Benefits of Nigella Sativa in Children With Beta Thalassemia Major

NCT ID: NCT02816957

Last Updated: 2017-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-06-30

Brief Summary

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Evaluate the therapeutic effects health benefits, and immunological effect of Nigella sativa in children with beta thalassemia major.

Detailed Description

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Study will be carried on children patients with β- thalassemia major attending The Hematology Unit of Pediatric Department at Tanta University Hospital. patients are divided into 2 groups: patients in the control group, patients in the treatment group that will receive nigella sativa powder for 3 consecutive months. Then Evaluate the therapeutic effects health benefits, and immunological effect of Nigella sativa in children with beta thalassemia major.

Evaluate the extent of clinical improvement, reductions in serum iron and ferritin, antioxidant status, treatment of the causes of hemolysis and other therapeutic benefits of Nigella sativa in those patient.

Conditions

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Nigella Sativa With Beta Thalassemia Major

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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patients receiving Nigella

40 patients in the treatment group that will receive nigella sativa powder (2 gm/day) for 3 consecutive months.

Group Type ACTIVE_COMPARATOR

nigella sativ

Intervention Type DRUG

nigella sativa powder (2 gm/day) for 3 consecutive months.

patients not received nigella as controls

40 patients in the control group will not receive nigella sativa and continued on the usual chelators

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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nigella sativ

nigella sativa powder (2 gm/day) for 3 consecutive months.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Thalassemia with iron overload

Exclusion Criteria

* Thalassemia complicated with diabetes mellitus or hepatitis
* Patients who discontinue treatment
Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mohamed Ramadan ELshanshory, prof

Role: STUDY_DIRECTOR

professor of pediatrics

Locations

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Faculty of Medicine- Tanta University

Tanta, Gharbia Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Nahed Mohamed Habas, MD

Role: CONTACT

01010560350

Nahed moh Hablas, MD

Role: CONTACT

00201010560350

Facility Contacts

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Mohamed R El-Shanshory, MD

Role: primary

+201005680834

Nahed M Hablas, MD

Role: backup

+201010560350

Other Identifiers

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30794l03l16

Identifier Type: -

Identifier Source: org_study_id

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