efficacy study of himcolin gel in erectile dysfunctio
- Conditions
- Health Condition 1: N529- Male erectile dysfunction, unspecified
- Registration Number
- CTRI/2019/07/020017
- Lead Sponsor
- The Himalaya Drug Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Improvement in the International Index of Erectile Function - (IIEF-5) Domain Score in two variants, change from Day 1 to Day 14 (week 1 & 2)and from Day 22 to Day 35 (week 4 & 5) <br/ ><br>2. Comparison of IIEF-5 scoring at the end of the study between two variants.Timepoint: Subjects will receive variant-I for Week-1 & 2. Week-3 is wash out period and will receive Variant-II for Week 4 & 5
- Secondary Outcome Measures
Name Time Method 1. Improvement in the International Index of Erectile Function - (IIEF-5) Domain Score in two variants, change from Day 1 to Day 14 (week 1 & 2)and from Day 22 to Day 35 (week 4 & 5) <br/ ><br>2. Comparison of IIEF-5 scoring at the end of the study between two variants. <br/ ><br>Timepoint: Subjects will receive variant-I for Week-1 & 2. Week-3 is wash out period and will receive Variant-II for Week 4 & 5