NCT03274544

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

Terminated NA Last updated 28 April 2021

What this trial tests

NA trial testing PROLUNG in Idiopathic Pulmonary Fibrosis in 6 participants. Terminated before completion.

Timeline

14 August 2018

Primary endpoint
27 May 2020

1 June 2020

Quick facts

Lead sponsor	The University of Hong Kong
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	14 August 2018
Primary completion	27 May 2020
Estimated completion	1 June 2020
Sites	1 location across Hong Kong

Drugs / interventions tested

• PROLUNG

Conditions studied

• Idiopathic Pulmonary Fibrosis — all drugs for Idiopathic Pulmonary Fibrosis →

Sponsor

The University of Hong Kong

Who can join

Adults 40 to 75, any sex, with Idiopathic Pulmonary Fibrosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Targeting Oxidative Stress as a Therapeutic Approach for Idiopathic Pulmonary Fibrosis.
   Estornut C, Milara J, Bayarri MA, Belhadj N, et al · · 2021 · cited 83× · PMID 35126133 · DOI 10.3389/fphar.2021.794997