeks |
| Comparator Agent |
Tadalafil 5mg + Argin ED (L-Arginine 800mg + Fenugreek
200mg) for 12 weeks |
Patients will be treated with 1 tablet of Tadalafil 5mg and 3 tablets of Argin ED (L-Arginine 800mg + Fenugreek 200mg) once daily after dinner for 12 weeks |
| Comparator Agent |
Tadalafil 5mg + Testosterone gel for 12 weeks |
Patients will be treated with Tadalafil 5mg + Testosterone gel
once daily after dinner for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
1. Male aged ≥50 years
2. Controlled type 2 diabetes mellitus (based on Investigator’s judgement)
3. ED for at least 3 months prior to enrollment (ED defined as ‘a history of persistent inability to achieve or maintain an erection sufficient for satisfactory sexual performance’)
4. Total IIEF-5 score less than 22 at enrollment
5. In a stable and active monogamous heterosexual relationship for at least 6 months prior to enrollment
6. Willingness to provide written informed consent |
|
| ExclusionCriteria |
| Details |
1. Uncontrolled type 2 diabetes mellitus (HbA1C greater than 9%)
2. Known diagnosis of a sexual disorder other than ED
3. Regular smoking [at least one cigarette (or equivalent) per day]
4. Alcohol abuse [less than 4 drinks on any day or greater than 14 drinks per week]
5. Drug abuse (excessive, maladaptive, or addictive use of drugs for nonmedical purposes, as judged by the Investigator)
6. Clinically significant hypertension, hypotension, major hematological disease, renal disease, hepatic diseases, macroalbuminuria, chronic prostatitis, neurological diseases,
coronary heart disease, peripheral or
cerebrovascular disease, endocrine diseases, hypogonadism, hyperprolactinemia, history of pelvic trauma or surgery, or major psychiatric disorders
7. Clinically significant penile deformities (or with penile implants), total erectile failure, testes hypotrophy, fibrotic anomalies in the penis, phimosis, Peyronie s disease, or history
of surgical procedures associated with penis
8. Clinically significant proliferative diabetic retinopathy
9. Clinically significant sexually transmitted diseases, carcinoma, acquired immunodeficiency syndrome, tuberculosis, congenital abnormalities of genital organs, peptic ulcer, hydrocele, or spinal cord lesions
10. Stroke or myocardial infarction within 6 months prior to enrollment
11. History of ketoacidosis within 3 years prior to enrollment
12. Pharmacotherapy for ED with any of the study medications within 30 days prior to enrollment
13. Pharmacotherapy for ED with any drug other than study medications within 6 months prior to enrollment
14. Known allergy, hypersensitivity, proven inefficiency, or contraindications to any of the study medications or products containing any of the study medications
15. Chronic intake of central nervous system or antiandrogen drugs
16. Ongoing treatment with or requirement of any medications during trial participation that may contain any of the following: nitrates, estrogens, antiandrogens, anxiolytic drugs, LH-RH analogs, or tricyclic antidepressants
17. Participation in another clinical trial within past 30 days
18. Refusal or inability to comply with the requirements of the protocol for any reason, including scheduled clinic visits and laboratory tests
19. Any other condition(s) which would make the patient, in the opinion of the Investigator, unsuitable for the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in total IIEF-5 score from baseline to 12 weeks |
Day 0 & weeks 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Change in free serum testosterone level (in nmol/L) from baseline (prior to medication administration) to 12 weeks (48 hrs after the last dose of medication) |
Day 0, Week 12 |
| Change in total serum testosterone level (in nmol/L) from baseline (prior to medication administration) to 12 weeks (48 hrs after the last dose of medication) |
Day 0, Week 12 |
| Change in total IIEF-5 score from baseline to 4 and 8 weeks |
Day 0, Week 4 & Week 8 |
| Proportion of subjects with severe (IIEF-5 score 5–7), moderate (IIEF-5 score 8–11), mildto- moderate (IIEF-5 score 12–16), and mild (IIEF-5 score 17–21) ED at baseline and at week 12 |
Day 0, Week 12 |
| Changes in fasting blood sugar and HbA1C from baseline to 12 weeks |
Day 0 & weeks 12 |
| Proportion of subjects with adverse events and serious adverse events |
Day 0, Week 4, Week 8 & Week 12 |
| Subject-rated improvement (worsened, no change, or improved) at the end of 12 weeks of treatment |
Week 12 |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
03/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This study aims to compare the Clinical Efficacy, Safety, and Tolerability of L-Arginine + Fenugreek, Tadalafil + L-Arginine + Fenugreek, and Tadalafil + Testosterone in the Treatment of Erectile Dysfunction in Elderly Diabetic Patients. The primary objective is to compare the clinical efficacy of L-Arginine + Fenugreek, Tadalafil + L-Arginine + Fenugreek, and Tadalafil + Testosterone in improvement of IIEF-5 score in elderly diabetic patients with erectile dysfunction. The secondary objective is to compare the safety and tolerability of L-Arginine + Fenugreek, Tadalafil + L-Arginine + Fenugreek, and Tadalafil + Testosterone in elderly diabetic patients with erectile dysfunction. The study is designed as a prospective, Interventional, Randomized, Open-label, Parallel Group, Comparative, Multicentric. The study population consist of patients in the age group of ≥50 years diagnosed with elderly diabetic patients with erectile dysfunction. The study visit will be as per the following schedule: Visit 1 (Day 0): Screening, Randomization, Enrollment, Baseline assessment, and Treatment initiation Visit 2 [Day 28 (4 weeks) ± 7 days]: Follow-up visit Visit 3 [Day 56 (8 weeks) ± 7 days]: Follow-up visit Visit 4 [Day 84 (12 weeks) ± 7 days]: 48 hrs after end of treatment; End-of-study visit Unscheduled visit: As required (during study participation) |