Evaluation of the effect of sublingual soft gel containing Pistacia atlantica oleoresin essential oil on symptomatic and spirometric improvement of patients with moderate to severe asthma compared with standard treatment: A triple-blinded, randomized, placebo-controlled trial

Determining the effect of sublingual soft gel containing Pistacia atlantica oleoresin essential oil on symptomatic and spirometric improvement in patients with moderate to severe asthma compared to standard treatment: a randomized controlled clinical trial

A controlled, parallel-group, triple-blind, randomized, phase 3 clinical trial on 140 patients. The method of random allocation of eligible patients to the study groups is also using stratified random allocation

Patients diagnosed with moderate or severe asthma are randomly divided into groups receiving three doses of soft gel and a placebo group. The patients are evaluated for 4 weeks and spirometry is recorded at the end of 4 weeks. The patients will be evaluated in the office of a lung specialist in Shahid Rahimi Hospital in Khorramabad.

Inclusion criteria: Patients aged 15 years and older who referred to the asthma and allergy specialist's office with a diagnosis of moderate or severe allergic asthma. Exclusion criteria: Having other respiratory diseases except asthma Pregnant and lactating women People with a history of drug allergy Taking anti-leukotriene drugs People who use supplements or other inhalation and non-inhalation drugs Having special diseases such as dialysis patients (hemophilia, thalassemia, and MS) and incurable (cystic fibrosis (CF), mucopolysaccharidosis (MPS), spinal muscular atrophy (SMA), metabolic diseases, and autism) lung cancer

1- The group receiving common treatment and 200 mg sublingual soft gel containing 0 mg of Pistacia atlantica oleoresin essential oil. 2- The group receiving common treatment and 200 mg sublingual soft gel containing 40 mg of Pistacia atlantica oleoresin essential oil. 3- The group receiving common treatment and 200 mg sublingual soft gel containing 75 mg of Pistacia atlantica oleoresin essential oil. 4- The group receiving common treatment and 200 mg sublingual soft gel containing 150 mg of Pistacia atlantica oleoresin essential oil.

Times of waking up with an asthma attack ; Severity of symptoms ; The amount of restrictions in daily activities; The severity of breath ; wheezing; The average number of daily puffs of short-acting inhaled bronchodilators used during the past week

Random allocation of patients into four groups and also using stratified random allocation. In this way, classes are made based on age group (below 40 years and older or equal to 40 years), gender (male and female) and severity (moderate or severe). Within each class, random permutation blocks are used to assign samples to the required groups. To create random sequences, letters A, B , C or D(corresponding to the experimental group) will be used as follows. ABCD: 0-3 ABDC: 4-7 ACBD: 8-11 ACDB:12-15 . . DABC DBAC DCAB DCBA: 92-95 Then a corner of the table of random numbers is selected and two-digit numbers are read from top to bottom, and finally, according to the read number, a random sequence of letters A to D is registered in the desired floor. Finally, a random sequence of letters A to D (corresponding to the 4 experimental groups) will be created in each class of all existing classes, and the samples will be assigned to 4 groups based on this random sequence.

A random sequence of letters A to D (corresponding to 4 experimental groups) will be created in each class from all the existing classes, and the samples will be assigned to 4 groups based on this random sequence. This study will be triple blind, which means that the pain intensity assessor, the patient and the data analyst are not aware of the type of treatment assigned to the patient. In addition, the decipherer is not a member of the research team, and the sublingual tablets in all groups are completely identical in appearance. Data registration in the statistical software and data analysis is done by the statistical consultant without mentioning the names of the groups.

Only part of the data, such as information about the main consequence or similar, can be shared

Start the access period 18 months after printing the results.

Data will only be available to researchers working at academic and scientific institutions

The data will only be used to inform the results of the study

Lorestan University of Medical Sciences

Refer to Lorestan University of Medical Sciences, Vice Chancellor of Research and Technology, Research Projects Department, Management of Research Projects Department, 066333120175, Mrs. Sajedi , fax:066333120173 call mrs. zarei 0989167083314