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Study on technical specification and curative effect evaluation of warming lung and guyuan umbilical moxibustion for chronic obstructive pulmonary disease

Registration number：

ITMCTR2100005162

Date of Last Refreshed on：

2021-08-09

Date of Registration：

2021-08-09

Registration Status：

Prospective registration

Public title：

Study on technical specification and curative effect evaluation of warming lung and guyuan umbilical moxibustion for chronic obstructive pulmonary disease

English Acronym：

Scientific title：

Study on technical specification and curative effect evaluation of warming lung and guyuan umbilical moxibustion for chronic obstructive pulmonary disease

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

ChiCTR2100049802 ; ChiMCTR2100005162

Applicant：

Wang Minghang

Study leader：

Wang Minghang

Applicant telephone：

+86 18638392188

Study leader's telephone：

+86 18638392188

Applicant Fax：

Study leader's fax：

Applicant E-mail：

wmh107hn@163.com

Study leader's E-mail：

wmh107hn@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

19 Renmin Road, Jinshui District, Zhengzhou, He'nan

Study leader's address：

19 Renmin Road, Jinshui District, Zhengzhou, He'nan

Applicant postcode：

Study leader's postcode：

Applicant's institution：

The First Affiliated Hospital of Henan University of Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

AF/SC-08/03.2

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of the First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Date of approved by ethic committee：

2021/2/8 0:00:00

Contact Name of the ethic committee：

Wang Chunfang

Contact Address of the ethic committee：

19 Renmin Road, Jinshui District, Zhengzhou, He'nan

Contact phone of the ethic committee：

Contact email of the ethic committee：

Primary sponsor：

The First Affiliated Hospital of Henan University of Chinese Medicine

Primary sponsor's address：

19 Renmin Road, Jinshui District, Zhengzhou, He'nan

Secondary sponsor：

Country：

China

Province：

Beijing

City：

Institution
hospital：

National Administration of Traditional Chinese Medicine (NATCM)

Address：

1 Workers' Stadium Road West, Dongcheng District

Source(s) of funding：

2020 Special project for inheriting traditional Chinese medicine ancient books and literature and characteristic technologies

Target disease：

Chronic obstructive pulmonary disease

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

Main purpose: 1. Scientific evaluation of the clinical efficacy of warming lung and fixing element umbilical moxibustion in treating COPD:In this study, 220 patients with Chronic Obstructive Pulmonary Disease (COPD) at stable stage were randomized and controlled to evaluate the clinical efficacy and safety of moxibustion with warm lung and solid element in the umbilicus; 1. Establishment of technical specifications for the treatment of COPD with warm lung and solid element umbilical moxibustion: Based on clinical efficacy study data, screened the main factors affecting the clinical efficacy of warm lung and solid element umbilical moxibustion;The questionnaire of key technical experts of warm lung and solid element umbilical moxibustion was developed and investigated to determine the key technical indexes of clinical application;The main influencing factors were selected, the validation and comparative studies were carried out, the optimal indications/conditions were screened, the revised operation techniques were improved, and the technical specifications for the treatment of COPD with warm-lung and solid element umbilical moxibustion were finally formed.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

1. Patients with stable COPD diagnosis; 2. Aged 40 to 80 years; 3. Patients with qi deficiency syndrome (lung qi deficiency, lung spleen deficiency, lung and kidney qi deficiency); 4. The number of acute exacerbations in the previous year >= 1; 5. Not participating in clinical studies of other interventions within 1 month before enrollment; 6. Able to tolerate lung-warming and solid-element umbilical moxibustion therapy; 7. Voluntarily accept the treatment and sign the informed consent.

Exclusion criteria：

1. Pregnant and lactating women; 2. Confused, dementia, various mentally ill patients; 3. Combined with severe cardiac insufficiency; 4. Patients with active pulmonary tuberculosis, diffuse panbronchiolitis, pneumothorax, pleural effusion, and pulmonary embolism; 5. Combined with neuromuscular diseases affecting respiratory and motor function; 6. Combined tumor; 7. Severe liver and kidney disease (ALT/AST>=3 times normal value, glomerular filtration rate GFR<=29); 8. Those who are known to be allergic to the composition of moxibustion powder.

Study execute time：

From 2021-01-01

To      2022-12-31

Recruiting time：

From 2021-08-15

To      2021-09-15

Interventions：

110

Group：

Control group

Sample size：

Intervention：

western medicine routine treatment

Intervention code：

110

Group：

Experimental group

Sample size：

Intervention：

Warm lung and solid element umbilical moxibustion + western medicine routine treatment

Intervention code：

Total sample size ： 220

Countries of recruitment
and research settings：

Country：

China

Province：

He'nan

City：

Zhengzhou

Institution/hospital：

Henan Provincial Hospital of Traditional Chinese Medicine

Level of the institution：

Tertiary A

Country：

China

Province：

He'nan

City：

Zhengzhou

Institution/hospital：

The First Affiliated Hospital of Henan University of Chinese Medicine

Level of the institution：

Tertiary A

Country：

China

Province：

He'nan

City：

Zhengzhou

Institution/hospital：

The Third Affiliated Hospital of Henan University of Chinese Medicine

Level of the institution：

Tertiary A

Outcomes：

Outcome：

Number and severity of chronic obstructive pulmonary disease acute exacerbations

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Quality of life

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Evaluation of skin sensitization

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Effectiveness satisfaction questionnaire

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Clinical symptoms and signs

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

6 minutes walking distance

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Dyspnea classification

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Lung function

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Patient Reported Outcome

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

urine

Tissue：

Fate of sample 

Destruction after use

Note：

Sample Name：

blood

Tissue：

Fate of sample 

Destruction after use

Note：

Not yet recruiting

40
Min age years
80
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

The network random assignment method is adopted.The data management and statistical analysis unit formulated the random allocation scheme according to the test scheme, and randomly grouped through the network random allocation system.

Blinding：

IPD sharing：

Yes

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

https://www.happybreath.cn/

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Case of Form（CRF）

Data Managemen Committee：

Yes

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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