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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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27 June 2016 |
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Main ID: |
NCT02804581 |
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Date of registration:
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15/06/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Gum Arabic as Immunomodulator In Rheumatoid Arthritis Patients
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Scientific title:
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Potential Role of Gum Arabic as Immunomodulator In Sudanese Rheumatoid Arthritis Patients |
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Date of first enrolment:
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June 2016 |
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Target sample size:
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45 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02804581 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Sudan
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Contacts
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Name:
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Alnour Elagib, MBBS,MRCP,MD |
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Address:
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Telephone:
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00249912306262 |
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Email:
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elagib62@hotmail.com |
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Affiliation:
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Name:
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Amal M Saeed, MBBS,PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Khartoum |
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Name:
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Ebtihal K Obied, MBBS |
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Address:
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Telephone:
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. 00249912279229 |
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Email:
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E.Kamal.Ali@hotmail.com |
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Affiliation:
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Name:
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Alnour Alagib, MBBS,MD,MRCP |
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Address:
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Telephone:
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Email:
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Affiliation:
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Military hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Clinical diagnosis of Rheumatoid Arthritis
2. Clinically stable as evidenced by medical history, complete physical examination
3. All medications and dosages are stable for 6 weeks before study entry,
4. Non Pregnant ladies.
Exclusion Criteria:
- 1- hepatic, cardiovascular, pulmonary, malignant, hematologic, neurologic,
infectious, or inflammatory diseases unrelated to Rheumatoid arthritis.
2-Hospital admission within 4 weeks of start of the study.
3- Uncontrolled hypertension 4- Asthma or severe atopic disease;
Age minimum:
20 Years
Age maximum:
50 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Dietary Supplement: Gum Arabic
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Primary Outcome(s)
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The level of C reactive protein (CRP)and Tumer necrosis factor alpha TNF
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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Total anti-oxidant capacity (TAC), malondialdehyde (MDA) and hydrogen peroxide (H2O2) level
[Time Frame: 12 weeks]
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clinical improvement
[Time Frame: 12 weeks]
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Secondary ID(s)
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University of Khartoum
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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