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The Real-World Cohort Study of Diagnosis and Treatment Protocols for Chronic Kidney Disease Stages 3-5 Based on Traditional Chinese Medicine Advantages

Registration number：

ITMCTR2025000394

Date of Last Refreshed on：

2025-02-24

Date of Registration：

2025-02-24

Registration Status：

Prospective registration

Public title：

The Real-World Cohort Study of Diagnosis and Treatment Protocols for Chronic Kidney Disease Stages 3-5 Based on Traditional Chinese Medicine Advantages

English Acronym：

Scientific title：

The Real-World Cohort Study of Diagnosis and Treatment Protocols for Chronic Kidney Disease Stages 3-5 Based on Traditional Chinese Medicine Advantages

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Zhao Jing

Study leader：

Sun Wei

Applicant telephone：

13951850782

Study leader's telephone：

+86 13505199 810

Applicant Fax：

Study leader's fax：

Applicant E-mail：

13951850782@163.com

Study leader's E-mail：

13505199810@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

No. 155 Hanzhong Road Nanjing Jiangsu Province China

Study leader's address：

No. 155 Hanzhong Road Nanjing Jiangsu Province China

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Jiangsu Provincial Hospital of Traditional Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

2023NL-178-03

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of the Affiliated Hospital of Nanjing University of Traditional Chinese Medicine (Jiangsu Provincial Hospital of Traditional Chinese Medicine)

Date of approved by ethic committee：

2023/8/3 0:00:00

Contact Name of the ethic committee：

Wang Mao

Contact Address of the ethic committee：

Jiangsu Provincial Hospital of Traditional Chinese Medicine

Contact phone of the ethic committee：

+86 25 8656 0515

Contact email of the ethic committee：

13951850782@163.com

Primary sponsor：

Jiangsu Provincial Hospital of Traditional Chinese Medicine

Primary sponsor's address：

No. 155 Hanzhong Road Nanjing Jiangsu Province China

Secondary sponsor：

Country：

China

Province：

Jiangsu Province

City：

Institution
hospital：

Jiangsu Provincial Hospital of Traditional Chinese Medicine

Address：

No. 155 Hanzhong Road Nanjing Jiangsu Province China

Source(s) of funding：

Jiangsu Provincial Administration of Traditional Chinese Medicine

Target disease：

chronic kidney disease

Target disease code：

Study type：

Observational study

Study design：

Cohort study

Study phase：

Others

Objectives of Study：

Evaluate the effectiveness and safety of the diagnosis and treatment protocols for Chronic Kidney Disease Stages 3-5 based on Traditional Chinese Medicine advantages developed by the Jiangsu Provincial Administration of Traditional Chinese Medicine and promote their implementation within provincial institutions.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

①Patients must meet the clinical staging criteria for chronic kidney disease as defined by the American KDIGO guidelines with a GFR < 60 ml/min/1.73m² and be non-dialysis patients; ②Traditional Chinese Medicine syndromes include Kidney Deficiency and Damp-Heat for CKD Stage 3 Kidney Deficiency and Damp-Stasis for CKD Stage 4 and Kidney Deficiency and Stasis-Toxin Syndrome for CKD Stage 5; ③Age between 18 and 80 years; ④Voluntary participation in the study and signing of an informed consent form.

Exclusion criteria：

①Pregnant or breastfeeding women; ②Those with severe underlying primary diseases such as serious heart brain liver or hematological conditions individuals with allergic constitutions or those allergic to multiple medications; ③Individuals unable to cooperate such as patients with psychiatric disorders.

Study execute time：

From 2023-01-01

To      2025-12-31

Recruiting time：

From 2025-02-25

To      2025-12-20

Interventions：

500

Group：

Expose Queue

Sample size：

Intervention：

Receive treatment according to the diagnosis and treatment protocol for Chronic Kidney Disease Stages 3-5 based on Traditional Chinese Medicine advantages, as published by the Jiangsu Provincial Administration of Traditional Chinese Medicine in 2022.

Intervention code：

500

Group：

non-exposed queue

Sample size：

Intervention：

Receive conventional standard treatment as recommended by Western medicine guidelines.

Intervention code：

Total sample size ： 1000

Countries of recruitment
and research settings：

Country：

China

Province：

Jiangsu Province

City：

Institution/hospital：

Jiangsu Provincial Hospital of Traditional Chinese Medicine

Level of the institution：

Tertiary Tertiary A

Country：

China

Province：

Jiangsu Province

City：

Institution/hospital：

Gaochun Hospital of Traditional Chinese Medicine

Level of the institution：

Secondary Secondary A

Country：

China

Province：

Jiangsu Province

City：

Institution/hospital：

Changshu Hospital of Traditional Chinese Medicine

Level of the institution：

Tertiary Tertiary B

Country：

China

Province：

Jiangsu Province

City：

Institution/hospital：

Nantong Hospital of Traditional Chinese Medicine

Level of the institution：

Tertiary Tertiary A

Country：

China

Province：

Jiangsu Province

City：

Institution/hospital：

Suzhou Hospital of Traditional Chinese Medicine

Level of the institution：

Tertiary Tertiary A

Outcomes：

Outcome：

Liver function

Type：

Additional indicator

Measure time point of outcome：

Measure method：

Outcome：

Serum urea nitrogen

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Serum creatinine

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Electrolytes

Type：

Additional indicator

Measure time point of outcome：

Measure method：

Outcome：

Urine Albumin Creatinine Ratio

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Estimating glomerular filtration rate

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Routine blood test

Type：

Additional indicator

Measure time point of outcome：

Measure method：

Outcome：

Electrolytes

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Quality of life score

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

Blood

Tissue：

Fate of sample 

Destruction after use

Note：

Sample Name：

Urine

Tissue：

Fate of sample 

Destruction after use

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)：

None

Blinding：

IPD sharing：

No

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

No

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

The CRF form has undergone ethical review and a specialized EDC system has been developed.

Data Managemen Committee：

Not yet

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

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