Clinical observation on treatment of proteinuria in stage i-ii of chronic kidney disease by acupoint selection based on syndrome differentiation combined with classical prescriptions

Registration number:

ITMCTR2100004883

Date of Last Refreshed on:

2021-05-26

Date of Registration:

2021-05-26

Registration Status:

Prospective registration

Public title:

Clinical observation on treatment of proteinuria in stage i-ii of chronic kidney disease by acupoint selection based on syndrome differentiation combined with classical prescriptions

English Acronym:

Scientific title:

Clinical observation on treatment of proteinuria in stage i-ii of chronic kidney disease by acupoint selection based on syndrome differentiation combined with classical prescriptions

Scientific title acronym:

Study subject ID:

The registration number of the Partner Registry or other register:

ChiCTR2100046666 ; ChiMCTR2100004883

Applicant:

Wang Lifan

Study leader:

Wang Lifan

Applicant telephone:

+86 13339302677

Study leader's telephone:

+86 13339302677

Applicant Fax:

Study leader's fax:

Applicant E-mail:

wlf4648374@163.com

Study leader's E-mail:

wlf4648374@163.com

Study leader's website(voluntary supply):

Study leader's website
(voluntary supply):

Applicant address:

72 Xiang'an Street, Xiangfang District, Harbin, Heilongjiang

Study leader's address:

72 Xiang'an Street, Xiangfang District, Harbin, Heilongjiang

Applicant postcode:

150036

Study leader's postcode:

150036

Applicant's institution:

Heilongjiang Academy of Traditional Chinese Medicine

Approved by ethic committee:

Approved No. of ethic committee:

2019-007-01

Approved file of Ethical Committee:

View

Name of the ethic committee:

Ethics Committee of Heilongjiang Academy of Traditional Chinese Medicine

Date of approved by ethic committee:

2019/11/27 0:00:00

Contact Name of the ethic committee:

Li Xin

Contact Address of the ethic committee:

72 Xiang'an Street, Xiangfang District, Harbin, Heilongjiang

Contact phone of the ethic committee:

+86 45155167342

Contact email of the ethic committee:

zyykxyll@163.com

Primary sponsor:

Heilongjiangl Academy of Traditional Chinese Medicine

Primary sponsor's address:

72 Xiang'an Street, Xiangfang District, Harbin, Heilongjiang

Secondary sponsor:

Country:

China

Province:

Heilongjiang

City:

Harbin

Institution
hospital:

Heilongjiangl Academy of Traditional Chinese Medicine

Address:

72 Xiang'an Street, Xiangfang District

Source(s) of funding:

Heilongjiang applied technology research and development program project (Heilongjiang Provincial Department of science and Technology)

Target disease:

CKD(stageI-II)

Target disease code:

Study type:

Interventional study

Study design:

Non randomized control

Study phase:

Pilot clinical trial

Objectives of Study:

Main purpose: A relatively complete clinical diagnosis and treatment plan for CKD(stage i-ii) proteinuria with prominent traditional Chinese medicine characteristics and easy to promote was formed through the summary of this study.

Description for medicine or protocol of treatment in detail:

Inclusion criteria

1. Aged 18 to 65 years; 2. Meet CKD1-2; 3. Infection, high blood pressure, blood pressure control in < 140/90 MMHG) to effectively control; 4. 24 hours urinary protein quantitative 1-3 g/24 h; 5. In line with the diagnostic criteria of traditional Chinese medicine (TCM) and western medicine symptomatic diagnosis standards.

Exclusion criteria:

1. During pregnancy and lactation women; 2. The rectum serious illness or surgery, the impact of drug use or absorption; 3. For treatment of intolerance; 4. Those with combined severe primary diseases such as hematopoietic system and malignancy; 5. For nearly three months used hormone and ARB and ACEI or immunosuppressive doses; 6. Unable to partner; 7. Have other severe acute or chronic infection can cause chronic kidney disease (CKD) is aggravating factor has not been effective control or highly stable.

Study execute time:

From 2019-09-01

To      2022-10-31

Recruiting time:

From 2021-06-01

To      2022-05-31

Interventions:

37

Group:

Experimental group1

Sample size:

Intervention:

spleen and kidney qi deficiency group with Chinese medicine decoction combined with acupuncture and acupoint application

Intervention code:

37

Group:

Control group

Sample size:

Intervention:

Kosuya

Intervention code:

37

Group:

Experimental group2

Sample size:

Intervention:

deficiency of both qi and yin with Chinese medicine decoction combined with acupuncture and acupoint application

Intervention code:

Total sample size : 111

Countries of recruitment
and research settings:

Country:

China

Province:

Heilongjiang

City:

Harbin

Institution/hospital:

Heilongjiang Academy of Traditional Chinese Medicine

Level of the institution:

Tertiary A

Outcomes:

Outcome:

Stool examination

Type:

Adverse events

Measure time point of outcome:

0 month, 3 months

Measure method:

Outcome:

Electrolyte

Type:

Secondary indicator

Measure time point of outcome:

0 month, 3 months

Measure method:

Outcome:

Kidney function

Type:

Secondary indicator

Measure time point of outcome:

0 month, 3 months

Measure method:

Outcome:

Urine routine

Type:

Primary indicator

Measure time point of outcome:

0 weeks, 4 weeks, 8 weeks, 12 weeks

Measure method:

Outcome:

Urine protein quantification

Type:

Primary indicator

Measure time point of outcome:

0 weeks, 4 weeks, 8 weeks, 12 weeks

Measure method:

Outcome:

Electrocardiogram

Type:

Adverse events

Measure time point of outcome:

0 month, 3 months

Measure method:

Outcome:

Blood lipids

Type:

Secondary indicator

Measure time point of outcome:

0 month, 3 months

Measure method:

Outcome:

liver function

Type:

Secondary indicator

Measure time point of outcome:

0 month, 3 months

Measure method:

Outcome:

Traditional chinese medicine symptom score

Type:

Secondary indicator

Measure time point of outcome:

0 month, 1 months, 2 months, 3 months

Measure method:

Collecting sample(s)
from participants:

Sample Name:

night soil

Tissue:

Fate of sample 

Destruction after use

Note:

Sample Name:

blood

Tissue:

Fate of sample 

Destruction after use

Note:

Sample Name:

urine

Tissue:

Fate of sample 

Destruction after use

Note:

Recruiting

18
Min age years
65
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:

Open-label

IPD sharing:

Yes

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

Collection of case record sheets and electronic forms, which will be published after the end of the project in 2022

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

Case Record Form

Data Managemen Committee:

Not yet

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

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above