Participants were randomly divided based on age, sex and severity of TBI in two groups. Randomization lists was computer-generated by a statistician and participants, project managers and employees at the clinic are completely unaware (blind) about intervention and control groups. At the first visit, baseline data were gathered and patients received EGCG supplement was in the form of 400 mg oral capsules with a purity of 80% catechin. EGCG powder of each capsule was dissolved in 10 ml deionized water and given to patients via gavage (1 capsule per day) for a week.

Placebo group only received 10 ml of deionized water via gavage for a week.

Traumatic Brain Injury

EGCG

Placebo (deionized water)

NNFTRI clinic

Effect of Epigallocatechin -3-gallate Supplementation in Traumatic Brain Injury Patients

Effect of Green Tea Epigallocatechin -3-gallate Supplementation on Traumatic Brain Injury Patients' Outcomes

Duration of mechanical ventilation is recorded by a nurse who is blinded to grouping and reported in days.

Dr Azita Hekmatdoost

Associate professor

National Nutrition and Food Technology Institute

Tehran University of Medical Sciences

Phase 1 (run-in): Marevan®
Phase 2: Marevan®
Phase 3: generic warfarin #1
Phase 4: generic warfarin #2

Phase 1 (run-in): generic warfarin #1
Phase 2: generic warfarin #1
Phase 3: Marevan®
Phase 4: generic warfarin #2

Phase 1 (run-in): generic warfarin #1
Phase 2: generic warfarin #1
Phase 3: generic warfarin #2
Phase 4: Marevan®

Phase 1 (run-in): Marevan®
Phase 2: Marevan®
Phase 3: generic warfarin #2
Phase 4: generic warfarin #1

Phase 1 (run-in): generic warfarin #2
Phase 2: generic warfarin #2
Phase 3: Marevan®
Phase 4: generic warfarin #1

Phase 1 (run-in): generic warfarin #2
Phase 2: generic warfarin #2
Phase 3: generic warfarin #1
Phase 4: Marevan®

Atrial Fibrillation

Branded warfarin sodium tablets (manufacturer União Química Farmacêutica Nacional S/A, Brazil) by mouth; dose adjusted according to INR and medical judgement.

Marevan®

Generic warfarin sodium tablets, manufacturer (União Química Farmacêutica Nacional S/A, Brazil), by mouth; dose adjusted according to INR and medical judgement.

generic warfarin #1

Generic warfarin sodium tablets, manufacturer (Laboratório Teuto Brasileiro S/A, Brazil), by mouth; dose adjusted according to INR and medical judgement.

generic warfarin #2

Hospital São Paulo/Hospital Universitário da UNIFESP (University Hospital of UNIFESP)

Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil

Therapeutic Equivalence Between Branded and Generic Warfarin Sodium Tablets in Adult Patients With Atrial Fibrillation in Brazil - Crossover Randomized Controlled Equivalence Trial

INR: International normalized ratio. INR will be assessed twice a month during the 16 weeks of study.
Delta INR will be calculated by the difference, in absolute numbers (i.e. in module), between the two valid INR measurements due for each patient with each formulation at each period. Difference between the delta INRs will be the outcome. We will compare generic to branded warfarin (Marevan®) and the generic formulations to each other.

INR: International normalized ratio. INR will be assessed twice a month during the 16 weeks of study.
We will calculate the mean INR for each formulation of warfarin; difference between the mean INRs will be the outcome. We will compare generic to branded warfarin (Marevan®) and the generic formulations to each other.

The warfarin dosage will be calculated as the sum of the dosage taken in the week before the study visit, as referred by the patient. We will calculate the mean dosage for each formulation of warfarin; difference between the mean dosage will be the outcome.
We will compare generic to branded warfarin (Marevan®) and the generic formulations to each other.

Includes ischemic stroke (differential diagnosis with hemorrhagic stroke by tomography) and thromboembolism of viscera or extremities (diagnosed by acute symptoms and relevant diagnostic tests).

Classified as major or minor bleeding events.
Major: intracranial hemorrhage, fatal bleeding, bleeding resulting in hemoglobin loss equal to or greater than 2.0 g / L, hemorrhage requiring transfusion, bleeding in sensitive areas such as the retina or pericardium.
Minor: all other bleeding.

TTR calculated by Rosendaal Method also known as linear interpolation method. We will calculate the mean TTR for each formulation of warfarin; difference between the mean TTRs will be the outcome.
We will compare generic to branded warfarin (Marevan®) and the generic formulations to each other.

Carolina Gomes Freitas

Graduate student (PhD)

Federal University of São Paulo

Fundação de Amparo à Pesquisa do Estado de São Paulo

40 subjects will receive 800 mg EGCG orally per day for 6 months versus 40 subjects will receive Brown Rice pill for 6 months

40 subjects will receive 800 mg brown rice pills orally per day for 6 months versus 40 subjects will receive EGCG capsule for 6 months

Leiomyoma

A randomized double-blind placebo-controlled clinical trial will be conducted with 80 women of reproductive age,the 80 women will be allocated into two groups, 40 each. Each group will be given one of two interventions: The first is 2 capsules of (EGCG which is green tea extract, taken orally with food on daily basis for 6 months, each capsule contain 326.25 mg decaffeinated EGCG,The second group will receive matched (color, taste and texture) placebo for a period of 6 months.

EGCG ( Green Tea extract)

40 subjects will receive 800 mg EGCG orally daily for 6 months, the other 40 subject will receive brown rice pills for the same duration.

camellia sinensis/hemorrhage

Effect of Epigallocatechin -3-gallate Supplementation in Traumatic Brain Injury Patients

Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil

Green Tea Extract: a Non-Surgical Alternative for Treatment of Uterine Fibroids

Effect of Mouthwash Containing Camellia Sinensis Extracts on Oral Malodor

Kõige täiuslikum ravimtaimede andmebaas, mida toetab teadus