Prostatic Hyperplasia Treatment and Cancer Prevention
Sponsor
Manchanda Medical Clinic (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT03064282
Collaborator
(none)
40
2
5.1
Study Details
Study Description
Brief Summary
Treatment of patients with prostatic hyperplasia with topical papaverine.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Detailed Description
Patients with obstructive voiding and high PSA to be studied for the regression of symptoms and declining PSA.
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
40 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Treatment of Prostatic Hyperplasia With Topical Papaverine
Anticipated Study Start Date
:
Jun 30, 2021
Anticipated Primary Completion Date
:
Sep 30, 2021
Anticipated Study Completion Date
:
Dec 1, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo Drug free base as placebo |
Other: Placebo
observation of skin changes if any
Other Names:
|
| Experimental: group two- papaverine arm papaverine in a suitable base |
Drug: papaverine
observation of symptoms
|
Outcome Measures
Primary Outcome Measures
- Laboratory tests to measure regression of symptoms [every 4 weeks up to 16 weeks]
patients follow-up on regular intervals
Eligibility Criteria
Criteria
Ages Eligible for Study:
50 Years
to 70 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- patients with symptoms e.g. obstructive voiding, hyperplasia and high PSA
Exclusion Criteria:
-
patients on chemotherapy
-
abnormal lab values e.g. liver function, GFR and CAD
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Manchanda Medical Clinic
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
Responsible Party:
DR. VINOD C TAWAR,
Principal Investigator,
Manchanda Medical Clinic
ClinicalTrials.gov Identifier:
NCT03064282
Other Study ID Numbers:
- Tawar - 2
First Posted:
Feb 27, 2017
Last Update Posted:
Feb 25, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms: