Participants in group 1 will be given corticosteroid lotion (Betamethasone valerate 0.1%) and will be advised to apply it topically (0.5 ml) on the buccal mucosa thrice a day along with physiotherapy using ice cream sticks three times a day for the duration of 10 minutes (3-5minutes on each side).

Group 2 will be given commercially available, cold pressed N.sativa (Black seed) oil and will be advised to apply it topically over the buccal mucosa (1 ml) thrice a day along with physiotherapy using ice cream sticks three times a day for the duration of 10 minutes (3-5minutes on each side).

Oral Submucous Fibrosis

Using N.sativa oil as an alternative to conventional management will help us to find a treatment option which is non-invasive, cost effective, inexpensive, easy available and belongs to a natural source with almost no side effects.

Nigella sativa oil

it is a conventionally used drug for treating OSMF

Betamethasone Valerate

Comparative Effect of Nigella Sativa and Conventional Management for OSMF

Comparison of Nigella Sativa Oil With Conventional Management on Clinical Outcomes in Oral Submucous Fibrosis

Pain will be measured using VAS. This scale usually present as a 100-mm horizontal line on which the pain intensity experienced by the patient will be represented by a point between the extremes of "no pain at all" and "worst pain imaginable.

Interincisal mouth opening will be calculated by measuring the distance between the mesioincisal angles of the maxillary central incisor and the mandibular central incisor with the help of a vernier calliper.

A line will be drawn from the tragus of the ear to the angle of the mouth and then two reference points will be marked on both the cheeks at 1/3rd the distance from the angle of the mouth on the line drawn previously. After marking these reference points, the patient will be asked to blow his cheek and the distance will be measured between the two points. Then the patient will be instructed to relax his cheeks and the distance will be measured again. The difference between the two values will give the value for cheek flexibility.

Tongue protrusion will be recorded by measuring the distance between the tip of the tongue and the mesioincisal angle of the upper central incisor using steel ruler.

Hira Batool

Doctor

Ziauddin University

50 patients from each participating hospital that will receive Omega-3 supplementation (300-400mg EPA & 200-300mg DHA) per day for 8 consecutive months up to 10 months.
in addition to experimental treatment this group will receive the traditional treatment of deferoxamine/deferasirox plus regular blood transfusion with dose de-escalation methods till efficacy of experimental treatment proved.

50 patients from each participating hospital that will receive Nigella sativa supplementation (1g black seed oil contain 1% thymoquinone) per day for 8 consecutive months up to 10 months.
in addition to experimental treatment this group will receive the traditional treatment of deferoxamine/deferasirox plus regular blood transfusion with dose de-escalation methods till efficacy of experimental treatment proved.

50 patients from each participating hospital that will receive hydroxyurea medication (5 to 15mg/kg) per day for 8 consecutive months up to 10 months.
in addition to the experimental treatment, this group will receive the traditional treatment of deferoxamine/deferasirox plus regular blood transfusion with dose de-escalation methods until the efficacy of experimental treatment proved.

50 patients from each participating hospital that will receive natural honey(2.5 mg/kg dissolved in 250 ml water) per day for 8 consecutive months up to 10 months.
in addition to the experimental treatment, this group will receive the traditional treatment of deferoxamine/deferasirox plus regular blood transfusion with dose de-escalation methods until the efficacy of experimental treatment proved.

50 patients from each participating hospital that will receive the ordinary treatment of iron chelator agent of deferoxamine or deferasirox (SubQ infusion: 20 to 40 mg/kg/day over 8 to 12 hours, 6 to 7 nights per week, maximum daily dose: 40 mg/kg/day)for 8 consecutive months up to 10 months.
in addition to iron chelator agent, this group receive regular blood transfusion session.

Iron Overload

Oxidative Stress

Thalassemia Major

Omega-3 supplementation (300-400mg EPA & 200-300mg DHA) per day for 8 consecutive months up to 10 months

Omega 3

Nigella sativa supplementation (1g black seed oil contain 1% thymoquinone) per day for 8 consecutive months up to 10 months

Nigella Sativa Oil

hydroxyurea medication (5 to 15mg/kg) per day for 8 consecutive months up to 10 months.

Hydroxyurea

Natural honey(2.5 mg/kg dissolved in 250 ml water) per day for 8 consecutive months up to 10 months.

Honey

deferoxamine (SubQ infusion: 20 to 40 mg/kg/day over 8 to 12 hours, 6 to 7 nights per week, maximum daily dose: 40 mg/kg/day)for 8 consecutive months up to 10 months.

Deferoxamine

Regular blood transfusion session based on patient hematological profile starts from one session every 2 weeks.

blood transfusion session

Faculty of medicine, Beni-suef univeristy - Beni-Suef university hospital

Faculty of Pharmacy, Beni-Suef university

Health insurance hospital

Maternity and Children hospital

Hydroxy Urea, Omega 3, Nigella Sativa,Honey on Oxidative Stress and Iron Chelation in Pediatric Major Thalassemia

Impact of Combination Therapy Between Hydroxy Urea, Omega 3, Nigella Sativa and Honey on Antioxidant-oxidant Status and Reduction of Iron Overload in Pediatric Major Thalassemia

plasma F 2 -isoprostanes Picograms Per Millilitre measured by high pressure liquid chromatography assay

Total cholesterol milligrams per deciliter

Serum total iron micrograms per decilitre

C-reactive protein milligrams per deciliter

Total Iron Binding Capacity micrograms per decilitre

mean corpuscular hemoglobin (MCH) Picograms Per Millilitre

Chelation activity of Ferric - thymoquinone complex in percentage measured by high pressure liquid chromatography coupled with gaschromatography - mass spectroscopy analysis

Chelation activity of Ferrous - thymoquinone complex in percentage measured by high pressure liquid chromatography coupled with gaschromatography- mass spectroscopy analysis

Lactic acid dehydrogenase unit per litter

hemoglobin- F level in gram per deciliter

Reticulocyte absolute count in a cubic milliliter of blood

White blood cells count in a cubic milliliter of blood

Mohamed Medhat Abdelwahab Gamaleldin

Dr.Mohamed Medhat Abdelwahab Gamaleldin

Beni-Suef University

Maternity and Children Hospital, Makkah

Department of clinical pharmacy, faculty of pharmacy, Beni-suef univeristy

Beni-Suef Health insurance hospital

University of Arizona

College of Pharmacy,Department of Pharmacy Practice,University of Arizona

Four experimental groups, one control group.
Each experimental group receives different experimental treatments plus traditional treatment in the hospital and the control group receives only traditional treatment.

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

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

Nigella Sativa With Beta Thalassemia Major

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

nigella sativ

Faculty of Medicine- Tanta University

Benefits of Nigella Sativa in Children With Beta Thalassemia Major

Study of The Therapeutic Benefits of Nigella Sativa in Children With Beta Thalassemia Major

nmol serum level of malondialdehyde (nmol per liter)

Tanta University

Vitamin E (200 mg, soft capsule) plus Nigella sativa (500 mg, soft capsule) twice daily, orally for 12 weeks

Vitamin E (200 mg, soft capsule) plus Placebo (refined oil in soft capsule with same size and color as that contains N sativa) twice daily, orally for 12 weeks

Arsenical Keratosis

Vitamin E

Nigella sativa

Placebo (refined oil in soft capsule with same color and size like that contains N. sativa)

Placebo

Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University

Effect of Nigella Sativa in the Treatment of Palmer Arsenical Keratosis

A Double-blind, Randomized, Placebo-controlled Trial of Nigella Sativa in the Treatment of Palmer Arsenical Keratosis

Signs and symptoms of palmer arsenical keratosis will be examined by one trained doctor at the temporary arsenic camp at regular interval (2 weeks). Another doctor will note the findings of the patient in the data collection sheet without informing the previous data to the former doctor.
Signs and symptoms of moderate arsenical keratosis will be assessed by estimating the number and size of keratotic lesions and expressed into scoring.

Amount of arsenic in nails will be estimated by Atomic Fluorescence spectrometry (AFS) both before and after completion of treatment.

To see any change in the concentration of plasma vitamin E levels after use of N.sativa capsules. This parameter will be estimated by spectrophotometric method.

To see any change in the concentration of serum cholesterol levels after use of N. sativa. This parameter will be estimated by spectrophotometric method.

To see any change in the concentration of serum bilirubin, transaminase levels after use of N. sativa. These parameters will be estimated by spectrophotometric method.

To see any change in the concentration of blood urea and serum creatinine levels after use of N. sativa. These parameters will be estimated by spectrophotometric method.

nigella/antioxidant

Comparative Effect of Nigella Sativa and Conventional Management for OSMF

Hydroxy Urea, Omega 3, Nigella Sativa,Honey on Oxidative Stress and Iron Chelation in Pediatric Major Thalassemia

Benefits of Nigella Sativa in Children With Beta Thalassemia Major

Effect of Nigella Sativa in the Treatment of Palmer Arsenical Keratosis

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