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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03461263
Other study ID # No: P. T. REC/ 012/001810
Secondary ID
Status Completed
Phase N/A
First received March 4, 2018
Last updated March 8, 2018
Start date January 5, 2017
Est. completion date February 19, 2018

Study information

Verified date March 2018
Source Ahlia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date February 19, 2018
Est. primary completion date December 13, 2017
Accepts healthy volunteers No
Gender Male
Age group 40 Years to 55 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
phonophoresis treatment using pumpkin seeds oil
phonophoresis treatment using pumpkin seeds oil

Locations

Country Name City State
Egypt Dr Dalia Kamel Giza
Egypt Dr Sayed Tanatwy Giza

Sponsors (2)

Lead Sponsor Collaborator
Ahlia University Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary NIH Chronic Prostatitis Symptom Index (NIH-CPSI) Questionnaire 3 weeks
See also
  Status Clinical Trial Phase
Active, not recruiting NCT01714830 - Efficacy of Extracorporal Shock Wave Therapy in Patient With Chronic Non-bacterial Prostatitis / Chronic Pelvic Pain Syndrome N/A