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| Name | Class |
|---|---|
| Guangdong Provincial Hospital of Traditional Chinese Medicine | OTHER |
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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.
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. Symptomatic treatment may be effective and safe for ameliorating respiratory symptoms and hindering disease progression of bronchiectasis. Here, the investigators have explored 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual treatment | Sham Comparator | oral mucolytics [ambroxol 30mg tid, or N-acetylcysteine 0.2g tid, serrapeptase 10mg tid, or carbocisteine 500mg tid] |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| the frequency of bronchiectasis exacerbation | the frequency of bronchiectasis exacerbation | 6 months |
| the time to the first bronchiectasis exacerbation | the time to the first bronchiectasis exacerbation |
| Measure | Description | Time Frame |
|---|---|---|
| changes in sputum hydrogen peroxide level at month 6 compared with baseline | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei-jie Guan, Ph.D. | Contact | +86-13826042052 | battery203@163.com | |
| Zhi-min Zhang, M.D. | Contact | +86-18928868345 | zhangzhimin51666@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Wei-jie Guan, MD | First Affiliated Hospital of Guangzhou Medical University | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20627912 | Background | 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. | |
| 9731036 | 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. |
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| ID | Term |
|---|---|
| D008516 | Medicine, Chinese Traditional |
| ID | Term |
|---|---|
| D008518 | Medicine, East Asian Traditional |
| D008519 | Medicine, Traditional |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| 6 months |
| changes in forced expiratory volume in one second at month 6 compared with baseline | 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 | 24-hour sputum volume at month 6 compared with baseline | 6 months |
| changes in sputum purulence score at month 6 compared with baseline | changes in sputum purulence score at month 6 compared with baseline | 6 months |
| the proportion of patients isolated with Pseudomonas aeruginosa at month 6 compared with baseline | the proportion of patients isolated with Pseudomonas aeruginosa 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 | changes in sputum total antioxidant capacity at month 6 compared with baseline | 6 months |
| changes in airway resistance measured at 5 Hz at month 6 compared with baseline | changes in airway resistance measured at 5 Hz at month 6 compared with baseline | 6 months |
| changes in Quality-of-life-bronchiectasis questionnaire score at month 6 compared with baseline | changes in Quality-of-life-bronchiectasis questionnaire score at month 6 compared with baseline | 6 months |
| changes in sputum microbiota composition at month 6 compared with baseline | changes in sputum microbiota composition at month 6 compared with baseline | 6 months |
| Changes in AX at month 6 compared with baseline | Changes in AX at month 6 compared with baseline | 6 months |
| Changes in sputum superoxide dismutase activity at month 6 compared with baseline | Changes in sputum superoxide dismutase activity at month 6 compared with baseline | 6 months |
| 10193374 | 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. |
| 10669685 | 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. |
| 25323621 | 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. |
| 28495688 | 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. |
| 11930658 | Background | Zheng J, Zhong N. Normative values of pulmonary function testing in Chinese adults. Chin Med J (Engl). 2002 Jan;115(1):50-4. |
| 25868032 | 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. |
| 26122009 | 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. |
| 23825784 | Result | 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. |
| 25654540 | 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. |