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IRCT20230509058135N1 IRCT 2023-05-22 Shahid Beheshti University of Medical Sciences The effect of deep lung support capsule in idiopathic pulmonary fibrosis 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. 2023-05-10 anticipated 70 Complete https://irct.ir/trial/70031 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Idiopathic Pulmonary Fibrosis. Intervention 1: Intervention group: In addition to pirfenidone tablets, each subject in the intervention group will take an oral deep lung support capsule three times a day with water. The way to take pirfenidone is that each capsule contains 267 mg of medicine, the first week: 267 mg capsules three times a day (801 mg daily) the second week: 534 mg capsules three times a day (1602 mg daily) and from the third week onwards (maintenance treatment): 801 mg three times a day (maximum allowed daily dose: 2403 mg) will be prescribed to the patient. Intervention 2: Control group: In this group, in addition to pirfenidone tablets, there will be a placebo that contains cellulose and will be similar to deep lung support capsules in terms of shape, size and taste. One capsule will be given to the patient three times a day.The way to take pirfenidone is that each capsule contains 267 mg of medicine, the first week: 267 mg capsules three times a day (801 mg daily) the second week: 534 mg capsules three times a day (1602 mg daily) and from the third week onwards (maintenance treatment): 801 mg three times a day (maximum allowed daily dose: 2403 mg) will be prescribed to the patient. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Its release schedule is not yet known
public Sasan Tavana
Shahid Beheshti University of Medical Sciences,Faculty of Medicine, Koodak Yar St., Daneshjoo Blvd., Velenjek
Tehran Iran (Islamic Republic of) 1983969411 +98 21 23871 sasan.tavana@yahoo.com Shahid Beheshti University of Medical Sciences scientific Sasan Tavana
Shahid Beheshti University of Medical Sciences,Faculty of Medicine, Koodak Yar St., Daneshjoo Blvd., Velenjek
Tehran Iran (Islamic Republic of) 1983969411 +98 21 23871 sasan.tavana@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Forced vital capacity (FVC) greater than 40% and less than or equal to 90% Diffusing capacity of the lungs for carbon monoxide (DLCO) greater than or equal to 40% and less than or equal to 90% 40 years 80 years Both Having an FEV1/FVC ratio of less than 0.8 (after bronchodilator administration) at screening Suffering from other interstitial lung diseases, history of asthma or chronic lung disease, active infection, being treated with other IPF treatment methods such as immunosuppressives and cytokine regulating agents. History of unstable or worsening heart or lung disease (except IPF) in the past six months Pregnant and lactating women J84.112 Idiopathic pulmonary fibrosis Treatment - Drugs Placebo Intervention group: In addition to pirfenidone tablets, each subject in the intervention group will take an oral deep lung support capsule three times a day with water. The way to take pirfenidone is that each capsule contains 267 mg of medicine, the first week: 267 mg capsules three times a day (801 mg daily) the second week: 534 mg capsules three times a day (1602 mg daily) and from the third week onwards (maintenance treatment): 801 mg three times a day (maximum allowed daily dose: 2403 mg) will be prescribed to the patient. Control group: In this group, in addition to pirfenidone tablets, there will be a placebo that contains cellulose and will be similar to deep lung support capsules in terms of shape, size and taste. One capsule will be given to the patient three times a day.The way to take pirfenidone is that each capsule contains 267 mg of medicine, the first week: 267 mg capsules three times a day (801 mg daily) the second week: 534 mg capsules three times a day (1602 mg daily) and from the third week onwards (maintenance treatment): 801 mg three times a day (maximum allowed daily dose: 2403 mg) will be prescribed to the patient. Clinical symptoms (cough and shortness of breath). Timepoint: Once before starting treatment and once 3 months after that. Method of measurement: "Rate of perceived exertion" and "cough symptom score" scales. Pulmonary function tests. Timepoint: Once before starting treatment and once 3 months after that. Method of measurement: by spirometry. TGF-β serum level. Timepoint: Once before starting treatment and once 3 months after that. Method of measurement: by blood sample testing. Shahid Beheshti University of Medical Sciences Approved 2023-05-02 Ethics Committee of Shahid Beheshti University of Medical Sciences Deputy of research and technology of Shahid Beheshti University of Medical sciences, Shahid Arabi St.,Yemen St., Shahid Chamran Highway. Tehran Tehran Iran (Islamic Republic of)