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IRCT20170112031893N5 IRCT 2019-03-16 Ghoum University of Medical Sciences The effect of a Persian medicine product on patients with severe persistent asthma Comparison the effect of Persian medicine products (containing honey and flax seed) and placebo on Forced Expiratory Volume in First Second and wheezing intensity among patients with severe persistent asthma, A triple-blind randomized placebo-controlled trial 2019-03-21 anticipated 80 Complete https://irct.ir/trial/29488 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly allocated into two groups using random numbers table developed by Random Allocation Software, Blinding description: In this study, placebo will be used for blinding in which placebo is very similar to the main drug in terms of color and taste. Therefore, patients, statistical analyst and physicians won't bet aware of the allocation of patients to either drug or placebo group and someone outside the group is aware of the allocation of treatment. 3 Asthma. Intervention 1: Intervention group: The group will use Persian medicine product (containing honey and flax seed), 40 gram for 3 months, every day. Intervention 2: Control group: The group will use placebo, 40 gram every day for 3 months.The placebo contains edible color, aspartame and corn flour, and is made by Tehran University of Medical Sciences. No - There is not a plan to make this available Justification or reason for not sharing IPD is With attention to the type of study and publication of the article, there is no need to do this
public Hasan Adeli Nia
Clinical Research Development Center, Shahid Beheshti Hospital, Shahid Beheshti Blvd, Azadegan Sq, Qom, Iran
Qom Iran (Islamic Republic of) 3713649373 +98 25 3886 0146 huqom1394@yahoo.com Ghoum University of Medical Sciences scientific Muhammad Hossein Yusefi
Clinical Research Development Center, Shahid Beheshti Hospital, Shahid Beheshti Blvd, Azadegan Sq, Qom, Iran
Qom Iran (Islamic Republic of) 3713649373 +98 25 3886 0146 driran1390@yahoo.com Ghoum University of Medical Sciences Iran (Islamic Republic of) Patients with severe persistent asthma over a year Age group 12-80 12 years 80 years Both Kidney,liver,and heart failure based on the tests, history and physical exam High blood pressure more than 180 mm Hg Fever Pergnancy and lactation; J45.5 Severe persistent asthma Treatment - Drugs Placebo Intervention group: The group will use Persian medicine product (containing honey and flax seed), 40 gram for 3 months, every day. Control group: The group will use placebo, 40 gram every day for 3 months.The placebo contains edible color, aspartame and corn flour, and is made by Tehran University of Medical Sciences. Forced Expiratory Volume in First Second. Timepoint: Before and after the intervention (end of month 3). Method of measurement: Spirometry testing. Wheezing intensity determination. Timepoint: At the first of the study(before intervention) and 3 months after intervention. Method of measurement: History and physical exam with stethoscope. Ghoum University of Medical Sciences Approved 2019-01-29 Ethics committee of Qom University of Medical Sciences Vice chancellor for research of Qom University of Medical Sciences, Safashar road, Qom, Iran Qom Ghoum Iran (Islamic Republic of)