Investigating the effectiveness and side effects of Deep Lung Support capsule as adjuvant treatment with prefenidone compared to placebo on clinical symptoms, pulmonary function tests and serum TGF-β levels in patients with idiopathic pulmonary fibrosis.

Determining the clinical and laboratory effects of Deep Lung Support in patients with idiopathic pulmonary fibrosis (IPF) treated with Pirfenidone

The clinical trial with two intervention groups, with parallel groups, double-blind, on 70 patients, and Random Number Generator software will be used for randomization.

Patients with idiopathic pulmonary fibrosis, referring to Shahid Modares and Masih Deneshvari hospitals in Tehran, will be included in the study. The study will be double-blind, and the subjects and outcome assessors will be unaware of the drug or placebo allocation. For this purpose, capsules with the same color, shape, size and smell as Deep Long Support capsules will be used.

Inclusion criteria: being at the age of 40-80 years, FVC>40 and less than or equal to 90%, DLCO>40 and less than or equal to 90%. Exclusion criteria: FEV1/FVC ratio less than 0.8, suffering from other interstitial lung diseases, history of chronic lung disease, active infection, treated with other IPF treatment methods, history of unstable heart or lung disease or worse in the last six months, pregnant and lactating women.

The intervention group will receive 1 oral capsule of deep lung support, three times a day, and the control group will receive a placebo medicine that contains cellulose and will be similar in shape, size and taste to the capsule of deep lung support. In both groups, Pirfenidone 267 mg, that in the first week 801 mg, in the second week 534 mg and from the third week onwards (maintenance treatment) 801 mg will be consumed three times a day.

Clinical symptoms (shortness of breath and cough)

A simple randomization method is used, in which the randomization unit is individual, and random sequence generation software (Random Number Generator software) is used. For concealment, non-transparent sealed envelopes with a random sequence is used . In this method, each random number created is recorded on a card and the cards are placed inside the envelopes in order.In order to maintain the random sequence of the envelopes on the outer surface, the numbering is done in the same order. Finally, the lids of the envelopes are glued and placed in a box. At the time of registration of the participants, based on the order of entry of the eligible participants into the study, one of the envelopes will be opened and the allocated group of that participant will be revealed.

This will be a double-blind study in which the participants and the researcher who evaluates the effectiveness of the drug will be unaware of the outcome of the variables. For this purpose, a capsule with the same shape, size, color and smell as the Deep Long Support capsule will be used as a placebo.