Effect of Pumpkin Seeds Phonophoresis on Chronic Non-bacterial Prostatitis

NCT03461263 | Completed DMC

• 1 other identifier: No: P. T. REC/ 012/001810
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Non-bacterial Prostatitis

Outcome Measures

Primary Outcomes (1)

• NIH Chronic Prostatitis Symptom Index (NIH-CPSI)

  Questionnaire

  3 weeks

Study Arms (3)

Group A

ACTIVE COMPARATOR

phonophoresis treatment using pumpkin seeds oil

Other: phonophoresis treatment using pumpkin seeds oil

Group B

NO INTERVENTION

Low intensity Ultrasound

Group C

NO INTERVENTION

Placebo Low intensity Ultrasound

Interventions

phonophoresis treatment using pumpkin seeds oil OTHER

phonophoresis treatment using pumpkin seeds oil

Group A

Eligibility Criteria

• Age: 40 Years - 55 Years
• Gender Eligibility Details: males with CNBP
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ahlia University: lead
• Cairo University: collaborator

Study Sites (2)

Dr Dalia Kamel

Giza, Egypt

Location

Dr Sayed Tanatwy

Giza, Egypt

Location

Study Officials

• Sayed A Tantawy

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 4, 2018
• First Posted: March 12, 2018
• Study Start: January 5, 2017
• Primary Completion: December 13, 2017
• Study Completion: February 19, 2018
• Last Updated: March 12, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)