AL-Hijama in Thalassmia MajorAl-hijamahNCT02761395
Study of The Therapeutic Benefits of Al-hijamah in Children With Beta Thalassemia Major
A study testing Al-hijamah and Deferasirox in people with AL-Hijama in Thalassmia Major, run by Tanta University at 2 sites in Egypt.
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. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- AL-Hijama in Thalassmia Major
- What is being tested?
- Al-hijamah and Deferasirox
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesEgypt
- Study dates
- Nov 2015to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children suffering from beta thalassemia major, with age range from 4-18 years.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Egypt2 sites, 1 recruiting
- Completed
Faculty of Medicine- Tanta University
Tanta, Gharbia Governorate, 0000
- Recruiting
Faculty of Medicine- Tanta University
Tanta, Gharbia Governorate, 0000
Mohamed R El-Shanshory, MD, +201005680834, elshanshory@gmail.com
Nahed M Hablas, MD, +201010560350, nahedhablas79@gmail.com
About this study
- Evaluate the therapeutic effects, health benefits, and immunological effect of Al-hijamah in children with beta thalassemia major.
- Evaluate the extent of clinical improvement, reductions in serum iron and ferritin, antioxidant status, in those patients.
Read the 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:
- 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
- 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.
- Risks to participants are reasonable in relation to anticipated benefits. Many human studies have proven safety of Al-hijamah.
- 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.
- 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
- Being tested
- Al-hijamah, Deferasirox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Al-hijamahProcedure or surgery
- 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.
DeferasiroxDrug
20-40 mg/kg/day orally
| Study group | Role | What they receive |
|---|---|---|
| Group 1: ALhijama | Experimental | 20 patients under went Al-hijamah procedure for iron chelation Receives: Procedure: Al-hijamah |
| Group 2: AL-hijama with deferasirox | Experimental | 20 patients receive deferasirox and Al-hijamah. Receives: Procedure: Al-hijamah; Drug: Deferasirox |
| Group 3:deferasirox | Active comparator | 20 patients already receiving deferasirox Receives: Drug: Deferasirox |
What is being measured
The primary outcome is the main question the study is designed to answer.
CD(cluster of differentiation)4 and CD8 count
count and percentage
Measured: 3month
Secondary outcomes (4)
serum levels of cholesterol and triglyceride
level of cholesterol and triglyceride (mg per dl)
Measured: 3month
alanine amino transferase , aspartate amino transferase
measured as unit per litre
Measured: 3month
serum ferritin
measured as ng per dl
Measured: 3 months
malodialdehyde ant total antioxidant capacity
measuedas mmol per litre
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startNov 2015
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AL-Hijama in Thalassmia MajorStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed ELshanshory, prof, Study director, ethical committee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02761395
- Sponsor's protocol ID
- 2814/10/14
- Acronym
- Al-hijamah
- Status last verified
- Apr 2016
- First submitted
- 30 Jan 2016
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of The Therapeutic Benefits of Al-hijamah in Children With Beta Thalassemia Major
- ClinicalTrials.gov ID
- NCT02761395
- Acronym / sponsor ID
- Al-hijamah / 2814/10/14
- Conditions
- AL-Hijama in Thalassmia Major
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 4 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Evaluate the therapeutic effects, health benefits, and immunological effect of Al-hijamah in children with beta thalassemia major.
- 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:
- 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
- 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.
- Risks to participants are reasonable in relation to anticipated benefits. Many human studies have proven safety of Al-hijamah.
- 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.
- The proposal include a clear statement that an informed consent will be obtained from all participants in this research.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: ALhijama | Experimental | Procedure: Al-hijamah20 patients under went Al-hijamah procedure for iron chelation |
| Group 2: AL-hijama with deferasirox | Experimental | Procedure: Al-hijamah, Drug: Deferasirox20 patients receive deferasirox and Al-hijamah. |
| Group 3:deferasirox | Active comparator | Drug: Deferasirox20 patients already receiving deferasirox |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Children suffering from beta thalassemia major, with age range from 4-18 years.
Key exclusion criteria (7 listed)
- Children with Congenital heart disease
- Children with Rheumatic heart disease
- Presence of heart failure
- Children with Coronary arterial disease
- Children with Cardiomyopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Group 1: ALhijama, Group 2: AL-hijama with deferasirox |
| Deferasirox20-40 mg/kg/day orally | Drug | Group 2: AL-hijama with deferasirox, Group 3:deferasirox |
Primary outcome
CD(cluster of differentiation)4 and CD8 count
Time frame: 3month
count and percentage
4 secondary outcomes
serum levels of cholesterol and triglyceride
Time frame: 3month
alanine amino transferase , aspartate amino transferase
Time frame: 3month
serum ferritin
Time frame: 3 months
malodialdehyde ant total antioxidant capacity
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed ELshanshory, prof study director
ethical committee
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Al-hijamah and Deferasirox in people with AL-Hijama in Thalassmia Major, run by Tanta University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nahed Habas, MD (01010560350 ext. 002, nahedhablas79@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CD(cluster of differentiation)4 and CD8 count (time frame: 3month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2017.