Clinical Trial of Chinese Herbal Medicine for Idiopathic Pulmonary Fibrosis (IPF)
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|ClinicalTrials.gov Identifier: NCT03274544|
Recruitment Status : Not yet recruiting
First Posted : September 7, 2017
Last Update Posted : May 7, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Pulmonary Fibrosis||Other: PROLUNG||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effectiveness of an Empirical Chinese Medicine Formulation for Idiopathic Pulmonary Fibrosis: an Open Label Clinical Trial|
|Estimated Study Start Date :||May 14, 2018|
|Estimated Primary Completion Date :||August 31, 2019|
|Estimated Study Completion Date :||August 31, 2020|
Herbal formula treatment PROLUNG in additional to current therapy
Chinese herbal medicine formula PROLUNG with individual herbs of the formula are listed as follows (weight in granule preparation):
- Annual rate of change in forced expiratory vital capacity (FVC) [ Time Frame: Baseline, 6 month ]Annual rate of change in forced expiratory vital capacity (FVC) will serve the primary outcome.
- Changes in SGRQ score [ Time Frame: Baseline, 1 month, 2 month, 3 month, 4 month, 5 month, 6 month ]The St. George's Respiratory Questionnaire (SGRQ) will be used to additionally assess respiratory functions.
- Changes in SF-36 score [ Time Frame: Baseline, 1 month, 2 month, 3 month, 4 month, 5 month, 6 month ]The 36-Item Short Form Survey (SF-36) is a 36-question questionnaire to assess the quality of life of a participant in terms of physical and mental health.
- Changes in WHOQOL-BREF score [ Time Frame: Baseline, 1 month, 2 month, 3 month, 4 month, 5 month, 6 month ]The WHOQOL-BREF measures the physical and psychological health, the social relationships, and the environment of an individual.
- Changes in adverse events [ Time Frame: Baseline, 1 month, 2 month, 3 month, 4 month, 5 month, 6 month ]All patients will be monitored for adverse reactions of any kind including but not limited to idiosyncratic allergic reactions to some components of the treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03274544
|Contact: Zhang-Jin ZHANG, MMed, PhD||+852 3917 firstname.lastname@example.org|
|Contact: Marksman MAN, BCM BSc, PhD||+852 3917 email@example.com|
|Queen Mary Hospital||Not yet recruiting|
|Hong Kong, Hong Kong|
|Contact: James Chung-man HO, MBBS, MD +852 2255 4999 firstname.lastname@example.org|
|Principal Investigator: James Chung-man HO, MBBS, MD|
|Principal Investigator:||Zhang-Jin ZHANG, MMed, PhDemail@example.com|