Status:
TERMINATED
Clinical Trial of Chinese Herbal Medicine for Idiopathic Pulmonary Fibrosis (IPF)
Lead Sponsor:
The University of Hong Kong
Collaborating Sponsors:
Queen Mary Hospital, Hong Kong
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
40-75 years
Phase:
NA
Brief Summary
This open label clinical study will be conducted in School of Chinese Medicine Clinics at The University of Hong Kong (HKU) to preliminarily determine whether treatment with the herbal formula PROLUNG...
Detailed Description
Background Idiopathic pulmonary fibrosis (IPF) is a dreadful disease characterized by progressive impairment in quality of life, increasingly limited physical function, and an early death from respira...
Eligibility Criteria
Inclusion
- Either gender aged 40-75;
- Has a diagnosis of IPF, made by a respiratory expert based on International Classification of Diseases (ICD-10);
- No participation in another clinical study within 4 weeks of study start.
- Participation in this study must be voluntary and not coerced.
Exclusion
- Have received lung transplantation.
- Any condition that may compromise patient safety.
- Pregnant women or women trying to become pregnant will be excluded from the study.
- History of drug or alcohol abuse within 6 months of study start.
- History of immunocompromise, including a positive HIV test result.
- Impaired liver and renal functions.
- Known allergies to any Chinese herbs and participants with numerous or severe allergies to any allergen.
- Pre-existing conditions including renal failure, chronic renal problems, chronic hepatitis, other pulmonary problems, diabetes, and heart problems will be excluded from the study.
- Either mentally incompetent or are unable to give informed consent because of the language barrier.
- Taking the following drugs, even as part of their current treatment regimen for IPF: pirfenidone, nintedanib, antiplatelet drugs (including aspirin, clopidogrel (Plavix), and dipyridamole (Persantine), anticoagulant drugs (including warfarin (Coumadin), enoxparin (Lovenox), and heparin), cardiac glycosides (e.g. digoxin), sedatives and sedative-containing drugs (including barbiturates, narcotic analgesics, benzodiazepines, and antihistamines), and traditional Chinese herbal medicines or granules, or other herbal medicines or supplements.
Key Trial Info
Start Date :
August 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2020
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03274544
Start Date
August 14 2018
End Date
June 1 2020
Last Update
April 28 2021
Active Locations (1)
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1
Queen Mary Hospital
Hong Kong, Hong Kong