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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
Sponsor:
Collaborator:
Queen Mary Hospital, Hong Kong
Information provided by (Responsible Party):
Prof. Zhang Zhang-Jin, The University of Hong Kong

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.


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)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: PROLUNG
Herbal formula treatment PROLUNG in additional to current therapy
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

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


Contacts
Contact: Zhang-Jin ZHANG, MMed, PhD +852 3917 6445 zhangzj@hku.hk
Contact: Marksman MAN, BCM BSc, PhD +852 3917 6466 marksman@hku.hk

Locations
Hong Kong
Queen Mary Hospital Not yet recruiting
Hong Kong, Hong Kong
Contact: James Chung-man HO, MBBS, MD    +852 2255 4999    jhocm@hku.hk   
Principal Investigator: James Chung-man HO, MBBS, MD         
Sponsors and Collaborators
The University of Hong Kong
Queen Mary Hospital, Hong Kong
Investigators
Principal Investigator: Zhang-Jin ZHANG, MMed, PhD zhangzj@hku.hk

Publications:
Jin Gui Yao Lue (Essentials from the Golden Cabinet), written by Zhang Zhong-jing (about 150-219) in Later Han Dynasty.
Huangdi Neijing (The Book of Yellow Emperor's: a classic of internal medicine) written during the period 475-225 b.C. as a dialogue between the mythical Emperor Huangdi and his physician Qibo.
Tang ling Hua, Li Chun sheng. special onset of diffuse interstitial pulmonary fibrosis treated 13 cases reported. Traditional Chinese Medicine, 1997, 38 (1): 34 ~ 36.
Zhang. L. 1999. A Case Report on Chronic Lymphocytic Leukemia. Journal of Traditional Chinese Medicine Alumni 1: 15.
Chen, J.K., Chen, T.T. 2004. Chinese Medical Herbology and Pharmacology. City of Industry, CA: Art of Medicine Press, Inc. 1267pp.
Fruehauf, H. 1997. The Gingko. Cultural Background and Medicinal Usage in China. Journal of Chinese Medicine 55: 13-16.
Bensky, D., Clavey, S., Stöger, E. 2004. Chinese Herbal Medicine Materia Medica, 3rd Edition. Seattle: Eastland Press, Inc. 1311pp.
World Health Organization 1993. WHOQoL Study Protocol. WHO (MNH7PSF/93.9).
World Health Organization. 2004. WHO Quality of Life-BREF (WHOQOL-BREF). http://www.who.int/substance_abuse/research_tools/whoqolbref/en/, http://www.who.int/substance_abuse/research_tools/en/english_whoqol.pdf Accessed 09 April 2011.
Murphy, B., Herrman, H., Hawthorne, G., Pinzone, T., Evert, H. 2000. Australian WHOQoL instruments: User's manual and interpretation guide. Australian WHOQoL Field Study Centre, Melbourne, Australia.

Responsible Party: Prof. Zhang Zhang-Jin, Professor, Associate Director (Clinical Affairs), The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03274544     History of Changes
Other Study ID Numbers: UW 17-283
First Posted: September 7, 2017    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prof. Zhang Zhang-Jin, The University of Hong Kong:
Idiopathic Pulmonary Fibrosis
Chinese Medicine
Herbal Medicine

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial