Effect of asafoetida gum on lung function, pyroptosis factors and genes expression of IL-1b and IL-18 in asthmatic patients

Effect of asafoetida gum on lung function, pyroptosis factors and genes expression of IL-1b and IL-18 in asthmatic patients

A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Patients with moderate-to-severe asthma, after signing informed consent, will be randomly allocated to the following two groups. Placebo Group in which, patients (n=46) will receive placebo capsule and asafoetida Group in which, patients (n=46) will receive asafoetida 300 mg, twice a day, for 2 months. All subjects will receive the conventional asthma therapy during study. Double masking (including participant and outcomes assessor) will done. Main outcomes will be evaluated before starting treatment (step 0), one (step I) and two months (step II) after starting treatment.

Inclusion criteria (1) Diagnosis of moderate-to-severe asthma based on GINA guideline, (2) Patient consent to participate in the study Non-inclusion criteria (1) having systemic diseases, (2) having inflammatory disease, (3) having liver disease, (4) having autoimmune diseases and immune system defects, (5) taking drugs with antioxidant properties, (6) taking any herbal medicine, (7) having allergic to asafoetida, (8) pregnancy

(1) Placebo group in which, patients (n=46) will receive placebo capsule, twice a day, for 2 months (2) Asafoetida group in which, patients (n=46) will receive asafoetida 300 mg, twice a day, for 2 months

Respiratory symptoms; Chest wheeze; Pulmonary function tests; Cell blood count (CBC); Oxidative stress parameters; Lactate dehydrogenase (LDH) in serum; Gene expression of IL-18 and IL-1bin sputum

Block randomization method: In this method, the participants will be randomly divided into 2 groups labelled as A and B within a set of study participants, called a block with a fixed block size. For this aim, 23 blocks of with block size 4 are prepared and blocks are then randomly chosen to determine the patients’ assignment into the groups. this continues until the sample volume is completed.

Double blinded Masking Description: Drugs will be packed and labelled. No information on the randomization schedule or the contents of drug packs will be available to patients, investigators, care providers and outcomes assessors and they will be blinded. The patients will be blinded in the sense that they do not know whether they were receiving the placebo or asafoetida. They randomly assign to one of the two groups. Outcomes assessors shall be blinded as to what group the patient belongs to. One person in the project who does not belong to any of the groups of patients, investigators, care providers and outcomes assessors, will oversee on blinding method.

Shadi Ghafari is committed to presenting all the achievements of the project in accordance with the framework of Mashhad University of Medical Sciences.