Study of The Therapeutic Benefits of Al-hijamah in Children With Beta Thalassemia Major (Al-hijamah)
Primary Purpose
AL-Hijama in Thalassmia Major
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Al-hijamah
Deferasirox
Sponsored by
About this trial
This is an interventional treatment trial for AL-Hijama in Thalassmia Major
Eligibility Criteria
Inclusion Criteria:
- Children suffering from beta thalassemia major, with age range from 4-18 years.
Exclusion Criteria:
- Children with Congenital heart disease
- Children with Rheumatic heart disease
- Presence of heart failure
- Children with Coronary arterial disease
- Children with Cardiomyopathy
- Children with hypotension
- Children with inflammatory skin diseases e.g. acute burns
Sites / Locations
- Faculty of Medicine- Tanta University
- Faculty of Medicine- Tanta UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Group 1: ALhijama
Group 2: AL-hijama with deferasirox
Group 3:deferasirox
Arm Description
20 patients under went Al-hijamah procedure for iron chelation
20 patients receive deferasirox and Al-hijamah.
20 patients already receiving deferasirox
Outcomes
Primary Outcome Measures
CD(cluster of differentiation)4 and CD8 count
count and percentage
Secondary Outcome Measures
serum levels of cholesterol and triglyceride
level of cholesterol and triglyceride (mg per dl)
alanine amino transferase , aspartate amino transferase
measured as unit per litre
serum ferritin
measured as ng per dl
malodialdehyde ant total antioxidant capacity
measuedas mmol per litre
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02761395
Brief Title
Study of The Therapeutic Benefits of Al-hijamah in Children With Beta Thalassemia Major
Acronym
Al-hijamah
Official Title
Study of The Therapeutic Benefits of Al-hijamah in Children With Beta Thalassemia Major
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
May 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tanta University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Evaluate the therapeutic effects, health benefits, and immunological effect of Al-hijamah in children with beta thalassemia major.
Evaluate the extent of clinical improvement, reductions in serum iron and ferritin, antioxidant status, in those patients.
Detailed Description
The present study will be carried on 60 children patients with β- thalassemia major attending The Hematology Unit of Paediatric Departments at Tanta University Hospital. Participants will divide into 3 groups:
Group 1: 20 patients receive Al-hijamah.
Group 2: 20 patients receive Al-hijamah plus iron chelation therapy.
Group 3: 20 patients receive iron chelation therapy only
Participants undergo:
Laboratory investigations:
CBC (complete blood count) of peripheral venous blood before Al-hijamah and daily after it.
Differences between CBC from venous blood and cupped blood (bloody excretion collected inside suction cups). Cupped blood is collected in heparin coated with and added to suction cups put on the skin surface.
• Serum iron and ferritin before Al-hijamah and after it.
• Serum iron and ferritin in cupped blood vs venous blood.
• Serum lipid profile and glycosylated hemoglobin before Al-hijamah and after it.
Total antioxidant capacity and some serum oxidants e.g. malondialdehyde before and after treatment
Flow cytometric analysis of number of Natural killer cells, CD4 T helper cells and CD4/CD8 cells (optional) (cluster of differentiation). They were reported to improve markedly after Al-hijamah.
Estimating serum LDH, pyruvate (antioxidant) and lactate (metabolite of pyruvate through LDH) in thalassemia patients before and after Al-hijamah
Assessment of heart function by Echocardiographic study (before and 3 month after Al-hijamah):
lines of therapy:
Technical steps of Al-hijamah (Necessary equipments are ready and can do it for all patients if possible):
Al-hijamah (Triple S technique under strict sterilization):
Strict sterilization of selected anatomical sites.
Suction using sterile plastic disposable sucking cups
Skin scarifications (shartat mihjam): through inducing superficial (0.1 mm in depth), small (2 mm in length), multiple and evenly distributed skin incisions.
Suction using sterile plastic disposable sucking cups
Strict sterilization of selected anatomical sites.
Study endpoint:
This study will be terminated if safety of the patient were in dangers due to elements related to the new therapeutic agent or if the treatment not proven efficacious.
5. Risks to participants are reasonable in relation to anticipated benefits. Many human studies have proven safety of Al-hijamah.
6. Compensations of controls for transportation or work absence and of patients for any injury, and if so, description of the compensation should be mentioned.
No, compensations.
7. The proposal include a clear statement that an informed consent will be obtained from all participants in this research.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AL-Hijama in Thalassmia Major
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1: ALhijama
Arm Type
Experimental
Arm Description
20 patients under went Al-hijamah procedure for iron chelation
Arm Title
Group 2: AL-hijama with deferasirox
Arm Type
Experimental
Arm Description
20 patients receive deferasirox and Al-hijamah.
Arm Title
Group 3:deferasirox
Arm Type
Active Comparator
Arm Description
20 patients already receiving deferasirox
Intervention Type
Procedure
Intervention Name(s)
Al-hijamah
Intervention Description
Strict sterilization of selected anatomical sites.
Suction using sterile plastic disposable sucking cups
Skin scarifications (shartat mihjam): through inducing superficial (0.1 mm in depth), small (2 mm in length), multiple and evenly distributed skin incisions.
Intervention Type
Drug
Intervention Name(s)
Deferasirox
Intervention Description
20-40 mg/kg/day orally
Primary Outcome Measure Information:
Title
CD(cluster of differentiation)4 and CD8 count
Description
count and percentage
Time Frame
3month
Secondary Outcome Measure Information:
Title
serum levels of cholesterol and triglyceride
Description
level of cholesterol and triglyceride (mg per dl)
Time Frame
3month
Title
alanine amino transferase , aspartate amino transferase
Description
measured as unit per litre
Time Frame
3month
Title
serum ferritin
Description
measured as ng per dl
Time Frame
3 months
Title
malodialdehyde ant total antioxidant capacity
Description
measuedas mmol per litre
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children suffering from beta thalassemia major, with age range from 4-18 years.
Exclusion Criteria:
Children with Congenital heart disease
Children with Rheumatic heart disease
Presence of heart failure
Children with Coronary arterial disease
Children with Cardiomyopathy
Children with hypotension
Children with inflammatory skin diseases e.g. acute burns
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nahed Habas, MD
Phone
01010560350
Ext
002
Email
nahedhablas79@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammed El shanshoryR, Prof.
Phone
01005680834
Ext
002
Email
elshanshory@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed ELshanshory, prof
Organizational Affiliation
ethical committee
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Medicine- Tanta University
City
Tanta
State/Province
Gharbia
ZIP/Postal Code
0000
Country
Egypt
Individual Site Status
Completed
Facility Name
Faculty of Medicine- Tanta University
City
Tanta
State/Province
Gharbia
ZIP/Postal Code
0000
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed R El-Shanshory, MD
Phone
+201005680834
Email
elshanshory@gmail.com
First Name & Middle Initial & Last Name & Degree
Nahed M Hablas, MD
Phone
+201010560350
Email
nahedhablas79@gmail.com
First Name & Middle Initial & Last Name & Degree
Mohamed M El-Shanshory, MD
First Name & Middle Initial & Last Name & Degree
Nahed AR Hablas, MD
First Name & Middle Initial & Last Name & Degree
Salah M El Sayed, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Study of The Therapeutic Benefits of Al-hijamah in Children With Beta Thalassemia Major
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