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A multicenter clinical study on the characteristics and evolution law of TCM Constitution, Meridians and early intervention in the pre PD population

Registration number：

ITMCTR2200006458

Date of Last Refreshed on：

2022-08-09

Date of Registration：

2022-08-09

Registration Status：

Prospective registration

Public title：

A multicenter clinical study on the characteristics and evolution law of TCM Constitution, Meridians and early intervention in the pre PD population

English Acronym：

Scientific title：

A multicenter clinical study on the characteristics and evolution law of TCM Constitution, Meridians and early intervention in the pre PD population

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

ChiCTR2200062495 ; ChiMCTR2200006458

Applicant：

Yang Ning

Study leader：

Liu Weiguo

Applicant telephone：

13776698638

Study leader's telephone：

13914725569

Applicant Fax：

Study leader's fax：

Applicant E-mail：

yaangningtaozi@163.com

Study leader's E-mail：

liuweiguo1111@sina.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

264 Guangzhou road, Gulou District, Nanjing, Jiangsu

Study leader's address：

264 Guangzhou road, Gulou District, Nanjing, Jiangsu

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Brain Hospital Affiliated to Nanjing Medical University（Nanjing Brain Hospital ）

Approved by ethic committee：

Approved No. of ethic committee：

2021-KY120-01

Approved file of Ethical Committee：

View

Name of the ethic committee：

Medical ethics committee of Nanjing Brain Hospital

Date of approved by ethic committee：

1990/1/1 0:00:00

Contact Name of the ethic committee：

Contact Address of the ethic committee：

Contact phone of the ethic committee：

Contact email of the ethic committee：

Primary sponsor：

Brain Hospital Affiliated to Nanjing Medical University（Nanjing Brain Hospital）

Primary sponsor's address：

264 Guangzhou road, Gulou District, Nanjing, Jiangsu

Secondary sponsor：

Country：

China

Province：

Jiangsu

City：

Institution
hospital：

Jiangsu Administration of traditional Chinese Medicine

Address：

No. 42, Zhongyang Road, Nanjing

Source(s) of funding：

Special key project of science and technology development of Jiangsu Administration of traditional Chinese medicine in 2020

Target disease：

Parkinson's disease

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

New Treatment Measure Clinical Study

Objectives of Study：

(1) To study the constitution, meridian characteristics and transformation law of high-risk groups in prodrome stage of PD; (2) To study the effect and mechanism of Shudi Pingzhan Granule on delaying the transformation from prodrome to PD.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

① Age ≥ 60, male or female; ② It meets the diagnostic criteria for PD prodrome formulated by the international movement disorders society in 2015; ③ Updrs- Ⅲ score ≥ 4 points and ≤ 10 points; ④ Sign the informed consent form; ⑤ There are no serious diseases in the heart, brain, kidney and other important organ systems.

Exclusion criteria：

① Patients with severe cognitive impairment or mental symptoms; ② Patients with severe liver and kidney insufficiency; ③ Patients who are participating in other clinical studies or have participated in other clinical studies within the previous 30 days; ④ Patients unable to cooperate with the investigation; ⑤ Patients who have been diagnosed with PD disease or PD syndrome.

Study execute time：

From 2021-01-01

To      2024-12-31

Recruiting time：

From 2022-08-01

To      2024-06-30

Interventions：

46

Group：

Treatment group

Sample size：

Intervention：

Shudi Pingchan granule

Intervention code：

46

Group：

control group

Sample size：

Intervention：

Shudi Pingchan granule simulant

Intervention code：

Total sample size ： 92

Countries of recruitment
and research settings：

Country：

China

Province：

Jiangsu

City：

Institution/hospital：

Lianyungang Second People's Hospital

Level of the institution：

Tertiary A Hospital

Country：

China

Province：

Jiangsu

City：

Institution/hospital：

Nanjing Hospital of traditional Chinese Medicine

Level of the institution：

Tertiary A Hospital

Country：

China

Province：

Jiangsu

City：

Institution/hospital：

Brain Hospital Affiliated to Nanjing Medical University（Nanjing Brain Hospital ）

Level of the institution：

Tertiary A Hospital

Country：

China

Province：

Jiangsu

City：

Institution/hospital：

Jiangsu integrated traditional Chinese and Western Medicine Hospital

Level of the institution：

Tertiary A Hospital

Country：

China

Province：

Jiangsu

City：

Institution/hospital：

Affiliated Hospital of Xuzhou Medical University

Level of the institution：

Tertiary A Hospital

Outcomes：

Outcome：

PDSS-2

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

MMSE

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

HAMA

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

NMSS

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

RBDQ--HK

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

UPDRS

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

MOCA

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

SCOPA-Cog

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

经络能量数值

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

UPDRS

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

constitution in chinese medicine questionnaire

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

HAMD

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

α-Syn

Tissue：

blood

Fate of sample 

Destruction after use

Note：

Sample Name：

il-6

Tissue：

blood

Fate of sample 

Destruction after use

Note：

Sample Name：

il-1β

Tissue：

blood

Fate of sample 

Destruction after use

Note：

Sample Name：

il-2

Tissue：

blood

Fate of sample 

Destruction after use

Note：

Not yet recruiting

Min age years
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

Computer software

Blinding：

IPD sharing：

No

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

Unshare

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

CRF

Data Managemen Committee：

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

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