]>
IRCT20100420003760N7 IRCT 2023-04-17 Khoram-Abad University of Medical Sciences Effect of sublingual soft gel of essential oil of Pistacia atlantica in asthma 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 2023-05-24 anticipated 35 Complete https://irct.ir/trial/69187 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Asthma. Intervention 1: Intervention group1: The group receiving common treatment and 200 mg sublingual soft gel containing 40 mg of Pistacia atlantica oleoresin essential oil (Soft gel is made according to the order of the project manager in Kashan Barij Essence Company). Intervention 2: Intervention group2: The group receiving common treatment and 200 mg sublingual soft gel containing 75 mg of Pistacia atlantica oleoresin essential (Soft gel is made according to the order of the project manager in Kashan Barij Essence Company). Intervention 3: Intervention group3: The group receiving common treatment and 200 mg sublingual soft gel containing 150 mg of Pistacia atlantica oleoresin essential oil (Soft gel is made according to the order of the project manager in Kashan Barij Essence Company). Intervention 4: Control group 1: The group receiving common treatment and 200 mg sublingual soft gel containing 0 mg of Pistacia atlantica oleoresin essential oil (Soft gel is made according to the order of the project manager in Kashan Barij Essence Company). Yes - There is a plan to make this available What will be shared: Only part of the data, such as information about the main consequence or similar, can be shared When: Start the access period 18 months after printing the results. To whom: Data will only be available to researchers working at academic and scientific institutions Conditions: The data will only be used to inform the results of the study Where to obtain: Lorestan University of Medical Sciences How to obtain: 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 Comments:
public Marzieh Rashidipour
No. 140, Razi Ave. Pajohandeh Blvd, Herbal Research Center
Khorramabad Iran (Islamic Republic of) 6814989468 +98 66 3312 0172 m_rashidi80@yahoo.com Khoram-Abad University of Medical Sciences scientific Marzieh Rashidipour
No. 140, Razi Ave. Pajohandeh Blvd, Herbal Research Center
Khorramabad Iran (Islamic Republic of) 6814989468 +98 66 3312 0172 m_rashidi80@yahoo.com Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) 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 15 years no limit Both 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 J45 Asthma Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo Intervention group1: The group receiving common treatment and 200 mg sublingual soft gel containing 40 mg of Pistacia atlantica oleoresin essential oil (Soft gel is made according to the order of the project manager in Kashan Barij Essence Company) Intervention group2: The group receiving common treatment and 200 mg sublingual soft gel containing 75 mg of Pistacia atlantica oleoresin essential (Soft gel is made according to the order of the project manager in Kashan Barij Essence Company). Intervention group3: The group receiving common treatment and 200 mg sublingual soft gel containing 150 mg of Pistacia atlantica oleoresin essential oil (Soft gel is made according to the order of the project manager in Kashan Barij Essence Company) Control group 1: The group receiving common treatment and 200 mg sublingual soft gel containing 0 mg of Pistacia atlantica oleoresin essential oil (Soft gel is made according to the order of the project manager in Kashan Barij Essence Company). The times of waking up with an asthma attack during the past week (zero to six according to the questionnaire). Timepoint: Before, and after intervention. Spirometry time 0 and 30. Method of measurement: Through Asthma Control Questionnaire and spirometry. The severity of symptoms during the past week (zero to six according to the questionnaire). Timepoint: Before, and after intervention. Spirometry time 0 and 30. Method of measurement: Through Asthma Control Questionnaire and spirometry. The amount of restriction in daily activities during the past week (zero to six according to the questionnaire). Timepoint: Before, and after intervention. Spirometry time 0 and 30. Method of measurement: Through Asthma Control Questionnaire and spirometry. The severity of breath during the past week (zero to six according to the questionnaire). Timepoint: Before, and after intervention. Spirometry time 0 and 30. Method of measurement: Through Asthma Control Questionnaire and spirometry. Wheezing during the past week (zero to six according to the questionnaire). Timepoint: Before, and after intervention. Spirometry time 0 and 30. Method of measurement: Through Asthma Control Questionnaire and spirometry. The daily puffs of short-acting inhaled bronchodilators used during the past week (zero to six according to the questionnaire). Timepoint: Before, and after intervention. Spirometry time 0 and 30. Method of measurement: Through Asthma Control Questionnaire and spirometry. Khoram-Abad University of Medical Sciences Approved 2023-03-15 Ethic Committee of Lorestan University of Medical Sciences No 20, Anooshirvan Rezaei Square, Lorestan University of Medical Sciences Khorramabad Lorestan Iran (Islamic Republic of)