Nigella Sativa With Beta Thalassemia MajorEarly Phase 1NigellaNCT02816957
Benefits of Nigella Sativa in Children With Beta Thalassemia Major
A Early Phase 1 study testing nigella sativ in people with Nigella Sativa With Beta Thalassemia Major, run by Tanta University at 1 site in Egypt.
Trial summary
Evaluate the therapeutic effects health benefits, and immunological effect of Nigella sativa in children with beta thalassemia major. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Nigella Sativa With Beta Thalassemia Major
- What is being tested?
- nigella sativ
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2016to Jun 2017
- Phase
- Early Phase 1
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Thalassemia with iron overload
Who cannot join
- Thalassemia complicated with diabetes mellitus or hepatitis
- Patients who discontinue treatment
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- 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
Official title: Study of The Therapeutic Benefits of Nigella Sativa in Children With Beta Thalassemia Major
Evaluate the therapeutic effects health benefits, and immunological effect of Nigella sativa in children with beta thalassemia major.
Read the detailed description
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.
- Being tested
- nigella sativ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nigella sativDrug
nigella sativa powder (2 gm/day) for 3 consecutive months.
| Study group | Role | What they receive |
|---|---|---|
| patients receiving Nigella | Active comparator | 40 patients in the treatment group that will receive nigella sativa powder (2 gm/day) for 3 consecutive months. Receives: Drug: nigella sativ |
| patients not received nigella as controls | No intervention | 40 patients in the control group will not receive nigella sativa and continued on the usual chelators |
What is being measured
The primary outcome is the main question the study is designed to answer.
malondialdehyde
nmol serum level of malondialdehyde (nmol per liter)
Measured: 3 months
cluster of differentation4 and 8(CD4 and CD8)
CD4 and CD8 cell per cmm
Measured: 3 months
total antioxidant
total antioxidant(mmol per liter)
Measured: 3 months
Secondary outcomes (4)
Serum iron
microgram per dl
Measured: 3 months
total iron binding capacity
microgram per dl
Measured: 3 months
serum ferritin
ng per ml
Measured: 3 months
complete blood count
complete blood count
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 posted29 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nigella Sativa With Beta Thalassemia 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed Ramadan ELshanshory, prof, Study director, professor of pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02816957
- Sponsor's protocol ID
- 30794l03l16
- Acronym
- Nigella
- Status last verified
- Jun 2016
- First submitted
- 23 Jun 2016
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Abdelshafy M, El Shanshory M, Shahat K, Al Jaouni SK, Attia M, Hamous SAA, Aboonq MS, Saad AA, Alayoubi AM, Bahashwan AS, Alhussaini AMT, Abdel-Latif HM, Albeihany AM, Hemdan SB, Yousef RS, Aloufi HA, Alsaedi AM, Alsaedi K, Eid RM, Mohamed N, Abdellah WA, Afifi TM, El Sayed SM, Hablas N. Immunological, hematological and biochemical benefits of adjuvant nigella sativa to pharmacotherapy in immune thrombocytopenic purpura patients. Am J Blood Res. 2026 Feb 15;16(1):1-13. doi: 10.62347/DBNQ6080. eCollection 2026.
PubMed 41877935
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of The Therapeutic Benefits of Nigella Sativa in Children With Beta Thalassemia Major
- ClinicalTrials.gov ID
- NCT02816957
- Acronym / sponsor ID
- Nigella / 30794l03l16
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 29 Jun 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 Nigella sativa in children with beta thalassemia major.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients receiving Nigella | Active comparator | Drug: nigella sativ40 patients in the treatment group that will receive nigella sativa powder (2 gm/day) for 3 consecutive months. |
| patients not received nigella as controls | No intervention | –40 patients in the control group will not receive nigella sativa and continued on the usual chelators |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Thalassemia with iron overload
Key exclusion criteria (2 listed)
- Thalassemia complicated with diabetes mellitus or hepatitis
- Patients who discontinue treatment
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 |
|---|---|---|
| nigella sativnigella sativa powder (2 gm/day) for 3 consecutive months. | Drug | patients receiving Nigella |
Primary outcome
malondialdehyde
Time frame: 3 months
nmol serum level of malondialdehyde (nmol per liter)
cluster of differentation4 and 8(CD4 and CD8)
Time frame: 3 months
CD4 and CD8 cell per cmm
total antioxidant
Time frame: 3 months
total antioxidant(mmol per liter)
4 secondary outcomes
Serum iron
Time frame: 3 months
total iron binding capacity
Time frame: 3 months
serum ferritin
Time frame: 3 months
complete blood count
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 26 Apr 2017.
- Derived from this study: PubMed 41877935Abdelshafy M, El Shanshory M, Shahat K, Al Jaouni SK, Attia M, Hamous SAA, Aboonq MS, Saad AA, Alayoubi AM, Bahashwan AS, Alhussaini AMT, Abdel-Latif HM, Albeihany AM, Hemdan SB, Yousef RS, Aloufi HA, Alsaedi AM, Alsaedi K, Eid RM, Mohamed N, Abdellah WA, Afifi TM, El Sayed SM, Hablas N. Immunological, hematological and biochemical benefits of adjuvant nigella sativa to pharmacotherapy in immune thrombocytopenic purpura patients. Am J Blood Res. 2026 Feb 15;16(1):1-13. doi: 10.62347/DBNQ6080. eCollection 2026.
- 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 Ramadan ELshanshory, prof study director
professor of pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing nigella sativ in people with Nigella Sativa With Beta Thalassemia Major, run by Tanta University at 1 site 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 2 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 26 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 1 site 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Mohamed Habas, MD (01010560350, nahedhablas79@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
malondialdehyde (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02816957, which also lists 1 linked publication.
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 26 Apr 2017.