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.: PACTR202002466895205 Date of Approval: 20/02/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy and safety of Glucosamine sulfate and chondroitin sulfate combination in the treatment of haemophilic arthropathy: randomized, double-blind, placebo-controlled trial
Official scientific title Efficacy and safety of Glucosamine sulfate and chondroitin sulfate combination in the treatment of haemophilic arthropathy: randomized, double-blind, placebo-controlled trial
Brief summary describing the background and objectives of the trial Haemophilia is an X-linked heritable coagulopathy caused by deficiency in clotting factor VIII deficiency (haemophilia A) or Factor IX deficiency (haemophilia B). Severity of the disease depends on the level of the circulating factor. Haemarthrosis (intra articular bleeding) is the most common clinical manifestation, and the knees, ankles and elbows are most frequently affected. Due to cost and lack of specialized care, access to replacement therapy is, to a large extent, limited to developed countries only. In Khartoum haemophilia clinic (KHC), there is no prophylactic therapy for patients and the factor replacement therapy is administered only on demand and it is very costly. The pathogenesis of haemophilic arthropathy resembles degenerative joint damage as found in osteoarthritis. The combination of Glucosamine Sulphate and Chondroitin sulphate in treatment of osteoarthritis is associated with significant reductions in pain and improvements in functioning, with decreased analgesic consumption and preventing radiographic progression of the disease. Objectives: To assess the safety and clinical efficacy of glucosamine sulfate and chondroitin sulphate combination on pain, function, and radiological progression in the treatment of haemophilic arthropathy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/03/2020
Actual trial start date
Anticipated date of last follow up 14/06/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants)
Recruitment status Recruiting
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Glucosamine sulphate and chondroitin sulphate combination Age group 1(5-13 years) 125mg glucosamine sulphate/100mg chondroitin sulphate Age group 2(14-18 years) 175mg glucosamine sulphate/132.5mg chondroitin sulphate Age group 3(>18 years) 250mg glucosamine sulphate/200mg chondroitin sulphate The dose is: 2 capsules three times per day. 3 months Each participant will receive 2 capsules three times per day according to the age group (as described above) for total period of three months. 15
Experimental Group Glucosamine sulphate and chondroitin sulphate combination Age group 1(5-13 years) 125mg glucosamine sulphate/100 mg chondroitin sulphate Age group 2(14-18 years) 175mg glucosamine sulphate/132.5 mg chondroitin sulphate Age group 3(>18 years) 250mg glucosamine sulphate/200 mg chondroitin sulphate The participant will take 2 capsules 2 times per day 3 months Each participants will receive 2 capsules 2 times per day (according to age group of the participant as described above) for total of 3 months. 15
Control Group Placebo Participants in this group will receive capsules similar in color, shape, and size to the active capsules. The dose will be either 2 capsules 3 times per day or 2 capsules 2 times daily. 3 months Participants in this group will receive capsules similar in color, shape, and size to the active capsules. The dose will be either 2 capsules 3 times per day or 2 capsules 2 times daily for total of 3 months. 15 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• patients diagnosed as having haemophilia A or B, • patients at least 5 years old at the time of enrollment, • patients classified as having haemophilc arthropathy in Arnold-Hilgartner scale, • no concurrent medical or arthritic conditions that could confound evaluation of the index joint, • No other active or severe diseases. • Patients with bleeding disorders other than haemophilia A and B, • Patients less than 5 years old, • Patients with severe haemophilic arthropathy classified as class O, or IV in Arnold-Hilgartner scale of haemophilic arthropathy, • Patients with positive results in HIV, HB, or HC screening tests. • a history of clinically significant trauma or surgery to the joints, • Or coexisting disease that could preclude successful completion of the trial. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Child: 6 Year-12 Year 5 Year(s) 45 Year(s) Male
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 01/07/2015 Ethics Reserch Commitee University of Khartoum Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
Alqasr street Khartoum 11111 Sudan
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Improvement of participant sore in the clinical evaluation of haemophilic arthropathy scale. At enrollement, after 6 weeks, and at 12 weeks.
Primary Outcome Improvement of participant score in radiological evaluation using Arnold-Hilgartner scale of haemophilic arthropathy. At enrollement, after 6 weeks, and at 12 weeks.
Secondary Outcome Quality of life At enrollement, and at 12 weeks.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Khartoum haemophilia clinic. Isbitalia street Khartoum Sudan
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Pharmacy University of Khartoum Alqasr street Khartoum 11111 Sudan
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of pharmacy university of khartoum Alqasr street Khartoum 11111 Sudan University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mawahib Mohammed mus.mawahib@gmail.com 00249909606115 Alqasr street
City Postal code Country Position/Affiliation
Khartoum 11111 Sudan Lecturer at faculty of pharmacy university of Khartoum
Role Name Email Phone Street address
Principal Investigator Samir Shaheen drsshaheen@hotmail.com 00249912376929 Alqasr street
City Postal code Country Position/Affiliation
Khartoum 11111 Sudan Proffesor of Paediatric orthopedics
Role Name Email Phone Street address
Scientific Enquiries Bashier Osman dbashier@gmail.com 00249918384627 Alqasr street
City Postal code Country Position/Affiliation
Khartoum 11111 Sudan Dean faculty of pharmacy university of khartoum
Role Name Email Phone Street address
Public Enquiries Ahmed Mudawi Musa musaam2003@yahoo.co.uk 00249918043288 Alqasr street
City Postal code Country Position/Affiliation
Khartoum 11111 Sudan Profeesor at institute of endemic diseases university of Khartoum
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Clinical Study Report,Informed Consent Form Beginning 3 months and ending 3 years following article publication. Investigators whose proposed use of the data has been approved by an independent review committee.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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