A Randomized Open Label Two Arm Comparative and Cross Over Clinical Study to Evaluate the Efficacy and Safety of Himcolin Gel of two Variants in Erectile Dysfunction.

The Himalaya Drug Company0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Men aged more than 18 -60 years (both inclusive)
•2.clinically identified as suffering from erectile dysfunction namely inability to have or sustain an erection adequate for satisfactory sexual activity.
•3.Willing to give a written informed consent and follow the schedule.
•4.History of Erectile Dysfunction for atleast 4 weeks.
•5.ED with IIEF-5 score of >80 to <21
•6.Subjects willing to participate in the study and follow visit schedule, including response to the questions related with the sexual function information for both himself and his partner and information on sexual intercourse.
•7.Subject and his partner agreeing to attempt sexual intercourse atleast 2 times / week.

•1.Individuals with the history and investigational diagnosis of organic pathology for erectile dysfunction.
•2.Any injury or wound or any anatomical defect on penis and pelvic region.
•3.Pre-existing systemic disease necessitating long-term medications.
•4.Genetic and endocrinal disorders.
•5.Has participated in a similar clinical investigation in the past four weeks.
•6.Sensitive for skin allergies,
•7.Not willing to sign informed consent form.
•8.Patients with an active urinary tract infection (UTI) or Prostatitis.
•9.Known or suspected allergy, hypersensitivity, or intolerance to any ingredients of study product.
•10.With any uncontrolled illness or a history of any illness judged by the investigator that entering the trial may be detrimental to the patient.
•11.Current treatment with systemic corticosteroids.
•12.Use of alpha blockers or nitrates within 4 weeks prior to the screening visit.
•13.Use of PDE-5 inhibitor, or other treatments for erectile dysfunction within the last 4 weeks prior to the screening visit
•14.Sexual partner is a pregnant or lactating female or a female with childbearing potential not taking reliable contraceptive methods during study period.
•15.ED due to structural abnormality of the penis

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