Clinical assessment of efficacy and safety of NRL/MW/201901 in patients suffering from erectile dysfunction- A Randomized, Double Blind, Placebo Controlled, Interventional, Prospective, Clinical Study.

After Ethics committee’s approval, clinical study will be registered on CTRI website. Married male subjects of age between 21 to 50 years of age (both inclusive) attending outpatient department of study site(s) will be screened for eligibility criteria. On screening visit, a written informed consent will be obtained from subjects for their participation in the study.  Subject’s demographic details will be taken. Subject will undergo clinical examination (general and systemic examination including CVS, RS, gastrointestinal, genitourinary and CNS). Subject’s medical, surgical and treatment history will be taken. Subject’s current medication if any will be noted in the case record from (CRF). Subject’s vitals (radial pulse, blood pressure, respiratory rate, and axial temperature) will be recorded.

Subject’s examination for sexual dysfunction will be done including assessment of any organic cause of Sexual Dysfunction. Assessment of Erectile function will be done using Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF) questionnaire. If subject’s EF Domain score is 11 to 25 and subject should be in an active stable sexual relationship for the entire duration of study then subject will be considered for further evaluation as per the inclusion and exclusion criteria.

Subject will be called next day morning on empty stomach for laboratory testing. Subject’s blood sample will be collected at the respective study centers for laboratory testing i.e. serum total testosterone, CBC, ESR, Hb%, RBS-F, Liver Function Tests, Lipid Profile, Renal Profile, Urine Routine and Microscopic and ECG will be done. During screening visit and the entire study duration subjects will be advised to refrain from antioxidant agents, vitamins, anti-inflammatory drugs, hormones, Nutraceutical, Ayurvedic, Siddha, Unani, herbal /homeopathic medicines for the treatment of erectile dysfunction. A screening window of 14 days will be kept, in case if there is delay in availability of tests reports or in case few tests need to be repeated. Subject will be called for baseline visit assessment (day 0).

On baseline visit, subject will be recruited in the study if he meets all the inclusion criteria. Subjects will then be randomized to one of the two study groups as per the computer generated randomization list. Subjects will be asked for occurrence of any adverse event during screening period. Subject will undergo clinical examination (general and systemic examination including CVS, RS, gastrointestinal, genitourinary and CNS). Subject’s vitals (radial pulse, blood pressure, respiratory rate, and axial temperature) will be recorded. Subject’s erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall satisfaction will be assessed on International Index of Erectile Function (IIEF). Subject’s quality of penile erection will be evaluated on quality of erection questionnaire (QEO). Daily diary card will be issued to subject to maintain the record of sexual encounter profile and intra-vaginal ejaculation latency time (IELT). Subject will be assessed for anthropometric parameters, Subjective Vitality Score, Perceived Stress Scale Satisfaction with life score.

At baseline visit and at every follow up visit (except last follow up visit), as per computer generated randomization list, subjects will be provided test capsules doses for 30 days + additional capsules for use if follow up is delayed maximum up to 5 days) of either test or matching placebo. Subject will be advised to consume medication in a dose of 1 capsule twice daily orally after meals with water for 2 months. Subject will be advised to continue his concomitant medication other than antioxidant agents, vitamins, anti-inflammatory drugs, hormones, Nutraceutical, Ayurvedic, Siddha, Unani, herbal /homeopathic medicines etc. The record of concomitant medication will be kept in the CRF. Drug compliance will be assessed by the investigator on every follow up visit. Subjects who continuously misses dosing for >3 consecutive days or total missed dose > 9 days during the study period will be treated as drop outs. Subjects will be allowed to come for follow up either 5 days prior or after the scheduled follow up visit, provided subject should continue the given treatment.  Subjects will be advised to continue the diet and exercise regimen (which they are already following) during the entire study period.

Subjects will be called at respective study sites for follow up visits after every month up to 2 months after the baseline visit. On follow up visit, Subject will undergo clinical examination (general and systemic examination including CVS, RS, gastrointestinal, genitourinary and CNS). Subject’s vitals (radial pulse, blood pressure, respiratory rate, and axial temperature) will be recorded. Subject’s erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall satisfaction will be assessed on International Index of Erectile Function (IIEF). Subject’s quality of penile erection will be evaluated on quality of erection questionnaire (QEQ). Subject’s sexual health will be evaluated on Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire (patient version). Also subject’s partner will be evaluated on Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire. Average (from the daily diary) of the sexual encounters and intra-vaginal ejaculation latency time (IELT) will be recorded in the CRF.

Global assessment of overall improvement will be done by subject and investigator on last follow up visit. Tolerability of the trial drugs will be assessed by the investigator and by subject at the end of the trial. All the subjects will be closely monitored for any adverse event starting from baseline visit till the end of the study visit.

On final follow up visit (i.e. Day 60) subject’s serum total testosterone level will be checked. Subject’s CBC, ESR, Hb%, Liver Function Tests, Lipid Profile, Renal Profile, BSL-F, Urine Routine and Microscopic will be done. Subject will be assessed for anthropometric parameters, Subjective Vitality Score, Perceived Stress Scale Satisfaction with life score.

 After completion of 2 months of study treatment, all the subjects will be asked to stop trial medications and take advice of investigator for further treatment.