Clinical Trial of Chinese Herbal Medicine for Idiopathic Pulmonary Fibrosis (IPF)

NCT03274544 | Terminated

• 1 other identifier: UW 17-283
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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 could improve Idiopathic Pulmonary Fibrosis (IPF) symptoms, respiratory function and the quality of life of patients with IPF compared with pretreatment baseline. We propose to recruit 30 participants. The diagnosis and screening will be conducted by respiratory physicians. Those who meet the inclusion criteria will be referred by the expert to the PI. The PI will prescribe the formula in granule form to the participants in Traditional Chinese medicine (TCM) Clinics as usual. Patients will receive 6 months of the herbal treatment and 7 visits. Annual rate of change in forced expiratory vital capacity (FVC) will serve the primary outcome. The St. George's Respiratory Questionnaire (SGRQ) will be used to additionally assess respiratory functions. A standard questionnaire will be administered to obtain information on age, sex, marital status, education, social class, smoking behaviour and respiratory diseases. Other outcome measures include the 36-Item Short Form Survey (SF-36) and the World Health Organization Quality of Life assessment instrument (WHOQOLBREF) by each participant after enrollment.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Idiopathic Pulmonary Fibrosis; Chinese Medicine; Herbal Medicine

Outcome Measures

Primary Outcomes (1)

• Annual rate of change in forced expiratory vital capacity (FVC)

  Annual rate of change in forced expiratory vital capacity (FVC) will serve the primary outcome.

  Baseline, 6 month

Secondary Outcomes (4)

• Changes in SGRQ score

  Baseline, 1 month, 2 month, 3 month, 4 month, 5 month, 6 month

• Changes in SF-36 score

  Baseline, 1 month, 2 month, 3 month, 4 month, 5 month, 6 month

• Changes in WHOQOL-BREF score

  Baseline, 1 month, 2 month, 3 month, 4 month, 5 month, 6 month

• Changes in adverse events

  Baseline, 1 month, 2 month, 3 month, 4 month, 5 month, 6 month

Study Arms (1)

PROLUNG

EXPERIMENTAL

Herbal formula treatment PROLUNG in additional to current therapy

Other: PROLUNG

Interventions

PROLUNG OTHER

Chinese herbal medicine formula PROLUNG with individual herbs of the formula are listed as follows (weight in granule preparation): * Huang Qi (Radix Astragali Membranaceus): 2 g * Dan Shen (Radix Salviae Miltiorrhizae): 1 g * Jiang Huang (Rhizoma Curcumae Longae): 1 g * Yin Xing (Semen Gingko Bilobae): 1 g * Mai Men Dong (Tuber Ophiopogonis Japonoci): 1 g * Bai He (Bulbus Lilii): 1g * Jin Yin Hua (Flos Lonicerae Japonicae): 1 g * Zi Su Ye (Folium Perillae Frutescentis): 1 g * Yin Yang Huo (Herba Epimedii): 1g

PROLUNG

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead
• Queen Mary Hospital, Hong Kong: collaborator

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

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MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Zhang-Jin ZHANG, MMed, PhD

  zhangzj@hku.hk

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Associate Director (Clinical Affairs)

Study Record Dates

• First Submitted: September 4, 2017
• First Posted: September 7, 2017
• Study Start: August 14, 2018
• Primary Completion: May 27, 2020
• Study Completion: June 1, 2020
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

HK (1)