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IRCT20220302054170N1 IRCT 2022-03-13 Shahid Beheshti University of Medical Sciences investigating the effect of Viola tablet on breast cancer-related fatigue investigating the effect of Viola odorata L. tablet on breast cancer-related fatigue: Pilot study 2022-04-21 anticipated 20 Complete https://irct.ir/trial/62335 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A table of random numbers will be created by rand Excel software. Before starting, we will determined the direction of selecting random numbers (for example from top to bottom). A series of random numbers will be selected from the table, and even numbers will be assigned to the control group and odd numbers to the intervention group. The codes will be then written on drug labels and kept secretly in an envelope. Containers containing coded drugs and placebo will be provided to the physician and research assistant. Patients start receiving from the smallest number of container to enter the plan. The first patient will be entered into the research will receive the intervention related to smallest code, and the last patient will receive the biggest code. Randomization unit: individual Randomization tool: Random number table, Blinding description: The tablets code will be written to the file. The physician, assistant, and patient will not be aware of any tablet content. (double-blind). 2 breast cancer. Intervention 1: The aqueous extract is prepared by boiling for 10 minutes using water in a ratio of 1:10. The extract prepared in the oven is dried at a temperature of 100 degrees and the resulting powder is used in the tablet formulation. To prepare the tablet, various types of medicinal excipients are used and pre-formulation studies are performed on them. The number of tablets used by patients after the tablet formulation will be determined depending on the amount of extract in each tablet. Since the effective dose in the animal study was 100 mg / kg and considering the formula: Equivalent human dose (mg / kg) = animal dose (mg / kg) × 0.162, the amount of extract for each person 60 kg was 972 mg. Per day is a dry extract of violet. Depending on the final formulation, there will be either two tablets per day (each containing 486 mg of extract) or three tablets per day (each containing 324 mg of extract). Intervention 2: Control group: The placebo will be made to look exactly like the original drug using the tablet's excipients. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Homa Hajimehdipoor
No.8, shams Ali, Valiasr Ave.
Tehran Iran (Islamic Republic of) 1516745811 +98 21 8877 6168 hajimehd@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Homa Hajimehdipoor
No.8, shams Ali, Valiasr Ave.
Tehran Iran (Islamic Republic of) 1516745811 +98 21 8877 6168 hajimehd@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Women aged 18 to 70 years old Suffering from breast cancer During radiotherapy Hemoglobin at least 8 g / dl Hematocrit at least 30% SGOT level less than 3 times the upper limit of normal Bilirubin less than 2mg / dl Creatinine less than 2mg / dl normal TSH 18 years 70 years Female Heart disease with unstable conditions Debilitating lung disease History of asthma History of allergies to Viola or any of the excipients in tablets Uncontrolled pain Severe infection Serious accompanying disease D05.9 Unspecified type of carcinoma in situ of breast Treatment - Drugs Placebo The aqueous extract is prepared by boiling for 10 minutes using water in a ratio of 1:10. The extract prepared in the oven is dried at a temperature of 100 degrees and the resulting powder is used in the tablet formulation. To prepare the tablet, various types of medicinal excipients are used and pre-formulation studies are performed on them. The number of tablets used by patients after the tablet formulation will be determined depending on the amount of extract in each tablet. Since the effective dose in the animal study was 100 mg / kg and considering the formula: Equivalent human dose (mg / kg) = animal dose (mg / kg) × 0.162, the amount of extract for each person 60 kg was 972 mg. Per day is a dry extract of violet. Depending on the final formulation, there will be either two tablets per day (each containing 486 mg of extract) or three tablets per day (each containing 324 mg of extract). Control group: The placebo will be made to look exactly like the original drug using the tablet's excipients. Visual Analogue Fatigue Scale. Timepoint: In weeks 0 and 4. Method of measurement: Questionnaire and Visual scale. Fatigue Severity Scale. Timepoint: In weeks 0 and 4. Method of measurement: Questionnaire and Visual scale. The Cancer Fatigue Scale. Timepoint: In weeks 0 and 4. Method of measurement: Questionnaire and Visual scale. Shahid Beheshti University of Medical Sciences Approved 2022-02-20 Vice-Chancellor in Research Affairs - Shahid Beheshti University of Medical Sciences 7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak Tehran Tehran Iran (Islamic Republic of)