- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03461263
Effect of Pumpkin Seeds Phonophoresis on Chronic Non-bacterial Prostatitis
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
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Giza, Egypt
- Dr Dalia Kamel
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Giza, Egypt
- Dr Sayed Tanatwy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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No Intervention: Group B
Low intensity Ultrasound
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|
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No Intervention: Group C
Placebo Low intensity Ultrasound
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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
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3 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Sayed A Tantawy, Cairo University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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