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IRCT20180722040556N1 IRCT 2019-05-28 Esfahan University of Medical Sciences Trigonella, Foeniculum, Chichorium, Hornleum and Glycine in prevention of cancer-induced cachexia/anorexia Evaluation of herbal combination consists of Trigonella, Foeniculum, Chichorium, Hornleum and Glycine in the prevention of cancer-induced cachexia/anorexia of solid tumors’ patients: a randomized, double-blinded, placebo-controlled clinical trial 2018-07-26 anticipated 60 Complete https://irct.ir/trial/33797 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, the randomization will be carried out according to simple randomization via the random numbers obtained by Excell software, Blinding description: In this study, we will use the doubled-blinded randomization in which both investigator and included patients will be blinded. 2 Cancer-induced cachexia. Intervention group: Herbal combination including Trigonella, Foeniculum, Chichorium, Hornleum, and Glycine provided in Dineh company named General Tonic, one sachet three times a day for four 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
Daneshgah street
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 tumor malignancies (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. Cancer patients with serum total bilirubin < 2 mg / dl. Patients haven't had any sign of dysphagia or gastrointestinal obstruction. We have expected patients to be alive at least 3 upcoming months. Patients who have received high doses of megestrol due to cachexia and anorexia simultaneously. 18 years 80 years Both Patients who have undergone major surgery for 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 have consumed chronic alcohol. Patients who are pregnant or breast-feeding. Patients with a known hypersensitivity reaction to one of the plants in considered herbal combination C80.9 C80.0 Treatment - Drugs Intervention group: Herbal combination including Trigonella, Foeniculum, Chichorium, Hornleum, and Glycine provided in Dineh company named General Tonic, one sachet three times a day for four weeks Evaluation of herbal combination consists of Trigonella, Foeniculum, Chichorium, Hornleum, and Glycine in the prevention of cancer-induced cachexia/anorexia. Timepoint: Baseline and 4 weeks later. Method of measurement: Edmonton criteria. Quality of life. Timepoint: Baseline and four weeks later. Method of measurement: Iranian Version of the EORTC QLQ. Esfahan University of Medical Sciences Approved 2018-11-11 Ethics committee of Isfahan University of Medical Sciences Daneshgah street Isfahan Isfehan Iran (Islamic Republic of)