A randomized, double-blind, controlled clinical study on the intervention of Shudi Suoyang Decoction granule in PF-ILD with kidney essence deficiency syndrome

Phase 1

Recruiting

• Conditions: Interstitial lung disease

• Registration Number: ITMCTR2100004924
• Lead Sponsor: Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Aged 18 to 80 years;
2.PF-ILD diagnostic criteria of wetern medicine
Referring to internal medicine (8th Edition), practical interstitial lung disease (2nd Edition, people's Health Publishing House), IIP new international multidisciplinary classification of non IPF interstitial lung disease revised by ATS / ERS in 2013, and PF-ILD literature review, the clinical diagnostic characteristics are as follows:
(1)The symptoms were chronic cough, progressive dyspnea and decreased activity tolerance.
(2)Pulmonary auscultation and crackling sound with or without clubbed fingers, combined with connective tissue diseases can have the corresponding manifestations of primary disease, such as rash, joint pain, joint swelling, Raynaud's phenomenon and so on;
(3)The diagnosis of ILD can meet one of the following requirements: idiopathic pulmonary fibrosis (IPF), hypersensitive pneumonia (HP), autoimmune disease-related ILDs (including rheumatoid arthritis related interstitial lung disease, systemic sclerosis related interstitial lung disease and mixed connective tissue disease-related interstitial lung disease), idiopathic non-specific interstitial pneumonia (ISIP) Unclassified idiopathic interstitial pneumonia (unclassified IIP) and other ILDs (including sarcoidosis, environment related ILDs, fibrous ILDs caused by other causes);
(4)Chest HRCT showed diffuse abnormal changes in both lungs, mainly manifested as honeycomb shadow, grid shadow, tractive bronchodilation shadow, with or without ground glass shadow, whose area should be less than the grid area.
(5)Pulmonary fibrosis like changes caused by pulmonary infection and tumor diseases were excluded.
(6)Under the condition of treatment, one of the following conditions can be met within 24 months:
1)Relative decrease of forced vital capacity (FVC) >= 10%;
2)The relative decrease of FVC was more than 5%, and the absolute decrease of the predicted percentage of carbon monoxide dispersion capacity (DLCO) was more than 15%;
3)The relative decrease of FVC was more than 5%, and HRCT showed increased fibrosis (according to the evaluation of imaging experts);
4)FVC relative decrease >= 5% with aggravation of respiratory symptoms;
5)Aggravation of respiratory symptoms with progressive performance on HRCT (according to the evaluation of imaging experts).
(7)At present, there is no strict and unified disease diagnosis, this study only according to the international general diagnostic standards for western medicine disease diagnosis.
3.Pulmonary function test: FVC (forced vital capacity) predicted value >= 45%, and DLCO sb (carbon monoxide dispersion volume) >= 30% and < 80%;
4.PF-ILD diagnostic criteria of TCM Syndromes
Referring to the Chinese medicine industry standard of the people's Republic of China - diagnosis standard of TCM syndrome, combined with the case observation and clinical diagnosis and treatment experience of the research group in recent 7 years, it is found that the TCM syndrome of PF-ILD is mainly kidney essence deficiency syndrome, and the specific diagnostic characteristics are as follows: cough less phlegm, white sputum color, aggravation of peculiar smell after activity; Short breath, especially difficult to inhale, shallow breathing, aggravation of movement, mental fatigue, or fatigue, waist and knee soreness, chilly limbs, frequent urination, or nocturia, or cough enuresis, tongue light dark, mossy white, pulse thin slow weakness, especially in the ulna. The dia

Exclusion Criteria

1.Pregnant or lactating women, or preparing for pregnancy during treatment;
2.Allergic to therapeutic drugs or components of therapeutic drugs;
3.They were complicated with chronic obstructive pulmonary disease, asthma, pulmonary embolism, etc.;
4.Patients with severe primary diseases, such as severe cardiac insufficiency, liver and kidney dysfunction, hematopoietic system disorders, tumors of various organs, as well as psychiatric history and communication difficulties;
5.There is clinical evidence of active infection, such as acute bronchitis, pneumonia, urinary tract infection, acute gastroenteritis or cellulitis;
6.Unable to cooperate with lung function test;
7.Patients have participated in other drug clinical trials or within one month;
8.During acute exacerbation of interstitial lung disease (AE).

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess changes in dyspnea and quality of life score;Assess cough and change in quality of life score;

Secondary Outcome Measures

Name	Time	Method
Quality of life and health assessment;Assess cough sensitivity;Changes in forced lung capacity;Absolute change in predicted percentage of carbon monoxide dispersion (DLCO SB) from baseline;PF-ILD-related deaths;Hospitalization for transplant or non-selective respiratory reasons;Acute exacerbations;Traditional Chinese medicine symptom score;The six-minute-walking distance;