]>
IRCT20200303046677N4 IRCT 2021-01-13 Shahid Beheshti University of Medical Sciences The effect of Iris tablet on adult asthma A clinical trial comparing the effect of Iris and placebo on clinical symptoms in patients with adult asthma: A double-blind, randomized study 2021-03-20 anticipated 72 Complete https://irct.ir/trial/52614 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A randomization table was created with the Excel software rand option. It was already clear that the process of reading random numbers was from top to bottom. Therefore, 36 random codes were assigned to the drug group and written on the drug, and the next 36 codes were written on the placebo, and the codes were kept confidential for use at the time of conclusion. Then, to create a balance in the number of samples assigned to each of the studied groups, blocking was used by random allocation software, which was able to generate random sequences by blocking method. The size of all the blocks is equal. In this two-group experiment, we will have blocks of size 4 (including 2 people in the intervention group and 2 people in the control group). Blocking is done by a person who is not involved in the study, and the content of the blocks is kept confidential until the end of the study. Randomization unit: individual Randomization tool: Random number table, Blinding description: The capsules code will be written to the file. The Prescribing physician, assistant, and patient will not be aware of any capsules content. (Double-blind). 3 Asthma. Intervention 1: Intervention group: Iris group;8 Kg of Iris root, 2 kg of black pepper, and 2 kg of Valeriana officinalis are ground, 2 kg of Dorema ammoniacum gum is dissolved in vinegar and then filtered and dried in an oven, and the result is ground. The powder obtained from steps 1 and 2 Mix in a ribbon blender with microcrystalline cellulose, povidone, calcium diphosphate calcium, and magnesium stearate for one hour. The powder obtained from step 3 is transferred to the press chamber, and during the direct pressing process, 500 mg tablets are made. Quality control of product components, microbial and fungal tests of components and final product are performed based on valid pharmacopeias and are standard. Is. This pill is standardized based on the number of polyphenols in the product. Intervention 2: Control group: Placebo; The placebo was prepared from corn starch in the same color and size capsules. Placebo was used similarly to the drug used by the intervention group. 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 There is no more information
public rasool choopani
NO 8. Shams ali, valiasr Ave.
Tehran Iran (Islamic Republic of) 1516745811 +98 21 8877 3521 rchoopani@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Rasool Choopani
No.8; Shams alley; Valiasr street
Tehran Iran (Islamic Republic of) 1516745811 +98 21 8877 3521 rchoopani@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Slight to moderate asthma Age between 18 to 60 years old 18 years 60 years Both Severe asthma and requires hospitalization Patients with underlying diseases such as COPD, CHF, heart failure, GERD, bronchiectasis, pulmonary embolism, sarcoidosis Smokers BMI> 29 Pregnant and lactating women J45 Asthma Treatment - Drugs Placebo Intervention group: Iris group;8 Kg of Iris root, 2 kg of black pepper, and 2 kg of Valeriana officinalis are ground, 2 kg of Dorema ammoniacum gum is dissolved in vinegar and then filtered and dried in an oven, and the result is ground. The powder obtained from steps 1 and 2 Mix in a ribbon blender with microcrystalline cellulose, povidone, calcium diphosphate calcium, and magnesium stearate for one hour. The powder obtained from step 3 is transferred to the press chamber, and during the direct pressing process, 500 mg tablets are made. Quality control of product components, microbial and fungal tests of components and final product are performed based on valid pharmacopeias and are standard. Is. This pill is standardized based on the number of polyphenols in the product. Control group: Placebo; The placebo was prepared from corn starch in the same color and size capsules. Placebo was used similarly to the drug used by the intervention group. Shortness of breath. Timepoint: At the beginning of the study; At the end of the fourth and eighth weeks. Method of measurement: Asthma Control Test questionnaire. Cough. Timepoint: At the beginning of the study; At the end of the fourth and eighth weeks. Method of measurement: Asthma Control Test questionnaire. Wheezing. Timepoint: At the beginning of the study; At the end of the fourth and eighth weeks. Method of measurement: Asthma Control Test questionnaire. Sputum. Timepoint: At the beginning of the study; At the end of the fourth and eighth weeks. Method of measurement: Asthma Control Test questionnaire. Spray consumption. Timepoint: At the beginning of the study; At the end of the fourth and eighth weeks. Method of measurement: Asthma Control Test questionnaire. The rate of backwardness from daily tasks. Timepoint: At the beginning of the study. At the end of the fourth and eighth week. Method of measurement: Asthma Control Test questionnaire. Rate of waking up early in the morning due to shortness of breath. Timepoint: At the beginning of the study. At the end of the fourth and eighth week. Method of measurement: Asthma Control Test questionnaire. The rate of not sleeping at night due to shortness of breath. Timepoint: At the beginning of the study. At the end of the fourth and eighth week. Method of measurement: Asthma Control Test questionnaire. Chest pain or tightness. Timepoint: At the beginning of the study; At the end of the fourth and eighth weeks. Method of measurement: Asthma Control Test questionnaire. Feeling heavy in the chest. Timepoint: At the beginning of the study; At the end of the fourth and eighth weeks. Method of measurement: Asthma Control Test questionnaire. Shahid Beheshti University of Medical Sciences Approved 2020-10-02 Vice-Chancellor in Research Affairs - Shahid Beheshti University of Medical Sciences 7th Floor; Bldg No.2 ؛ Shahid Beheshti University of Medical Sciences; Arabi Ave; Daneshjoo Blvd; Velenjak Tehran Tehran Iran (Islamic Republic of)