Health Condition 1: N529- Male erectile dysfunction, unspecified
Conditions
Interventions
Intervention1: PR/HC/1718/002 capsules: 2 capsules twice a day after meal with water for 3 months
Control Intervention1: Placebo: 2 capsules twice a day after meal with water for 3 months
Sponsors
Aayush Healthcare
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male subjects aged 21-50 years suffering from ED. 2.Subjects who have scored 11 to 25 on the Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) at screening visit. 3.Subjects should be in an active stable sexual relationship for the entire duration of study 4.Subjects willing to participate in clinical trial and who have read understood and signed informed consent form. 5.Subjects willing to make all required study visits
Exclusion criteria
Exclusion criteria: 1.Subjects having anatomical abnormalities of the penis. 2.Patients that have undergone radical prostatectomy, spinal cord injury, or any other surgery of urogenital organs. 3.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.) 4.Subjects with history or presence of significant alcoholism or drug abuse within the past 1 year. 5.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 6.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. 7.Subjects with any clinically significant laboratory or ECG findings during screening. 8.Patients receiving hormonal treatment, antidepressants, antipsychotics, or any other psychoactive drugs. 9.Known cases of varicocele, hydrocele, HIV/AIDS, Hepatitis C and B, Cancer and major debilitating diseases 10.Known hypersensitivity to ingredients used in study drugs 11.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 |
|---|---|
| To evaluate efficacy of SHL 1046 in patients suffering from erectile dysfunction by assessing 1.Erectile function of penis on Erectile function subscale of IIEF Questionnaire 2.Sexual desire/ Libido (IIEF questionnaire) Timepoint: Baseline, Day 30, Day 60, Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Hardness of penis 2.Subjective Vitality Score, Perceived Stress Scale,satisfaction with life score 3.Erectile Dysfunction Inventory of Treatment Satisfaction questionnaire (Patient & Partner version) 4.Quality of Erection Questionnaire 5.Serum total testosterone 6.Sexual encounter profile as per the recordings in daily diary card, IELT 7.Drug compliance 8.Global assessment for overall improvement by the investigator and by patient at the end of the study treatment.Timepoint: Baseline, Day 30, Day 60, Day 90 | — |
Countries
India
Contacts
Public ContactPayal Gawali
Aayush Healthcare
Outcome results
None listed