Effect of Pumpkin Seeds Phonophoresis on Chronic Non-bacterial Prostatitis

March 8, 2018 updated by: Dr Sayed Tantawy, Ahlia University

Trans-perineal Pumpkin Seeds Phonophoresis as an Adjunct Treatment for Chronic Non-bacterial Prostatitis

It has been observed that out of all visits to the clinics by the young and middle age men for grievances including the genital and urinary frameworks, about 25% of the visits account for Prostatitis. A significant number of men, aged less than 50, visits to urologist due to Interminable prostatitis. Nevertheless, just 5 to10% of "prostatitis" cases is really caused by a bacterial contamination.

The purpose was to investigate thoroughly the effect of pumpkin seeds oil phonophoresis among males who are diagnosed with chronic non-bacterial prostatitis.

Study Overview

Detailed Description

sixty male outpatients diagnosed with chronic non-bacterial prostatitis. Through sample random sampling procedure the total study population was categorized into three treatment groups; Group A, wherein patients received phonophoresis treatment using pumpkin seeds oil; Group B, where members of the group received trans-perineal continuous low-intensity ultrasound; and Group C, in which the participant received placebo low- intensity ultrasound. All of The three groups of the organized trail received their corresponding treatment daily up-to 3 weeks.

For the analysis participants were recruited from a registry of patients with a diagnosis of CNBP. To be included in the analysis a patient must be evaluated with a confirmed diagnosis. They were examined and diagnosed accordingly by a medical practitioner/urologist.

Patients with concomitant infection, autoimmune diseases, diabetes mellitus, cancer, heart problems/pacemaker, implants (metal, silicone, saline), acute and post-acute injury, thrombophlebitis, impaired sensation, psychiatric diseases, and those with well-known contraindications of ultrasound treatment were excluded from the study. Similarly, those with known hypersensitivity to pumpkin seeds oil and its derivatives, along with those who had received other forms of therapies that could influence the therapeutic outcomes of the study were excluded from the study sample.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Giza, Egypt
        • Dr Dalia Kamel
      • Giza, Egypt
        • Dr Sayed Tanatwy

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

40 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • For the analysis participants were recruited from a registry of patients with a diagnosis of CNBP. To be included in the analysis a patient must be evaluated with a confirmed diagnosis. They were examined and diagnosed accordingly by a medical practitioner/urologist. The patients who were included in the study should have normal laboratory findings

Exclusion Criteria:

  • Patients with concomitant infection, autoimmune diseases, diabetes mellitus, cancer, heart problems/pacemaker, implants (metal, silicone, saline), acute and post-acute injury, thrombophlebitis, impaired sensation, psychiatric diseases, and those with well-known contraindications of ultrasound treatment were excluded from the study. Similarly, those with known hypersensitivity to pumpkin seeds oil and its derivatives, along with those who had received other forms of therapies that could influence the therapeutic outcomes of the study were excluded from the study sample.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
phonophoresis treatment using pumpkin seeds oil
phonophoresis treatment using pumpkin seeds oil
No Intervention: Group B
Low intensity Ultrasound
No Intervention: Group C
Placebo Low intensity Ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NIH Chronic Prostatitis Symptom Index (NIH-CPSI)
Time Frame: 3 weeks
Questionnaire
3 weeks

Collaborators and Investigators

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

Collaborators

Investigators

  • Study Director: Sayed A Tantawy, Cairo University

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 (Actual)

January 5, 2017

Primary Completion (Actual)

December 13, 2017

Study Completion (Actual)

February 19, 2018

Study Registration Dates

First Submitted

March 4, 2018

First Submitted That Met QC Criteria

March 8, 2018

First Posted (Actual)

March 12, 2018

Study Record Updates

Last Update Posted (Actual)

March 12, 2018

Last Update Submitted That Met QC Criteria

March 8, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • No: P. T. REC/ 012/001810

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

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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