]>
IRCT20171118037516N1 IRCT 2018-03-06 Mazandaran University of Medical Sciences Evaluation the effectiveness of pomegranate and spearmint (Vomigramint) syrup on CINV Evaluation the effectiveness of a mixture-syrup based on pomegranate and spearmint (Vomigramint), compared with placebo, on Chemotherapy induced nausea and vomiting (CINV) in breast cancer 2018-02-19 anticipated 60 Complete https://irct.ir/trial/28173 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients are randomly divided into two groups by using Block randomization method. Personalized randomization method is done by using random allocation software. Samples divided in ten blocks and six rows. Selection of random digits for blocks is done by random allocation software table tool. Drug and placebo are prepared for patients with similar specificity and different 4 digit numbers, assigned by statics expert e. Researcher and patients do not know about drug or placebo, Blinding description: Random allocation and blinding was done this way: In the absence of research team, The statics expert of Mazandaran university of medical sciences, by using a computerized random allocation software table tool, blindly allocated patients into intervention or control groups. Hereafter, drug package with 4- digit codes were determined for patients by research fellow. Thus, this study is a randomized and double-blind. 3 Condition 1: nausea and vomiting. Condition 2: Breast cancer. Intervention 1: Intervention group: 30 patients with breast cancer, using syrup (250 cc bottle) contains of pomegranate juice and spearmint extract (with proportion of 2/1), produced with Persian medicine formulation, drinking three times per day and each time 10cc of syrup, pre-prandial, for 8 days (3 days before to 5 days after chemotherapy course, except the day of chemotherapy infusion). Intervention 2: Control group: 30 patients with breast cancer, using syrup ( 250 cc bottle) contains of distilled water and eatable caramel, with similar specifications to drug (as color, taste, density and volume), drinking three times per day and each time 10cc of syrup, pre-prandialŲŒ for 8 days (3 days before to 5 days after chemotherapy course, except the day of chemotherapy infusion). 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 No more information
public Seyede Sedighe Yousefi
Faculty of medical sciences, Payambar aazam university complex, Khazar abad broad- way, Sari city, Mazandaran province, Iran
Sari Iran (Islamic Republic of) 48471-91971 +98 11335430813 s.yousefi@mazums.ac.ir Mazandaran University of Medical Sciences scientific Seyede Sedighe Yousefi
Faculty of medical sciences, Payambar aazam university compex, Khzar abad broad way, Sari city, Mazandaran province, Iran
Sari Iran (Islamic Republic of) 48471-91971 +98 11335430813 s.yousefi@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) More than 18 years-old aging Documentary report for Breast cancer At least one session of chemotherapy is done prior to intervention Taking similar and one-day chemotherapy regimen At least two sessions of chemotherapy is proceeding History of any level of CINV (qualitative or quantative), despite taking routine anti-emetic drugs. 18 years no limit Female Total or upper abdomen radiotherapy, accompanying with chemotherapy simultaneously Consumption therapeutic dosage of anti-coagulant agents History of coagulopathic disorders Taking anti- emetic drugs or methods, except those permitted drugs in this study History of hypersensitivity to pomegranate or spearmint Pomegranate or spearmint consumption during one week prior to intervention Suffering from other cancers or metastatic breast cancer simultaneously Having other problems or diseases causing nausea( e.g. Hypertension, Liver or Renal failure, Diabetes mellitous , Constipation ) R11 C50.9 Nausea and vomiting Malignant neoplasm of breast of unspecified site, female Treatment - Drugs Placebo Intervention group: 30 patients with breast cancer, using syrup (250 cc bottle) contains of pomegranate juice and spearmint extract (with proportion of 2/1), produced with Persian medicine formulation, drinking three times per day and each time 10cc of syrup, pre-prandial, for 8 days (3 days before to 5 days after chemotherapy course, except the day of chemotherapy infusion). Control group: 30 patients with breast cancer, using syrup ( 250 cc bottle) contains of distilled water and eatable caramel, with similar specifications to drug (as color, taste, density and volume), drinking three times per day and each time 10cc of syrup, pre-prandialŲŒ for 8 days (3 days before to 5 days after chemotherapy course, except the day of chemotherapy infusion). Severity of nausea. Timepoint: Three days before intervention, One day after intervention, five days after intervention. Method of measurement: Visual analogue scale. Mazandaran University of Medical Sciences Approved 2018-01-13 Ethics committee, Mazandaran University of Medical Sciences Research and technology center of mazandaran university of medical sciences, Moallem square, Moallem avenue, Sari, Mazandaran, Iran Sari Mazandaran Iran (Islamic Republic of)