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IRCT20190107042275N1 IRCT 2019-10-24 Shahid Beheshti University of Medical Sciences Effects of mixture of Distillated of Chicory and Fumitory on hot flash Effects of mixture of Distillated of Chicory and Fumitory compared with Venlafaxin on hot flashes in women with breast cancer 2019-11-01 anticipated 74 Complete https://irct.ir/trial/37099 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random sampling is performed by randomizer software on patients with inclusion criteria. The computer consists of numbers from zero to one if the random number is below 0.500 in the first group (distillated recipient) and if the number is above 0.500 enters in second group(Venlafaxin tablet recipient). 2-3 Breast Cancer. Intervention 1: Intervention group1: Mixture of distillated of Chicory and Fumitory, obtained by steam distillation of chicory and fumitory leaves at Institute of Medicinal Plants of Shahid Beheshti University, 75 ml in the morning and 75 ml in the night untill the end of the fourth weeks of intervention. Intervention 2: Intervention group 2: Venlafaxine tablets of Abidi pharmacology 37.5 mg dialy for the first week and from the second week 75 mg venlafaxine tablets until the end of the fourth week of intervention. Yes - There is a plan to make this available What will be shared: Publishing results in form of a PhD thesis and an article indexing in ISI When: َAfter PhD thesis defence To whom: Public Conditions: For research reasons Where to obtain: Shahid Beheshti University of Medical Sciences How to obtain: Approving by responsible officer Comments:
public Sina Moghtadaei
No 8, Shams Alley, Across from Shaid Abbaspour St, Vali Asr Ave
Tehran Iran (Islamic Republic of) 1516745811 +98 21 8877 3522 Sinamoghtadaei@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Sina Moghtadaei
No.8, Shams Alley, Across from Shaid Abbaspour St, Vali Asr Ave., Tehran
Tehran Iran (Islamic Republic of) 1516745811 +98 21 8877 3522 sinamoghtadaei@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Women between 18 and 65 years Breast cancer (stage 0-3) Having at least two hot flashes in 24 hours At least 4 weeks have elapsed since treatment with estrogen suppressive hormone therapy (Tamoxifen, LHRH agonists, Aromatase inhibitors) and continued unchanged until the end of the intervention. 18 years 65 years Female Lack of informed consent to the plan Life expectancy is less than 6 months Having another cancer at the same time as breast cancer The patient is undergoing chemotherapy, radiotherapy or surgery Use of acupuncture and complementary medicine (hypnosis, psychotherapy) Taking antidepressants in the last 4 weeks Use of Anxiolytic drug, Gabapentin, Pregablin, Clonidine, Aspirin, Vitamin E, Omega 3, Phytoestrogenic supplements and high phytoestrogenic diet Drug allergy to venlafaxine Allergy to distillated of Chicory and Fumitory kidney test (BUN,CR) is not in normal laboratory range Liver enzymes AST and ALT are more than twice the normal laboratory range and Total Billirubin ≥2 C50 Malignant neoplasm of breast Treatment - Drugs Treatment - Drugs Intervention group1: Mixture of distillated of Chicory and Fumitory, obtained by steam distillation of chicory and fumitory leaves at Institute of Medicinal Plants of Shahid Beheshti University, 75 ml in the morning and 75 ml in the night untill the end of the fourth weeks of intervention. Intervention group 2: Venlafaxine tablets of Abidi pharmacology 37.5 mg dialy for the first week and from the second week 75 mg venlafaxine tablets until the end of the fourth week of intervention. Number of hot flashes: average of frequency during a week according to based on Daily Hot flashes Diary. Timepoint: Daily. Method of measurement: Daily Hot flashes ِDiary which is filled daily by the patient. Severity of hot flashes: average of severity during a week according to based on Daily Hot flashes Diary. Timepoint: Daily. Method of measurement: Each hot flashes is recorded by the patient on a daily hot flashes diary record at 4 degrees of mild, moderate, severe, and very severe. Shahid Beheshti University of Medical Sciences Approved 2019-01-06 Ethic committee of Shahid Beheshti University of Medical Sciences 3th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak Tehran Tehran Iran (Islamic Republic of)