A clinical trial comparing the effect of Iris and placebo on clinical symptoms in patients with adult asthma: A double-blind, randomized study

In this research, we investigate the Iris pill's effect on treatment and lung function improvement in adults with asthma.

In a controlled clinical trial, with parallel groups, double-blind, block randomization, patients receive Iris tablets half an hour after each meal or Placebo tablets half an hour after each meal 3 times a day in the experimental and control groups. This study will be phase 3 on 72 patients. Excel software will be used to randomize the list of numbers.

Patients with mild to moderate asthma aged 18-60 years, referred to the lung clinic of Luqman Hospital in Tehran, who meet the inclusion criteria, will be selected using a table of random numbers. Patients are divided into two intervention and control groups. The prescribing physician, assistant, and patient will not know any of the contents of the drug and the code will be written on the file (double-blind).

Inclusion criteria: mild to moderate asthma؛ age 18-60; Luqman hospital pulmonary clinic. Non-inclusion criteria: Patients in need of hospitalization; for patients with underlying diseases such as COPD, CF, heart failure, GERD, bronchiectasis, pulmonary embolism, sarcoidosis؛ Smokers; BMI> 29; Pregnant and lactating women

Intervention group: Iris tablets; Iris tablets half an hour after each meal 3 times a day. Control group: placebo; placebo tablets half an hour after each meal 3 times a day.

Shortness of breath; Cough; Wheezing; Sputum; Spray consumption; The backwardness of daily tasks; Rate of waking up early morning due to shortness of breath; Rate of not sleeping at night due to shortness of breath; Chest pain; heaviness in the chest; Full ACT score

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

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).