Clinical trial NCT02761395: Study of The Therapeutic Benefits of Al-hijamah in Children With Beta Thalassemia Major
Official title: Study of The Therapeutic Benefits of Al-hijamah in Children With Beta Thalassemia Major
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: AL-Hijama in Thalassmia Major
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2016-05-04
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. Evaluate the therapeutic effects, health benefits, and immunological effect of Al-hijamah in children with beta thalassemia major.
2. 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:

1. 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
2. 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.

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

Primary outcomes:
measure: CD(cluster of differentiation)4 and CD8 count
timeFrame: 3month
Secondary outcomes:
measure: serum levels of cholesterol and triglyceride
timeFrame: 3month
measure: alanine amino transferase , aspartate amino transferase
timeFrame: 3month
measure: serum ferritin
timeFrame: 3 months
measure: malodialdehyde ant total antioxidant capacity
timeFrame: 3 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of Medicine- Tanta University
state: Gharbia
city: Tanta
country: Egypt
facility: Faculty of Medicine- Tanta University
state: Gharbia
Study officials:
affiliation: ethical committee
name: Mohamed ELshanshory, prof
role: STUDY_DIRECTOR
References: