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.: PACTR201111000337258 Date of Registration: 10/11/2011
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Clinical validation of Grewia tenax fruits extract chewble tablets in treatment of iron deficiency anemia [retrospectively registered]
Official scientific title Randomized control trial to validate Grewi tenax fruits extract chewable tablets in the treatment of iron deficiency anemia in adults. A pilot study
Brief summary describing the background and objectives of the trial Grewia tenax fruits extract is the traditional remedy used by many Sudanese people to replinish body iron stores specially for those at higher risk of iron deficiency; children, menstruating females, pregnant and lactating women. objectives are to compare Grewia tenax fruits extract chewable tablets to the active control which is the standard oral ferrous gluconate tablets used to treat iron deficiency anemia and to compare the reported adverse effects with each
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Haematological Disorders,iron deficiency and iron deficiency anemia,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 06/06/2011
Actual trial start date 15/08/2011
Anticipated date of last follow up 29/12/2011
Actual Last follow-up date
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants) 70
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 By tossing a coin to allocate subjects simple randomization by tossing a coin Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised By tossing a coin to allocate subjects simple randomization by tossing a coin Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Ferrous gluconate tablets 300 mg tablet three times daily 4 weeks Oral tablets 35 Active-Treatment of Control Group
Experimental Group Grewia tenax fruits extract Grewia tenax fruits extract 5 chewable tablets (2.5 g) twice per day 4 weeks Chewable tablets 500 mg tablets 35
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria: Volunteer adults 18 years and older diagnosed and confirmed to have iron deficiency whose hemoglobin measurements are 78% g/dl or less who may or may not have iron deficiency symptoms to be recruited after signing an informed consent. Exclusion Criteria: Other types of anemias other than iron deficiency GIT disorders that may interfere with oral absorption All hemoglobinopathies and blood disorders Other comorbidities that may confound the results outcome as seen by the supervising physicians 18 Year(s) 65 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 The ferdral Minstry of health in Sudan
Ethics Committee Address
Street address City Postal code Country
Sudanese Minstry of health Sudan
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Hemoglobin level, reticulocyte count and full iron profile hemoglobin level, reticulocyte count baseline and every one week. iron profile including serum iron, serum ferritin, tranferrin and total iron binding capacity at baseline and at the end of treatment Both for 4 weeks
Secondary Outcome Reported adverse effects with each treatment arm and clinical improvement of anemia Adverse effects reported at all time points of checking on weekly basis. Clinical improvement or / and disappearance of anemic symptoms on weekly basis
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Science & Technology- Faculty of Pharmacy Omdurman Alnus Street Khartoum 11111 Sudan
FUNDING SOURCES
Name of source Street address City Postal code Country
Privately by the researcher: Randa AlSadig AlMahdi University of Science & Technology Khartoum 11111 Sudan
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Randa AlMahdi P O Box 11580 Khartoum 11111 Sudan University
COLLABORATORS
Name Street address City Postal code Country
AlNailain medical center Baladiah street Khartoum 11111 Sudan
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Randa AlMahdi randa_almahdi@yahoo.com 00249912147698 P O Box 11580
City Postal code Country Position/Affiliation
Khartoum 11111 Sudan primary investigator
Role Name Email Phone Street address
Principal Investigator Randa AlMahdi randa_almahdi@yahoo.com 00249912147698 P O Box 11580
City Postal code Country Position/Affiliation
Khartoum 11111 Sudan pricipal investigator and sponsor
Role Name Email Phone Street address
Public Enquiries Randa AlMahdi randa_almahdi@yahoo.com 00249912147698 P O Box 11580
City Postal code Country Position/Affiliation
Khartoum 11111 Sudan primary investigator
Role Name Email Phone Street address
Scientific Enquiries Sami Khalid khalidseek@hotmail.com 00249912146087 AlNus street
City Postal code Country Position/Affiliation
Khartoum 11111 Sudan Scientific Supervisor
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