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 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201702001512392 Date of Approval: 07/03/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title TRADITIONAL PHYSICAL THERAPY PROGRAM VERSUS TRADITIONAL SIWAN PROGRAM IN THE TREATMENT OF RHEUMATIC PATIENTS
Official scientific title TRADITIONAL PHYSICAL THERAPY PROGRAM VERSUS TRADITIONAL SIWAN PROGRAM IN THE TREATMENT OF RHEUMATIC PATIENTS
Brief summary describing the background and objectives of the trial fourty patients will be assigned into two matched groups (A and B). Group A (Control group): will consist of 20 patients receiving medication only including non-steroid anti inflammatory drugs (NSAIDs), disease-modifying anti-rheumatoid drugs (DMARDs) and biologic agent according to patient and clinical Group B: will consist of 20 patients receiving Siwan traditional therapy. All patients will be asked to sign a consent form (Appendix I) for ethical issue
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,rheumatoid arthritis
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/08/2016
Actual trial start date
Anticipated date of last follow up 12/12/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
non non
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 Non-randomised CENTERAL RANDOMIZATION Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Non-randomised CENTERAL RANDOMIZATION Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group TRADITIONAL PHYSICAL THERAPY PROGRAM day after day two months Hot application, Electrical stimulation (TENS), Exercise. 30
Experimental Group Siwan traditional therapy every day 7days Thirty patients receiving Siwan traditional therapy in form of sand bathing, after that massage with olive oil will be applied, and then patient will drink medicinal herbal. The program will be performed for 7 days. The most beneficial time for sand bath during summer¿s hottest months in June, July and August. There are four steps. "The first is to get buried (best place is near the mountain 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Age ranges from 40 to 75 years old (Barry et al, 1998). ¿ Study conducting on male and female ¿ Patients with mild and moderate rheumatoid arthritis ¿ Pain of at least 3 mm on a visual analogue scale (VAS) from 0 mm (no pain) to 10 mm (worst imaginable pain) (Ziaeifar et al., 2014). ¿ uncontrolled arterial hypertension [systolic blood pressure (SBP) ¿ 200 mm Hg and/or diastolic blood pressure (DBP) ¿ 120 mm Hg] (Nobuyuki Tanaka and Kabira Kazumi, 1990). ¿ Uncontrolled diabetes. ¿ Previous renal transplanted patients. ¿ Patients had coronary artery disease including: unstable angina. ¿ Pregnancy. ¿ Bleeding disorders. ¿ Stroke (Nobuyuki Tanaka and Kabira Kazumi, 1990). 40 Year(s) 75 Year(s) Both
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
Yes 07/06/2015 cariro univerisity
Ethics Committee Address
Street address City Postal code Country
been el sariat street Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Clinical Disease Activity Index (CDAI) pre treatment post treatment after one month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University 43 EL Kaser EL Eny street cairo 12613 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
nashwa allam 2 masjed el rahman rokn helwan el gededa cairo 11731 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor cairo university been el sariat street giza 12613 Egypt University
COLLABORATORS
Name Street address City Postal code Country
nashwa allam 2 masjed el rahaman rokn helwan el gededa cairo 11731 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator nashwa allam gana.yassin@yahoo.com 01153898885 2 masjed el rahman street
City Postal code Country Position/Affiliation
cairo 11731 Egypt physical therapist
Role Name Email Phone Street address
Public Enquiries amr yehia amryehia8152@gmail.com 01159388770 19 iskan el-mohandseen makram ebid extension infront of 1st police station nasr city
City Postal code Country Position/Affiliation
cairo 11759 Egypt physical therapist
Role Name Email Phone Street address
Scientific Enquiries emad mohamed emad9111@live.com 0201146808839 tokh street- qaliubia
City Postal code Country Position/Affiliation
tohk 5243 Egypt physical therapy
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