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IRCT20210226050506N1 IRCT 2021-06-09 Shahid Beheshti University of Medical Sciences Effects of Chicory and Fumitory products on hot flashes Effects of Chicory and Fumitory products on hot flashes in breast cancer patients 2021-05-05 anticipated 64 Complete https://irct.ir/trial/54610 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study the restricted Randomization method of block randomization is used. Blocking is used to balance the number of samples assigned to each of the study groups. Randomization method was performed using balanced block randomization and in the form of 4 blocks using computer. Each drug is labeled with a number from 1 to 64. Patients were divided into two groups for the trial: the first group (32 people) intervention group or drug group and the second control group (32 people) placebo group. Both groups were equally divided in terms of characteristics and coordinated conditions. The control group is assigned to "A" and the intervention group to "B", and then these two groups are divided into 6 blocks of 4: (1) AABB, (2) BBAA, (3) ABAB, (4) BABA, (5) AB BA, (6) BAAB .These blocks are randomly stacked together by a computer to form a chain of random groups (e.g. B B A A A A B B A B A B B A B A A B B A B A A B ) Patients then enter these groups in the order of enrollment. For randomization, a randomization tool for random sequence software called Random allocation software is used. In addition to simple randomization, this software is also able to generate random sequences by block generation method. For concealment, we use allocation concealment, which is the method used to execute a random sequence on the study participants, so that the assigned group is not known before the individual is assigned. Drugs containing Chicory and Fumitory product or placebo were produced in the same shape and color and after coding were placed in sealed envelopes. Using opaque envelopes sealed with random sequences (Sequentially numbered, sealed, opaque envelopes) in which in this method each random sequence is recorded on a card and the cards are in the envelopes respectively. Are placed. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened in order and the assigned group of the participant is revealed, Blinding description: In this study, both chicory and fumitory products and placebo are made by the pharmacist in the laboratory and dumped and coded in similar batteries that only the pharmacist knows about the codes and in the same way it will be given for researchers and basis on randomization finally for participants both so the researcher and the participant are blinded. 2-3 Breasts cancer. Intervention 1: Intervention group1: Chicory and Fumitory products, obtained by at Institute of Medicinal Plants of shahid beheshti University, 5 ml per day until the end of the fourth weeks of intervention. In the preparation of this product, 20 grams of chicory seeds and 10 grams of aerial organs of fumitory are boiled and smoothed with 150 ml of water. 70 ml of this extract is combined with 35 grams of sugar and 20 ml of vinegar. Intervention 2: Intervention group 2 : Placebo product, obtained by at Institute of Medicinal Plants of shahid beheshti University 5 ml per day until the end of intervention time. for produce this placebo, Oxymel syrup is used that combined with 1000 g sugar and 500 ml water and 250ml vinegar ,they are heated To achieve the desired consistency, Then the natural color appropriate to the drug is added to it. 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 dissertation project thesis defence To whom: Public Conditions: For research reasons Where to obtain: Shahid Beheshti University of Medical Sciences How to obtain: Approving by responsible office Comments:
public Nematollah Rostami
Yadegare Imam Highway Saadat Abad St
Tehran Iran (Islamic Republic of) 1998734383 +98 21 2207 4087 alireza.khosropanah1455@gmail.com Shahid Beheshti University of Medical Sciences scientific Nematollah Rostami
Yadgare Imam Highway .Saadat Abad St
Tehran Iran (Islamic Republic of) 1998734383 +98 21 2207 4087 alireza.khosropanah1455@gmail.com 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) Estrogen suppressive hormone therapy 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, Pregabalin, Clonidine, Aspirin, Vitamin E, Omega 3, Phytoestrogenic supplements Use of high phytoestrogenic diet Allergy to distillated of Chicory and Fumitory Kidney test (BUN,CR) is not in normal range Laboratory range Liver enzymes AST and ALT are more than twice the normal range Laboratory range and Total Bilirubin ≥2 CD50 Malignant neoplasm of breast Treatment - Drugs Placebo Intervention group1: Chicory and Fumitory products, obtained by at Institute of Medicinal Plants of shahid beheshti University, 5 ml per day until the end of the fourth weeks of intervention. In the preparation of this product, 20 grams of chicory seeds and 10 grams of aerial organs of fumitory are boiled and smoothed with 150 ml of water. 70 ml of this extract is combined with 35 grams of sugar and 20 ml of vinegar. Intervention group 2 : Placebo product, obtained by at Institute of Medicinal Plants of shahid beheshti University 5 ml per day until the end of intervention time. for produce this placebo, Oxymel syrup is used that combined with 1000 g sugar and 500 ml water and 250ml vinegar ,they are heated To achieve the desired consistency, Then the natural color appropriate to the drug is added to it. Number of hot flashes: This variable registered by patient based on definied daily in hot flashes daily registration form. Timepoint: At a specific time of night, it is recorded daily and continuously for one week before the intervention and four weeks during the intervention with drug or placebo. Method of measurement: Number of hot flashes average of frequency during a week according to based on Daily Hot flashes Diary. The severity of hot flashes in four levels , mild , moderate, severe and very severe, is recorded according to the definition registered by the patient in the Daily hot flashes Diary. Timepoint: At a specific time of night, it is recorded daily and continuously for one week before the intervention and four weeks during the intervention with drug or placebo. Method of measurement: Based on the weekly average daily hot flashes intensity based on the Daily hot flashes Diary. Shahid Beheshti University of Medical Sciences Approved 2019-05-12 Name of ethics committee Ethic committee of Shahid Beheshti University of Medical Sciences Velenjak st. Shahid Chamran Highway school of medicin 3th fioor Tehran Tehran Iran (Islamic Republic of)