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IRCT20221229056976N1 IRCT 2023-01-26 Mashhad University of Medical Sciences Evaluation of the effects of curcumin-piperine in reducing Pseudomonas infection and improving clinical outcome in patients with cystic fibrosis Evaluation of the effects of curcumin-piperine in reducing Pseudomonas infection and improving clinical outcome in patients with cystic fibrosis 2023-03-05 anticipated 138 Complete https://irct.ir/trial/67791 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The samples will be determined by random block method with blocks of 4 and using random numbers table of SAS software. Blocking and allocation sequence for concealment will be done by a person not involved in the research. The allocation ratio of the samples will be (Allocation 1:1) and will be placed in two groups (Assignment). Then, based on the obtained blocks and according to the allocation sequence, the drugs will be given to the patients, Blinding description: To blind the participants, a placebo will be used with packaging, color, size and other appearance characteristics completely similar to curcumin-piperine tablets. In order to blind the evaluators of the research team, as soon as the treatment or control group is determined in the randomization stage, a random code will be assigned to the participant (without including group A or B on the file) and they will be followed by this code in any stage of research. Finally, after evaluating and documenting the results ,the codes will be decoded. 3 cystic fibrosis. Intervention 1: Intervention group: the intervention group are cystic fibrosis patients with pseudomonas infection who are treated with curcumin-piperine in addition to the usual treatments for cystic fibrosis. The duration of the treatment period will be 3 months. Curcumin-piperine is prepared in the form of 500 mg capsules with 5 mg of piperine as an absorption enhancer (Sami Labs Ltd., India) and is given to cystic fibrosis patients along with the usual treatments. Intervention 2: Control group: The control group are patients with cystic fibrosis who are treated with placebo in addition to the usual treatments of cystic fibrosis. placebo tablets containing microcrystalline cellulose matched in size, shape and color to the curcuminoids tablets. 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 further information
public Saeedeh Talebi
Akbar Hospital,Kaveh Blvd, Region 9, Mashhad
Mashhad Iran (Islamic Republic of) ٩١٧٧٨٩٧١۵٧ +98 51 3871 3801 Talebis@mums.ac.ir Mashhad University of Medical Sciences scientific Saeedeh Talebi
Akbar Hospital,Kaveh Blvd, Region 9, Mashhad
Mashhad Iran (Islamic Republic of) ٩١٧٧٨٩٧١۵٧ +98 51 3871 3801 Talebis@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Cystic fibrosis patients who have been diagnosed based on clinical symptoms and sweat test. 5 years and above. Have pulmonary and gastrointestinal problems. able to perform the spirometry maneuver and have at least FEV1 greater than or equal to 30% based on the normal population based on age, gender and height. The percentage of oxygen saturation based on pulse oximetry should be greater than or equal to 90% at room temperature. be clinically stable. Informed consent has been obtained from the patients. Do not have heart, liver or kidney failure. Do not have celiac disease. No evidence of acute pulmonary exacerbation that requiring hospitalization in last past 4 weeks. Do not have evidence of severe complications of pulmonary disease including severe hemoptysis or pneumothorax during the last 2 months. 5 years no limit Both E84 Cystic fibrosis Treatment - Drugs Placebo Intervention group: the intervention group are cystic fibrosis patients with pseudomonas infection who are treated with curcumin-piperine in addition to the usual treatments for cystic fibrosis. The duration of the treatment period will be 3 months. Curcumin-piperine is prepared in the form of 500 mg capsules with 5 mg of piperine as an absorption enhancer (Sami Labs Ltd., India) and is given to cystic fibrosis patients along with the usual treatments. Control group: The control group are patients with cystic fibrosis who are treated with placebo in addition to the usual treatments of cystic fibrosis. placebo tablets containing microcrystalline cellulose matched in size, shape and color to the curcuminoids tablets Evaluation of clinical symptoms of patients. Timepoint: In each visit. Method of measurement: Based on Shwachman-Kulczycki Score. Evaluation of pulmonary symptoms. Timepoint: Every 3 to 6 months. Method of measurement: Based on spirometry. Evaluation of Pseudomonas pulmonary infection. Timepoint: Every 3 months. Method of measurement: With nasopharyngeal swab sample (sputum culture and colony count). Weight. Timepoint: In each visit. Method of measurement: Weighing scale. Height. Timepoint: In each visit. Method of measurement: Meter. Body mass index (BMI). Timepoint: In each visit. Method of measurement: Body weight (kg) divided by the square of the body height(m). Evaluation of patients' quality of life. Timepoint: Yearly. Method of measurement: Based on the quality of life questionnaire of cystic fibrosis patients. Mashhad University of Medical Sciences Approved 2022-11-08 Ethics committee of Mashhad University of Medical Sciences Shahid Fakouri Blvd, Mashhad, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)