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Modified Maimendong Decoction in the Treatment of Patients with Idiopathic Pulmonary Fibrosis: Study Protocol for a Randomized Controlled Trial

Modified Maimendong Decoction in the Treatment of Patients with Idiopathic Pulmonary Fibrosis: Study Protocol for a Randomized Controlled Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036021
Enrollment
Unknown
Registered
2020-08-21
Start date
2020-09-01
Completion date
Unknown
Last updated
2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

Sponsors

Hospital of Chengdu University of traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Between the ages of 18 and 75, male and female; 2. Diagnosis according to guidelines of the Idiopathic Pulmonary Fibrosis by ATS/ERS/JRS/ALAT in 2018; 3. In line with the diagnostic criteria of TCM syndrome "Qi and Yin deficiency"; 4. Good ability to read, understand and write research-related materials, and voluntary compliance with all testing requirements; 5. Volunteer for a study, sign an informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with acute exacerbation of IPF or those with FVC% < 50% or those with obvious pulmonary infection should be treated with anti-infection therapy; 2. Patients with chronic obstructive pulmonary disease, interstitial lung disease, active pulmonary tuberculosis, bronchiectasis and other chronic lung diseases that need intervention or treatment; 3. Patients with severe mental and psychological disorders, cardiovascular, liver and kidney, endocrine, hematopoietic system, malignant tumor and other serious primary diseases; 4. Patients who had taken glucocorticoid within 1 month; those who had taken immunosuppressants within 1 month; those who had taken Pirfenidone, Nintedanib or antacid within 1 month; 5. Patients who are unwilling or unable to change the current treatment plan; 6. Patients who are known to be allergic to the test drug or some traditional Chinese medicine in the test drug; 7. Women in lactation, pregnancy or preparing for pregnancy; 8. Patients who have participated in other clinical studies in recent six months.

Design outcomes

Primary

MeasureTime frame
Forced vital capacity;Times of acute exacerbation;

Secondary

MeasureTime frame
SGRQ score;FEV1/FVC;DLCO;BNP;TCM syndrome score;

Countries

China

Contacts

Public ContactLiao Tingting

Hospital of Chengdu University of traditional Chinese Medicine

liaotingting00@163.com+86 18982196620

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026