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

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.

Study Overview

• Status: Unknown
• Conditions: AL-Hijama in Thalassmia Major
• Intervention / Treatment: Procedure: Al-hijamah; Drug: Deferasirox

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nahed Habas, MD; Phone Number: 002 01010560350; Email: nahedhablas79@gmail.com
• Study Contact Backup: Name: Mohammed El shanshoryR, Prof.; Phone Number: 002 01005680834; Email: elshanshory@hotmail.com

Study Locations

• Egypt
  • Gharbia
    • Tanta, Gharbia, Egypt, 0000
      • Completed
      • Faculty of Medicine- Tanta University
    • Tanta, Gharbia, Egypt, 0000
      • Recruiting
      • Faculty of Medicine- Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 16 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: ALhijama; 20 patients under went Al-hijamah procedure for iron chelation	Procedure: Al-hijamah; 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.
Experimental: Group 2: AL-hijama with deferasirox; 20 patients receive deferasirox and Al-hijamah.	Procedure: Al-hijamah; 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.; Drug: Deferasirox; 20-40 mg/kg/day orally
Active Comparator: Group 3:deferasirox; 20 patients already receiving deferasirox	Drug: Deferasirox; 20-40 mg/kg/day orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CD(cluster of differentiation)4 and CD8 count	count and percentage	3month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum levels of cholesterol and triglyceride	level of cholesterol and triglyceride (mg per dl)	3month
alanine amino transferase , aspartate amino transferase	measured as unit per litre	3month
serum ferritin	measured as ng per dl	3 months
malodialdehyde ant total antioxidant capacity	measuedas mmol per litre	3 months

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Study Director: Mohamed ELshanshory, prof, Ethical Committee

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Anticipated): May 1, 2017
• Study Completion (Anticipated): May 1, 2017

Study Registration Dates

• First Submitted: January 30, 2016
• First Submitted That Met QC Criteria: May 1, 2016
• First Posted (Estimate): May 4, 2016

Study Record Updates

• Last Update Posted (Actual): April 25, 2017
• Last Update Submitted That Met QC Criteria: April 24, 2017
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Thalassemia; beta-Thalassemia; Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Iron Chelating Agents; Deferasirox
• Other Study ID Numbers: 2814/10/14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided