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IRCT20100420003760N5 IRCT 2022-11-08 Khoram-Abad University of Medical Sciences Phytosome prepared from wild Pistacia Atlantica oleoresin on symptomatic and spirometric improvement of patients with asthma Evaluation of the effect of oral phytosome prepared from wild Pistacia atlantica oleoresin on symptomatic and spirometric improvement of patients with moderate to severe asthma compared with standard treatment: a randomized clinical trial 2022-10-30 anticipated 104 Complete https://irct.ir/trial/65838 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Other, 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 (8 blocks) are used to assign samples to the required groups. To create random sequences, letters A, B or C (corresponding to the experimental group) will be used as follows. A B C: 0-16 ACB : 17-32 B A C: 33-48 B C A: 49-64 C A B: 65-80 C B A: 81-96, Blinding description: The study is triple-blinded, the therapist (recorder of spirometry parameters and questioner of the clinical evaluation form), the patient and the data analyst are uninformed and the decoder is not a member of the research team. 3 Asthma. Intervention 1: Intervention group: receive the first dose(50) of phytosome formulation containing wild pistachio oleoresin in addition to conventional treatment. Intervention 2: Intervention group: receive the second dose(100) of phytosome formulation containing wild pistachio oleoresin in addition to conventional treatment. Intervention 3: Intervention group: receive the third dose(200) of phytosome formulation containing wild pistachio oleoresin in addition to conventional treatment. Intervention 4: Control group: receive placebo in addition to conventional treatment. 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 3320 4005 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 +98 916 667 4776 m.rashidipour@lums.ac.ir Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) Patients aged 15 years and older referring 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 or with a desire to become pregnant People with a history of drug allergy Taking anti-leukotriene drugs People who use supplements or other inhalation and non-inhalation drugs beyond what is allowed in this study. Having other special diseases such as kidney disease, tumor, etc. J45 Asthma Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: receive the first dose(50) of phytosome formulation containing wild pistachio oleoresin in addition to conventional treatment Intervention group: receive the second dose(100) of phytosome formulation containing wild pistachio oleoresin in addition to conventional treatment Intervention group: receive the third dose(200) of phytosome formulation containing wild pistachio oleoresin in addition to conventional treatment Control group: receive placebo in addition to conventional treatment The times of waking up with an asthma attack during the past week (zero to six according to the questionnaire); The severity of symptoms during the past week (zero to six according to the questionnaire); The amount of restriction in daily activities during the past week (zero to six according to the questionnaire); the severity of breath during the past week (zero to six according to the questionnaire); wheezing during the past week (zero to six according to the questionnaire).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 2021-05-18 Ethic Committee of Lorestan University of Medical Sciences No 20, Anooshirvan Rezaei Square, Lorestan University of Medical Sciences Khorramabad Lorestan Iran (Islamic Republic of)