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

NCT ID: NCT02761395

Last Updated: 2017-04-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2017-05-31

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.

Conditions

AL-Hijama in Thalassmia Major

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group 1: ALhijama

20 patients under went Al-hijamah procedure for iron chelation

Group Type: EXPERIMENTAL

Al-hijamah

Intervention Type: PROCEDURE

• 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.

Group 2: AL-hijama with deferasirox

20 patients receive deferasirox and Al-hijamah.

Group Type: EXPERIMENTAL

Al-hijamah

Intervention Type: PROCEDURE

• 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.

Deferasirox

Intervention Type: DRUG

20-40 mg/kg/day orally

Group 3:deferasirox

20 patients already receiving deferasirox

Group Type: ACTIVE_COMPARATOR

Deferasirox

Intervention Type: DRUG

20-40 mg/kg/day orally

Interventions

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.

Intervention Type: PROCEDURE

Deferasirox

20-40 mg/kg/day orally

Intervention Type: DRUG

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohamed ELshanshory, prof

Role: STUDY_DIRECTOR

ethical committee

Locations

Faculty of Medicine- Tanta University

Tanta, Gharbia Governorate, Egypt

Site Status: COMPLETED

Faculty of Medicine- Tanta University

Tanta, Gharbia Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Nahed Habas, MD

Role: CONTACT

nahedhablas79@gmail.com

01010560350 ext. 002

Mohammed El shanshoryR, Prof.

Role: CONTACT

elshanshory@hotmail.com

01005680834 ext. 002

Facility Contacts

Mohamed R El-Shanshory, MD

Role: primary

elshanshory@gmail.com

+201005680834

Nahed M Hablas, MD

Role: backup

nahedhablas79@gmail.com

+201010560350

Other Identifiers

2814/10/14

Identifier Type: -

Identifier Source: org_study_id