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IRCT20180722040556N2 IRCT 2019-10-06 Esfahan University of Medical Sciences Trigonella, Foeniculum, Chichorium in prevention of cancer-induced cachexia/anorexia Evaluation of the herbal combination of Cichorium inyubus, Trigonella foenum-graecum and Foeniculum vulgare in the prevention of cancer-induced cachexia/anorexia in solid tumours’ patients: a randomized, double-blinded, placebo-controlled clinical trial 2018-07-26 anticipated 60 Complete https://irct.ir/trial/33796 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of sampling is based on Blocked randomization. In this method, the information about the number of treatment group, block size (multiples of group number) and the whole number of patients will be entered into internet software ( https://www.sealedenvelop.com) and according to obtained codes, the type of drugs for each patient will be determined. In this study, the number of treatment groups will be 2 groups and we will use 4-containing blocks. The predicted patients' sample size will be allocated randomly according to patients' order of recruitment and special code allocation into two groups of placebo and intervention, Blinding description: In this study, we will use the doubled-blinded randomization in which both investigator and patients will be blinded. The main investigator will allocate the concealed code to the herbal tablet or placebo according to random numbers and will provide them to investigators in charge of sampling. The investigators who are in charge of sampling will be given the herbal tablet or placebo to the patients numerically and in a blind way. 3 Cancer-induced cachexia. Intervention 1: Intervention group: Herbal combination including Trigonella, Foeniculum, Chichorin provided in Dineh company named Chicoridine, one tablet three times a day for eight weeks. Intervention 2: Control group: Placebo in the form of the tablet without any effective herbal combination provided in Dineh company identical to intervention group tablets, one tablet three times a day for eight weeks. Yes - There is a plan to make this available What will be shared: All data can be shared When: Starting 6 months after publication To whom: People working in academic institutions Conditions: All required analyses can be applied Where to obtain: Azadeh Moghaddas, Clinical Pharmacy Department, School of Pharmacy, Isfahan University of Medical Sciences, Hezarjarib street, Isfahan. moghaddas@pharm.mui.ac.ir How to obtain: After sending a request, we will call the related person and the data will be revealed in less than one week. Comments:
public Azadeh Moghaddas
Isfahan University of medical Scienices, Daneshgah street, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7074 azadeh_moghaddas@yahoo.com Esfahan University of Medical Sciences scientific Azadeh Moghaddas
Isfahan University of medical Scienices, Daneshgah street, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7074 azadeh_moghaddas@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) All adult patients (18 years and older) with advanced solid malignant tumour (Stage 3-4) who encountered cancer-induced anorexia or weight loss (equal or greater than 5% of the previous weight before cancer diagnosis or within the last two months). Cancer patients with serum creatinine < 2 mg /dl and serum total bilirubin < 2 mg /dl. Patients should not have any sign of dysphagia or gastrointestinal obstruction. The patients' life expectancy should be at least 3 months. Patients who are taking high doses of megestrol due to cachexia and anorexia simultaneously. 18 years 80 years Both Patients who have undergone major surgery during the last 4 weeks. Patients with a history of thrombophlebitis diseases. Patients who have been taking systemic corticosteroid within the last 4 weeks or concurrently. Patients who have cognitive impairment, psychiatric disorder or brain metastasis leading to cognitive impairment. Patients who have diabetes, uncontrolled blood pressure or advanced heart failure (NYHA 4) Patients who are alcoholic. Patients who are pregnant or breast-feeding. Patients with a known hypersensitivity reaction to one of the plants in study herbal combination. C80 Malignant neoplasm without specification of site Treatment - Drugs Placebo Intervention group: Herbal combination including Trigonella, Foeniculum, Chichorin provided in Dineh company named Chicoridine, one tablet three times a day for eight weeks Control group: Placebo in the form of the tablet without any effective herbal combination provided in Dineh company identical to intervention group tablets, one tablet three times a day for eight weeks Cachexia/anorexia. Timepoint: Baseline and 8 weeks later. Method of measurement: Edmonton criteria. Quality of life. Timepoint: Baseline and eight weeks later. Method of measurement: Iranian Version of the EORTC QLQ. Esfahan University of Medical Sciences Approved 2019-05-15 Ethics committee of Isfahan University of Medical Sciences Isfahan University of medical Scienices, Daneshgah street, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)