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The demonstration study of dominant diseases in the construction and demonstration of dynamic and static TCM clinical evaluation methodology based on the principle of syndrome element identification and state measurability : the study of TCM syndrome element characteristics of chronic kidney disease stage 5D ( Guange ) and the optimal example of individualized diagnosis and treatment of non-drug therapy ( moxibustion ) of ' Fatong disease syndrom

Registration number：

ITMCTR2024000808

Date of Last Refreshed on：

2024-12-12

Date of Registration：

2024-12-12

Registration Status：

Prospective registration

Public title：

The demonstration study of dominant diseases in the construction and demonstration of dynamic and static TCM clinical evaluation methodology based on the principle of syndrome element identification and state measurability : the study of TCM syndrome element characteristics of chronic kidney disease stage 5D ( Guange ) and the optimal example of individualized diagnosis and treatment of non-drug therapy ( moxibustion ) of ' Fatong disease syndrom

English Acronym：

Scientific title：

The demonstration study of dominant diseases in the construction and demonstration of dynamic and static TCM clinical evaluation methodology based on the principle of syndrome element identification and state measurability : the study of TCM syndrome element characteristics of chronic kidney disease stage 5D ( Guange ) and the optimal example of individualized diagnosis and treatment of non-drug therapy ( moxibustion ) of ' Fatong disease syndrom

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Qiao Xue

Study leader：

Qiu Moyan

Applicant telephone：

13269703258

Study leader's telephone：

010-84739181

Applicant Fax：

Study leader's fax：

Applicant E-mail：

bzs2410068_cacms@foxmail.com

Study leader's E-mail：

2958205507@qq.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

No.6 Zhonghuan South Road Chaoyang District Beijing East Campus of Beijing University of Chinese Medicine

Study leader's address：

Wangjing Hospital Huajiadi Street Chaoyang District Beijing

Applicant postcode：

Study leader's postcode：

Applicant's institution：

China Academy of Chinese Medical Sciences

Approved by ethic committee：

Approved No. of ethic committee：

WJEC-KT-2024-071-P002

Approved file of Ethical Committee：

View

Name of the ethic committee：

Medical Ethics Committee of Wangjing Hospital of CACMS

Date of approved by ethic committee：

2024/10/17 0:00:00

Contact Name of the ethic committee：

Li Hao

Contact Address of the ethic committee：

Wangjing Hospital of CACMS Huajiadi Street Chaoyang District Beijing

Contact phone of the ethic committee：

010-84739681

Contact email of the ethic committee：

wjyyec@126.com

Primary sponsor：

Wangjing Hospital of CACMS

Primary sponsor's address：

Wangjing Hospital Huajiadi Street Chaoyang District Beijing

Secondary sponsor：

Country：

China

Province：

Beijing

City：

Institution
hospital：

Wangjing Hospital of CACMS

Address：

Wangjing Hospital Huajiadi Street Chaoyang District Beijing

Source(s) of funding：

national key research and development program

Target disease：

Chronic kidney disease stage 5D

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

Objective1 : On the basis of conventional western medicine treatment in CKD-5D stage the diagnosis and treatment strategy of individualized adaptive non-drug therapy ( syndrome differentiation moxibustion ) was constructed. It provides a clinical research example of subgroup dynamic and static parallel group design of non-drug therapy for clinical research of traditional Chinese medicine. Objective2 : In order to construct a statistical prediction model to predict the efficacy of individualized diagnosis and treatment the diagnosis and treatment data of the Chinese medicine treatment group and the western medicine treatment group were collected.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

( 1 ) aged 18-80 years old ; ( 2 ) In line with the Western diagnostic criteria for end-stage renal disease ; ( 3 ) Conform to the diagnostic criteria of TCM syndromes of spleen and kidney yang deficiency syndrome spleen and kidney qi deficiency syndrome yin and yang deficiency syndrome qi and yin deficiency syndrome ; ( 4 ) Regular hemodialysis ≥ 3 months ; ( 5 ) clear consciousness no history of mental illness or personality disorder ; ( 6 ) Actively cooperate with the questionnaire survey and have good compliance with Chinese and Western medicine treatment orders ; ( 7 ) Volunteered to participate in the trial and signed the ' informed consent '.

Exclusion criteria：

(1) Life expectancy of less than one year; (2) Patients with severe cardiovascular and cerebrovascular diseases severe primary diseases acute infections malignant tumors severe gastrointestinal and liver diseases and fractures; (3) Poor adherence to medical instructions of Chinese and western medicine; (4) People who are allergic to Moxa tobacco and have a history of skin allergy; (5) Patients with local skin damage or infection and temperature sensory impairment; (6) Surgery within 3 months; (7) Pregnant or lactating women; (8) Mental illness psychological disorders etc. can not cooperate with investigators; (9) Participating in other clinical investigators within or near 1 month; (10) Solid heat syndrome Yin deficiency syndrome.

Study execute time：

From 2023-11-01

To      2026-10-31

Recruiting time：

From 2025-01-01

To      2026-04-30

Interventions：

1500

Group：

Western medicine group

Sample size：

Intervention：

conventional treatment of western medicine

Intervention code：

1500

Group：

tcm group

Sample size：

Intervention：

Conventional western medicine treatment + traditional Chinese medicine dialectical moxibustion

Intervention code：

Total sample size ： 3000

Countries of recruitment
and research settings：

Country：

China

Province：

Beijing

City：

Institution/hospital：

First Affiliated Hospital of Tsinghua University

Level of the institution：

Three-level synthesis

Country：

China

Province：

Beijing

City：

Institution/hospital：

Wangjing Hospital of CACMS

Level of the institution：

tertiary level

Country：

China

Province：

Beijing

City：

Institution/hospital：

Beijing University of Chinese Medicine Fangshan Hospital

Level of the institution：

tertiary level

Country：

China

Province：

Beijing

City：

Institution/hospital：

Dongzhimen Hospital of Beijing University of Chinese Medicine ( Tongzhou Campus )

Level of the institution：

tertiary level

Country：

China

Province：

Beijing

City：

Institution/hospital：

china academy of trad itional chinese medicine hospital

Level of the institution：

tertiary level

Country：

China

Province：

Beijing

City：

Institution/hospital：

Beijing Luhe Hospital

Level of the institution：

three-stage

Country：

China

Province：

Beijing

City：

Institution/hospital：

Seventh Medical Center of PLA General Hospital

Level of the institution：

tertiary level

Country：

China

Province：

fujian province

City：

Institution/hospital：

The Third People 's Hospital of Fujian University of Traditional Chinese Medicine

Level of the institution：

tertiary level

Country：

China

Province：

fujian province

City：

Institution/hospital：

Fujian University of Traditional Chinese Medicine Affiliated People 's Hospital

Level of the institution：

tertiary level

Country：

China

Province：

Beijing

City：

Institution/hospital：

Emergency Management Department Emergency General Hospital

Level of the institution：

Three-level synthesis

Country：

China

Province：

Beijing

City：

Institution/hospital：

Changping District Nankou Hospital

Level of the institution：

second order

Country：

China

Province：

Beijing

City：

Institution/hospital：

Beijing Hospital of Traditional Chinese Medicine Shunyi Hospital

Level of the institution：

tertiary level

Country：

China

Province：

Beijing

City：

Institution/hospital：

Beijing Aviation General Hospital

Level of the institution：

three-stage

Country：

China

Province：

fujian province

City：

Institution/hospital：

The Second People 's Hospital of Fujian University of Traditional Chinese Medicine

Level of the institution：

tertiary level

Country：

China

Province：

Beijing

City：

Institution/hospital：

Beijing University of Chinese Medicine Dongfang Hospital

Level of the institution：

tertiary level

Country：

China

Province：

fujian province

City：

Institution/hospital：

Zhongshan Hospital Affiliated to Xiamen University

Level of the institution：

tertiary level

Country：

China

Province：

Beijing

City：

Institution/hospital：

Beijing Guangwai Hospital

Level of the institution：

second order

Country：

China

Province：

Beijing

City：

Institution/hospital：

Beijing Changping District Hospital of Traditional Chinese Medicine

Level of the institution：

tertiary level

Country：

China

Province：

Beijing

City：

Institution/hospital：

Beijing Xinhua Hospital

Level of the institution：

second order

Country：

China

Province：

fujian province

City：

Institution/hospital：

The 900th Hospital of Joint Logistics Support Force of Chinese People 's Liberation Army

Level of the institution：

tertiary level

Country：

China

Province：

Beijing

City：

Institution/hospital：

Beijing Changping Hospital of Integrated Traditional Chinese and Western Medicine

Level of the institution：

tertiary level

Country：

China

Province：

fujian province

City：

Institution/hospital：

china-japan friendship hospital

Level of the institution：

tertiary level

Country：

China

Province：

Beijing

City：

Institution/hospital：

Zhongguancun Hospital

Level of the institution：

grade 2 a

Outcomes：

Outcome：

TCM symptom grading quantitative score

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Health status evaluation of traditional Chinese medicine

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

evaluation of quality of life

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Adverse events related to moxibustion therapy

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

None

Tissue：

Fate of sample 

Others

Note：

Not yet recruiting

18
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)：

Subgroup dynamic and static parallel group design

Blinding：

IPD sharing：

Yes

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

October 2026 Open database: 1. China National Knowledge Network (https://www.cnki.net/); 2.PubMed (https://www.cnki.net/)

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

( 1 ) In this study the electronic case report form ( e-CRF ) was used for data collection and management. The researchers filled in the electronic case report form ( e-CRF ) to ensure that the data were recorded in a timely complete accurate and true manner. ( 2 ) The researcher logged in to the system for data entry and then the quality control system of the center logged in to check the original data for each data and questioned the result value inconsistent with the original medical record. The researcher checked the original data item by item for the query list and corrected it. To ensure that the data of the database is consistent with the data in the original record table. Any modification of the data after the completion of the markup needs to provide reasons for the modification and leave a trace of inspection.

Data Managemen Committee：

No

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

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