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IRCT20191211045693N1 IRCT 2022-08-20 Shahid Beheshti University of Medical Sciences Effects of “compound Ma-ol-asal" syrup on cancer-related fatigue Effects of “compound Ma-ol-asal" syrup on cancer-related fatigue in gastrointestinal (GI) cancer patients who are undergoing chemotherapy 2022-07-23 anticipated 120 Complete https://irct.ir/trial/63912 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the restricted randomization method of block randomization is used. Blocking is used to balance the number of samples assigned to each of the study groups. The randomization method was performed using balanced block randomization and in the form of 4 blocks using the computer. Each drug is labeled with a number from 1 to 120. Patients were divided into two groups for the trial: the first group (60 people) was the intervention group and the second (60 people) was the control group (placebo group). Both groups were equally divided in terms of characteristics and coordinated conditions. The control group is assigned to "A" and the intervention group to "B", and then these two groups are divided into 6 blocks of 4: (1) AABB, (2) BBAA, (3) ABAB, (4) BABA, (5) AB BA, (6) BAAB . These blocks are randomly stacked together by a computer to form a chain of random groups (e.g. B B A A A A B B A B A B B A B A A B B A B A A B ) Patients then enter these groups in the order of enrollment. For randomization, a randomization tool for random sequence software called Random allocation software is used. In addition to simple randomization, this software is also able to generate random sequences by the block generation method. For concealment, we use allocation concealment, which is the method used to execute a random sequence on the study participants, so that the assigned group is not known before the individual is assigned. Jollab or placebo bottles are produced with the same shape and color and after coding with a random sequence, each of the random sequences created is recorded on a label. The labels are stuck on Jollab or placebo bottles. Participants will receive the labeled bottles, Blinding description: In this study, both Jollab syrup and placebo are made by the pharmacist in the laboratory and dumped and coded in similar bottles that only the pharmacist knows about the codes and in the same way it will be given to researchers and basis on randomization finally for participants both so the researcher and the participant are blinded. 3 Neoplastic (malignant) related fatigue. Intervention 1: Intervention group:In addition to all the standard and required medicines, patients with GI cancer-related fatigue receiving “compound Ma-ol-asal" syrup that is made by Niak Pharmaceutical Company, 10 cc three times daily for four weeks;. Intervention 2: Control group: In addition to all the standard and required medicines, patients with GI cancer-related fatigue receiving placebo that is made by Niak pharmaceutical company , 10 cc three times daily for four weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is The study has not started yet, and the progress of the work and the data cannot be predicted so a decision will be made after the completion of the project.
public Ata Amani
No8, Shams Alley, In front of Tavanir Ave., Vali-Asr Ave., Faculty of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Tehran Iran (Islamic Republic of) 1516745811 +98 21 8877 3521 dr-amani@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Dr. Ghazaleh Heydarirad
No8, Shams Alley, In front of Tavanir Ave., Vali-Asr Ave., Faculty of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Tehran Iran (Islamic Republic of) 1516745811 +98 21 8877 6027 ghazalrad@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 1.Age between 18- 70 years old 2. GI cancer (pathologically diagnosed) 3.Undergoing chemotherapy 4. Hemoglobin level at least 10g/dl 5. Hematocrit level at least 30% . 6. No clinical symptom of hypothyroidism 7. Visual Analogue Fatigue Scale (VAS)>=4 18 years 78 years Both 1. Heart disease with unstable conditions 2. Liver disease with unstable conditions 3. Disabling pulmonary disease 4. Positive history of hypersensitivity to honey and its compounds 5. Positive history of hypersensitivity to each component of the “compound Ma-ol-asal" syrup. 6. Uncontrolled pain. 7. An individual who uses treatment due to known psychiatric disease 8.Pregnancy. 9. Simultaneous use of drugs that affect fatigue. 10. kidney disease with unstable conditions 11. Severe infection 12. Serious accompanying disease. R53.0 Neoplastic (malignant) related fatigue Treatment - Drugs Placebo Intervention group:In addition to all the standard and required medicines, patients with GI cancer-related fatigue receiving “compound Ma-ol-asal" syrup that is made by Niak Pharmaceutical Company, 10 cc three times daily for four weeks; Control group: In addition to all the standard and required medicines, patients with GI cancer-related fatigue receiving placebo that is made by Niak pharmaceutical company , 10 cc three times daily for four weeks. Score of Fatigue Severity "Visual Analogue Fatigue Scale". Timepoint: Week 0 (before the start of the intervention) and week 4 (after the start of the intervention). Method of measurement: Using Visual Analogue Fatigue Scale questionnaire. Score of "The Cancer Fatigue Scale". Timepoint: The weeks of 0 and 4 after treatment. Method of measurement: The Cancer Fatigue Scale questionnaire. Dyspepsia. Timepoint: Week 0 (before the start of the intervention) and week 4 (after the start of the intervention). Method of measurement: Likert scale. Shahid Beheshti University of Medical Sciences Approved 2020-06-07 Ethics Committee of Shahid Beheshti University of Medical Sciences Velenjak, Yaman Ave., Sh. Aarabi Ave., Shahid Beheshti University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)