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

NCT03274544 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2021-04-28

No results posted yet for this study

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

Interventions

OTHER

PROLUNG

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

Sponsors & Collaborators

  • Queen Mary Hospital, Hong Kong

    collaborator OTHER

  • The University of Hong Kong

    lead OTHER

Principal Investigators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-14
Primary Completion
2020-05-27
Completion
2020-06-01

Countries

  • Hong Kong

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03274544 on ClinicalTrials.gov