Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT02761395 |
| Other study ID # |
2814/10/14 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
January 30, 2016 |
| Last updated |
April 24, 2017 |
| Start date |
November 2015 |
| Est. completion date |
May 2017 |
Study information
| Verified date |
April 2016 |
| Source |
Tanta University |
| Contact |
Nahed Habas, MD |
| Phone |
01010560350 |
| Email |
nahedhablas79[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
