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Effect of Pumpkin Seeds Phonophoresis on Chronic Non-bacterial Prostatitis

Primary Purpose

Chronic Non-bacterial Prostatitis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
phonophoresis treatment using pumpkin seeds oil
Sponsored by
Ahlia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Non-bacterial Prostatitis

Eligibility Criteria

40 Years - 55 Years (Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Dr Dalia Kamel
  • Dr Sayed Tanatwy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

No Intervention

Arm Label

Group A

Group B

Group C

Arm Description

phonophoresis treatment using pumpkin seeds oil

Low intensity Ultrasound

Placebo Low intensity Ultrasound

Outcomes

Primary Outcome Measures

NIH Chronic Prostatitis Symptom Index (NIH-CPSI)
Questionnaire

Secondary Outcome Measures

Full Information

First Posted
March 4, 2018
Last Updated
March 8, 2018
Sponsor
Ahlia University
Collaborators
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03461263
Brief Title
Effect of Pumpkin Seeds Phonophoresis on Chronic Non-bacterial Prostatitis
Official Title
Trans-perineal Pumpkin Seeds Phonophoresis as an Adjunct Treatment for Chronic Non-bacterial Prostatitis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 5, 2017 (Actual)
Primary Completion Date
December 13, 2017 (Actual)
Study Completion Date
February 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ahlia University
Collaborators
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Non-bacterial Prostatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
phonophoresis treatment using pumpkin seeds oil
Arm Title
Group B
Arm Type
No Intervention
Arm Description
Low intensity Ultrasound
Arm Title
Group C
Arm Type
No Intervention
Arm Description
Placebo Low intensity Ultrasound
Intervention Type
Other
Intervention Name(s)
phonophoresis treatment using pumpkin seeds oil
Intervention Description
phonophoresis treatment using pumpkin seeds oil
Primary Outcome Measure Information:
Title
NIH Chronic Prostatitis Symptom Index (NIH-CPSI)
Description
Questionnaire
Time Frame
3 weeks

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
males with CNBP
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sayed A Tantawy
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Dr Dalia Kamel
City
Giza
Country
Egypt
Facility Name
Dr Sayed Tanatwy
City
Giza
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Pumpkin Seeds Phonophoresis on Chronic Non-bacterial Prostatitis

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