The infusion of chamomile will be prepared in the clinic with 400 mL of distilled water and 10 g of chamomile flowers (Chamomile classic infusion, Royal Herbs).
Ice cubes will be prepared in special ice trays placed in the chemotherapy center for this purpose.
Patient will receive a cup of ice cubes which is continuously replenished before being emptied.
Patients will be instructed to swish the ice cubes around their oral cavities starting 5 minutes before chemotherapy infusion, continuing 30 minutes throughout the session and for additional 35 minutes after completion of intravenous chemotherapy session.

The plain icecubes will be prepared in the clinic with 400 mL of distilled water.
Ice cubes will be prepared in special ice trays placed in the chemotherapy center for this purpose.
Patient will receive a cup of ice cubes which is continuously replenished before being emptied.
Patients will be instructed to swish the ice cubes around their oral cavities starting 5 minutes before chemotherapy infusion, continuing 30 minutes throughout the session and for additional 35 minutes after completion of intravenous chemotherapy session.

Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy

The infusion of chamomile will be prepared in the clinic with 400 mL of distilled water and 10 g of chamomile flowers (Chamomile classic infusion, Royal Herbs). Patients are asked to swish the chamomile ice cubes around their oral cavities starting 5 minutes before chemotherapy infusion, continuing 30 minutes throughout the session and for additional 35 minutes after completion of intravenous chemotherapy session.

Chamomile oral cryotherapy

The plain icecubes will be prepared in the clinic with 400 mL of distilled water. Patients are asked to swish the ice cubes around their oral cavities starting 5 minutes before chemotherapy infusion, continuing 30 minutes throughout the session and for additional 35 minutes after completion of intravenous chemotherapy session.

Oral cryotherapy

National Cancer Institute

Prevention of Oral Mucositis After Using Chamomile Oral Cryotherapy Versus Oral Cryotherapy in Pediatric Cancer Patients Receiving Chemotherapy.

Prevention of Oral Mucositis After Using Chamomile Oral Cryotherapy Versus Oral Cryotherapy in Pediatric Cancer Patients Receiving Chemotherapy: (A Randomized Pilot Study)

Primary outcome is measured using Children International Mucostitis Evaluation Scale (CHIMES).ChIMES1-4 each received a score of 0-5 where 5 is the worst degree of symptoms. ChIMES5 and ChIMES6 received a score of 1 or 0 if the child had received pain medications or not. Finally, ChIMES7 received a score of 1or 0 if oral ulcers were present or not. Any question that was scored as missing or 'I can't tell' was excluded from the total possible score. If all the questions were answered, the maximum score was 23. The ChIMES Total Score was the sum of all scores; 'I can't tell' responses and missing responses both received a score of 0. The ChIMES Percentage Score was the ChIMES Total Score over the total maximum score taking into account 'I can't tell' responses (by subtracting these items from the maximum score) multiplied by 100. Higher values indicate a worse outcome.

Assessed using Oral Mucositis World Health Organization Toxicity Scale.It represents grades of oral mucositis ranging from 0-4 with higher grades indicating worse outcome.

Dina Yousef Abdel Aleem Essa

Master Degree Student

Cairo University

National Cancer Institute, Egypt

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

Colonic Diseases, Functional

CHT - herbal therapy

Hadassah Medical Organization

Combination Herbal Therapy (CHT) Versus Placebo in Patients With Irritable Bowel Syndrome (IBS)

A Phase I, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study to Evaluate the Safety and Efficacy of a Combination Herbal Therapy (CHT), Versus Placebo in Improving the Overall Quality of Life and Symptoms in Patients With Irritable Bowel Syndrome (IBS)

matricaria discoidea/antimykotikum

Prevention of Oral Mucositis After Using Chamomile Oral Cryotherapy Versus Oral Cryotherapy in Pediatric Cancer Patients Receiving Chemotherapy.

Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil

Combination Herbal Therapy (CHT) Versus Placebo in Patients With Irritable Bowel Syndrome (IBS)

Treatment of Functional Abdominal Pain in Children: Evaluation of Relaxation/Guided Imagery and Chamomile Tea as Therapeutic Modalities

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