Study of The Therapeutic Benefits of Al-hijamah in Children With Beta Thalassemia Major

Tanta University

Status: Unknown

Conditions: AL-Hijama in Thalassmia Major

Treatments: Procedure: Al-hijamah; Drug: Deferasirox

Study type: Interventional

Funder types: Other

Identifiers

NCT02761395

2814/10/14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 4 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

Group 1: ALhijama

Experimental group

Description:

20 patients under went Al-hijamah procedure for iron chelation

Treatment:

Procedure: Al-hijamah

Group 2: AL-hijama with deferasirox

Experimental group

Description:

20 patients receive deferasirox and Al-hijamah.

Treatment:

Drug: Deferasirox

Procedure: Al-hijamah

Group 3:deferasirox

Active Comparator group

Description:

20 patients already receiving deferasirox

Treatment:

Drug: Deferasirox