Lung Dispersing, Turbid Descending and Gut Clearing Decoction for Bronchiectasis

NCT03177889 | Unknown DMC

• 1 other identifier: GWJ-TCM-2017
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

Bronchiectasis is a chronic airway disease which confers significant healthcare burden, with limited therapeutic approaches. From the perspective of traditional Chinese medicine, congenital insufficiency of the lung, spleen and kidney, when coupled with external injury or mood impairment, may collectively contribute to bronchiectasis pathogenesis due to heat trapping in the phlems, congestion of wind evils and stagnation of blood. Here, the investigators will explore the Lung Dispersing, Turbid Descending and Gut Clearing Decoction (LTGD) which targets at expelling the wind evil in patients with bronchiectasis. The investigators sought to conduct a multicenter, randomized cross-over trial which investigates the efficacy and safety of LTGD on clinically stable bronchiectasis.

Conditions

Bronchiectasis Adult; Traditional Chinese Medicine; Quality of Life; Exacerbation

Outcome Measures

Primary Outcomes (1)

• Changes in Bronchiectasis Health Questionnaire scores at month 6 compared with baseline

  Changes in Bronchiectasis Health Questionnaire scores at month 6 compared with baseline

  6 months

Secondary Outcomes (6)

• the frequency of bronchiectasis exacerbation

  6 months

• the time to the first bronchiectasis exacerbation

  6 months

• changes in forced expiratory volume in one second at month 6 compared with baseline

  6 months

• 24-hour sputum volume at month 6 compared with baseline

  6 months

• changes in sputum purulence score at month 6 compared with baseline

  6 months

Other Outcomes (8)

• changes in sputum hydrogen peroxide level at month 6 compared with baseline

  6 months

• changes in sputum catalase activity at month 6 compared with baseline

  6 months

• changes in sputum total antioxidant capacity at month 6 compared with baseline

  6 months

Study Arms (2)

Usual treatment

SHAM COMPARATOR

oral mucolytics \[ambroxol 30mg tid, or N-acetylcysteine 0.2g tid, serrapeptase 10mg tid, or carbocisteine 500mg tid\]

Combination Product: Traditional Chinese Medicine (TCM)

TCM treatment

ACTIVE COMPARATOR

Traditional Chinese Medicine plus oral mucolytics (described above); Agastache rugosus 5g, Scutellaria baicalensis 10g, Radix Puerariae 10g, Acorus tatarinowii schott 10g, Fructus Liquidambaris 5g, gypsum 15 g, Rheum officinale 5 g, Folium sennae 5 g, Codonopsis pilosula 10g, Radix Salviae Miltiorrhizae 10g, Lignum millettiae 10 g, Liquiritia glycyrrhiza 10 g

Combination Product: Traditional Chinese Medicine (TCM)

Interventions

Traditional Chinese Medicine (TCM) COMBINATION_PRODUCT

Traditional Chinese Medicine plus oral mucolytics \[ambroxol 30mg tid, or N-acetylcysteine 0.2g tid, serrapeptase 10mg tid, or carbocisteine 500mg tid\]; Agastache rugosus 5g, Scutellaria baicalensis 10g, Radix Puerariae 10g, Acorus tatarinowii schott 10g, Fructus Liquidambaris 5g, gypsum 15 g, Rheum officinale 5 g, Folium sennae 5 g, Codonopsis pilosula 10g, Radix Salviae Miltiorrhizae 10g, Lignum millettiae 10 g, Liquiritia glycyrrhiza 10 g Optional formulae: bile arisaema 15g, polygala tenuifolia 15g, Mangnolia officinalis 10g, Fructus aurantii immaturus 10g; Magnetite 15-30g and reddle15-30g

Also known as: TCM

TCM treatment; Usual treatment

Eligibility Criteria

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

You may qualify if:

• aged between 18 and 75 years;
• remained clinically stable (respiratory symptoms and lung function parameters not exceeding normal daily variations) for 4 consecutive weeks;
• no acute upper respiratory tract infections within 4 weeks;
• or more BEs within the previous 2 years

You may not qualify if:

• Other unstable concomitant systemic illnesses (i.e. coronary heart disease, recent cerebral stroke, severe uncontrolled hypertension, active gastric or duodenal ulcer, uncontrolled diabetes, malignancy, hepatic or renal dysfunction);
• Concomitant asthma, allergic bronchopulmonary aspergillosis, or active tuberculosis;
• Concomitant chronic obstructive pulmonary disease as the predominant diagnosis;
• Treatment with inhaled, oral or systemic antibiotics within 4 weeks;
• Type 2 respiratory failure needing oxygen therapy or non-invasive mechanical ventilation;
• Females during lactation or pregnancy;
• Poor understanding or failure to properly operate the instrument;
• Participation in other clinical trials within 3 months.

Sponsors & Collaborators

• Guangzhou Institute of Respiratory Disease: lead
• Guangdong Provincial Hospital of Traditional Chinese Medicine: collaborator

Related Publications (11)

• Pasteur MC, Bilton D, Hill AT; British Thoracic Society Non-CF Bronchiectasis Guideline Group. British Thoracic Society guideline for non-CF bronchiectasis. Thorax. 2010 Jul;65(7):577. doi: 10.1136/thx.2010.142778. No abstract available.

  PMID: 20627912 BACKGROUND

• Loukides S, Horvath I, Wodehouse T, Cole PJ, Barnes PJ. Elevated levels of expired breath hydrogen peroxide in bronchiectasis. Am J Respir Crit Care Med. 1998 Sep;158(3):991-4. doi: 10.1164/ajrccm.158.3.9710031.

  PMID: 9731036 BACKGROUND

• Horvath I, Loukides S, Wodehouse T, Kharitonov SA, Cole PJ, Barnes PJ. Increased levels of exhaled carbon monoxide in bronchiectasis: a new marker of oxidative stress. Thorax. 1998 Oct;53(10):867-70. doi: 10.1136/thx.53.10.867.

  PMID: 10193374 BACKGROUND

• Tsang KW, Chan K, Ho P, Zheng L, Ooi GC, Ho JC, Lam W. Sputum elastase in steady-state bronchiectasis. Chest. 2000 Feb;117(2):420-6. doi: 10.1378/chest.117.2.420.

  PMID: 10669685 BACKGROUND

• Quittner AL, O'Donnell AE, Salathe MA, Lewis SA, Li X, Montgomery AB, O'Riordan TG, Barker AF. Quality of Life Questionnaire-Bronchiectasis: final psychometric analyses and determination of minimal important difference scores. Thorax. 2015 Jan;70(1):12-20. doi: 10.1136/thoraxjnl-2014-205918. Epub 2014 Oct 16.

  PMID: 25323621 BACKGROUND

• Spinou A, Siegert RJ, Guan WJ, Patel AS, Gosker HR, Lee KK, Elston C, Loebinger MR, Wilson R, Garrod R, Birring SS. The development and validation of the Bronchiectasis Health Questionnaire. Eur Respir J. 2017 May 11;49(5):1601532. doi: 10.1183/13993003.01532-2016. Print 2017 May.

  PMID: 28495688 BACKGROUND

• Zheng J, Zhong N. Normative values of pulmonary function testing in Chinese adults. Chin Med J (Engl). 2002 Jan;115(1):50-4.

  PMID: 11930658 BACKGROUND

• Guan WJ, Gao YH, Xu G, Lin ZY, Tang Y, Li HM, Lin ZM, Zheng JP, Chen RC, Zhong NS. Sputum bacteriology in steady-state bronchiectasis in Guangzhou, China. Int J Tuberc Lung Dis. 2015 May;19(5):610-9. doi: 10.5588/ijtld.14.0613.

  PMID: 25868032 BACKGROUND

• Guan WJ, Gao YH, Xu G, Lin ZY, Tang Y, Gu YY, Liu GH, Li HM, Chen RC, Zhong NS. Sputum matrix metalloproteinase-8 and -9 and tissue inhibitor of metalloproteinase-1 in bronchiectasis: clinical correlates and prognostic implications. Respirology. 2015 Oct;20(7):1073-81. doi: 10.1111/resp.12582. Epub 2015 Jun 30.

  PMID: 26122009 BACKGROUND

• Zhang ZM, Ren PH, Wu ZJ, Zhang DP, Xie WJ. Personalized alternative therapy of intractable bronchiectasis-induced hemoptysis in a patient: syndrome differentiation and treatment according to individual physique category. J Thorac Dis. 2013 Jun;5(3):E115-7. doi: 10.3978/j.issn.2072-1439.2013.06.26. No abstract available.

  PMID: 23825784 RESULT

• Guan WJ, Gao YH, Xu G, Lin ZY, Tang Y, Li HM, Lin ZM, Zheng JP, Chen RC, Zhong NS. Impulse oscillometry in adults with bronchiectasis. Ann Am Thorac Soc. 2015 May;12(5):657-65. doi: 10.1513/AnnalsATS.201406-280OC.

  PMID: 25654540 RESULT

MeSH Terms

Interventions

Medicine, Chinese Traditional

Intervention Hierarchy (Ancestors)

Medicine, East Asian Traditional; Medicine, Traditional; Complementary Therapies; Therapeutics

Study Officials

• Wei-jie Guan, MD

  First Affiliated Hospital of Guangzhou Medical University

  STUDY CHAIR

Central Study Contacts

Wei-jie Guan, Ph.D.

CONTACT

+86-13826042052; battery203@163.com

Zhi-min Zhang, M.D.

CONTACT

+86-18928868345; zhangzhimin51666@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: June 4, 2017
• First Posted: June 6, 2017
• Study Start: December 31, 2021
• Primary Completion: August 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 11, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share