Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201601001389237 Date of Registration: 15/12/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EFFECT OF BEE VENOM PHONOPHORESIS IN TREATING CHRONIC PELVIC INFLAMMATORY DISEASE
Official scientific title EFFECT OF BEE VENOM PHONOPHORESIS IN TREATING CHRONIC PELVIC INFLAMMATORY DISEASE
Brief summary describing the background and objectives of the trial This study investigated the efficacy of bee venom phonophoresis in treating chronic pelvic inflammatory disease in a randomized, placebo-controlled, double-blinded study. Pelvic inflammatory disease (PID) is an infectious and inflammatory disorder of the upper female genital tract.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology,pelvic inflammatory disease
Sub-Disease(s) or condition(s) being studied pelvic inflammatory disease
Purpose of the trial Treatment: Other
Anticipated trial start date 10/12/2015
Actual trial start date 14/12/2015
Anticipated date of last follow up 10/01/2016
Actual Last follow-up date 15/01/2016
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants) 45
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised random envelopes methods Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group group (A) doxycycline100 mg orally 1 month medical treatment only 15 Dose Comparison
Experimental Group group (B) doxycycline100 mg orally in addition to ultrasound therapy 1 month medical treatment and ultrasound intervention 15 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age were ranged from (20-38) complained from lower. abdominal pain radiating to back with abnormal vaginal discharge. they were not responded to any previous medical treatmen free from skin diseases, diabetes, tubo overian abcess, hemorrhage, pelvic tumor as well as sacroiliac joint pain 20 Year(s) 38 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 15/12/2015 faculty of physical therapy ethical committee
Ethics Committee Address
Street address City Postal code Country
elgaesh street kaferelshiek 33351 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain after 1 month of treatment
Secondary Outcome abnormal vaginal discharge 1 month after treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
outpatient clinic of kaferelshiek university elgaesh street kafereishiek 33351 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
faculty of physical therapy elgaesh street kafereishiek 33351 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of physical therapy elgaesh street kafereishiek 33351 Egypt University
COLLABORATORS
Name Street address City Postal code Country
mahmoud mohamed ewidea 3 elwehda street kafereishiek 33512 Egypt
Eman mohamed abdelftah sedi salem kafereishiek 22441 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mahmoud Ewidea mewidea@hotmail.com 01005098423 3 elwehda street
City Postal code Country Position/Affiliation
kaferelshiek 33512 Egypt ass prof
Role Name Email Phone Street address
Public Enquiries eman abdelftah emanabdelfatah123@yahoo.com 01233546721 said salem
City Postal code Country Position/Affiliation
kaferelshiek 22441 Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries Mahmoud Ewidea mewidea@hotmail.com 01005098423 3 elwehda street
City Postal code Country Position/Affiliation
kaferelshiek 33512 Egypt ass prof
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information