Health Condition 1: N528- Other male erectile dysfunction
Conditions
Interventions
Intervention1: NRL/MW/201901: Subjects will be advised to
consume NRL/MW/201901 one
Capsule twice daily orally after meal with lukewarm
water for 2 months.
Control Intervention1: Placebo: Alike placeb
Sponsors
Netsurf Communications Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Male subjects aged 21-50 years suffering from ED. Subjects who have scored 11 to 25 on the Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) at screening visit. Subjects should be in an active stable sexual relationship for the entire duration of study Subjects willing to participate in clinical trial and who have read understood and signed informed consent form. Subjects willing to make all required study visits
Exclusion criteria
Exclusion criteria: Subjects having anatomical abnormalities of the penis. Patients that have undergone radical prostatectomy, spinal cord injury, or any other surgery of urogenital organs. Subjects with severe form of sexual dysfunction as evidenced by at least one of the following conditions, - An International Index of Erectile Function-Erectile Function (IIEF-EF) domain score that is less than 11 and greater than 25 at screening - Subjects with prior ineffective treatment with (or non-responder to) any PDE5 Inhibitor or underwent treatment for promoting spermatogenic fertility in last 3 months - Subjects with ED caused by other primary disorders or ED caused by untreated/inadequately treated endocrine disease - History of radical prostatectomy or other pelvic surgery or penile implant, or a clinically significant penile deformity, in the opinion of the investigator - Presence of any drug or therapy that may have relation with ED and sexual dysfunction (nitrates, anti-androgens, chemotherapy agents, radiotherapy, etc.) Subjects with history or presence of significant alcoholism or drug abuse within the past 1 year. Presence or history of any of the following disorders/disease within the past 3 months, that might have impact on the clinical trial as per the investigator discretion- a. cardiovascular, b) cerebrovascular, c) dermatological, d) gastrointestinal, e) gynecological, f) hematological, g) hepatic, h) malignancy, i) metabolic, j) musculoskeletal, k) neurological, l) psychiatric, m) thyroid n) psychological, o) renal, p) respiratory, q) venereal, r) any other major disorders Subjects with history or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco/nicotine products more than 10 times per day. Subjects with any clinically significant laboratory or ECG findings during screening. Patients receiving hormonal treatment, antidepressants, antipsychotics, or any other psychoactive drugs. Known cases of varicocele, hydrocele, HIV/AIDS, Hepatitis C and B, Cancer and major debilitating diseases as a clinical observation. Known hypersensitivity to ingredients used in study drugs Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his participation in, and completion of the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sexual health parameters of IIEF Questionnaire Quality of penile erection on Quality of Erection Questionnaire (QEQ) Serum total testosterone Male sexual health on Erectile Dysfunction Inventory of Treatment Satisfaction EDITS questionnaire Patient and Partner version Sexual encounter profile as per the recordings in daily diary card with Intra-vaginal ejaculation latency time IELT as per the recordings in daily diary card.Timepoint: Apart from serum testosterone all other parameters will be assessed on baseline, 30 days and 60 days. Serum testosterone will be analysed on baseline and day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate changes in anthropometric parameters To assess change in Subjective Vitality Score,Perceived Stress Scale,satisfaction with life score Drug compliance Global assessment for overall improvement by the investigator and by patient Tolerability of study drugs Vitals (radial pulse, blood pressure, respiratory rate, and axial temperature) Adverse events Laboratory parameters to assess safetyTimepoint: All parameters will be assessed at baseline and end of study ie 60 days | — |
Countries
India
Contacts
Public ContactDr Omkar Kulkarni
Netsurf Research Labs Pvt Ltd
Outcome results
None listed