Prostatic Hyperplasia Treatment and Cancer Prevention

February 24, 2021 updated by: DR. VINOD C TAWAR, Manchanda Medical Clinic

Treatment of Prostatic Hyperplasia With Topical Papaverine

Treatment of patients with prostatic hyperplasia with topical papaverine.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients with obstructive voiding and high PSA to be studied for the regression of symptoms and declining PSA.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug free base as placebo
Other: Placebo
observation of skin changes if any
Other Names:
  • drug free base
Experimental: group two- papaverine arm
papaverine in a suitable base
Drug: papaverine
observation of symptoms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Laboratory tests to measure regression of symptoms
Time Frame: every 4 weeks up to 16 weeks
patients follow-up on regular intervals
every 4 weeks up to 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Manchanda Medical Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 30, 2021

Primary Completion (Anticipated)

September 30, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

December 12, 2016

First Submitted That Met QC Criteria

February 21, 2017

First Posted (Actual)

February 27, 2017

Study Record Updates

Last Update Posted (Actual)

February 25, 2021

Last Update Submitted That Met QC Criteria

February 24, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tawar - 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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