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Clinical study on the modified Yiguanjian in the treatment of Sjögren's syndrome with yin deficiency and blood dryness

Registration number：

ITMCTR2024000485

Date of Last Refreshed on：

2024-09-26

Date of Registration：

2024-09-26

Registration Status：

Prospective registration

Public title：

Clinical study on the modified Yiguanjian in the treatment of Sjögren's syndrome with yin deficiency and blood dryness

English Acronym：

Scientific title：

Clinical study on the modified Yiguanjian in the treatment of Sjögren's syndrome with yin deficiency and blood dryness

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

zhong bing

Study leader：

zhong bing

Applicant telephone：

18203063388

Study leader's telephone：

18203063388

Applicant Fax：

Study leader's fax：

Applicant E-mail：

dune_zhong@163.com

Study leader's E-mail：

dune_zhong@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

No. 30 Gaotanyan Street, Shapingba District, Chongqing

Study leader's address：

No. 30 Gaotanyan Street, Shapingba District, Chongqing

Applicant postcode：

400038

Study leader's postcode：

400038

Applicant's institution：

The First Affiliated Hospital, Army Medical University

Approved by ethic committee：

Approved No. of ethic committee：

KY2024083

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of the First Affiliated Hospital of Army Medical University, PLA

Date of approved by ethic committee：

2024/6/27 0:00:00

Contact Name of the ethic committee：

Jiang lucan

Contact Address of the ethic committee：

No. 30 Gaotanyan Street, Shapingba District, Chongqing

Contact phone of the ethic committee：

023-68754035

Contact email of the ethic committee：

xnyyec@163.com

Primary sponsor：

The First Affiliated Hospital, Army Medical University

Primary sponsor's address：

No. 30 Gaotanyan Street, Shapingba District, Chongqing

Secondary sponsor：

Country：

China

Province：

Chongqing

City：

Shapingba district

Institution
hospital：

The First Affiliated Hospital, Army Medical University

Address：

重庆市沙坪坝区高滩岩正街30号

Source(s) of funding：

Chongqing Science and Health Joint Project, 2023MSXM167, 2024ZYZD010

Target disease：

primary sjogren's syndrome

Target disease code：

Study type：

Interventional study

Study design：

Non randomized control

Study phase：

Others

Objectives of Study：

Non-randomized control study was conducted to verify the efficacy, safety and preliminary mechanism of action of modified Yiguanjian on Sjögren's syndrome with yin deficiency and blood dryness.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

1) Age 18-75 years old; 2) Meet the 2002 AECG or 2016 ACR/EUALR classification criteria of Sjögren's syndrome and the diagnostic criteria of yin deficiency and blood dryness syndrome in traditional Chinese medicine; 3) The patient agrees and signs the informed consent, and can implement the treatment plan and follow-up as required.

Exclusion criteria：

1) Patients with secondary SS; 2) Patients with severe systemic organ damage secondary to Sjögren's syndrome, such as severe thrombocytopenia, lymphoma, renal tubular acidosis, nephrogenic diabetes insipidus, neuromyelitis optica, interstitial lung disease or recent uncured lung infections; 3) Combined with serious diseases such as severe diabetes, severe hypertension, cardiovascular and cerebrovascular diseases, history of previous hematologic diseases, etc.; 4) Those who have contraindications to hydroxychloroquine treatment or are allergic to or cannot tolerate the drugs in this prescription; 5) Patients with comorbid glaucoma, fundus disease, ocular trauma or other active ocular surface disease; 6) Inability to adhere to the implementation of treatment and follow-up according to the requirements of the trial; 7) Presence of other serious diseases in the body or oral administration of drugs that may affect the results of the test; 8) Pregnant or lactating women, or those who have recent reproductive needs; 9) Those with mental illness and intellectual and speech disabilities; 10) Those who are participating in clinical trials of other drugs, or have completed clinical trials of other drugs for less than 3 months.

Study execute time：

From 2024-07-01

To      2026-06-30

Recruiting time：

From 2024-10-01

To      2026-03-31

Interventions：

40

Group：

Test group

Sample size：

Intervention：

Modified Yiguanjian, one sack/time,bid + hydroxychloroquine 5～6mg/kg/d

Intervention code：

40

Group：

Control group

Sample size：

Intervention：

Hydroxychloroquine 5～6mg/kg/d

Intervention code：

Total sample size ： 80

Countries of recruitment
and research settings：

Country：

China

Province：

Chongqing

City：

Shapingba District

Institution/hospital：

The First Affiliated Hospital, Army Medical University

Level of the institution：

Grade III Class A Hospital

Outcomes：

Outcome：

Sjögren’s Tool for Assessing Response

Type：

Secondary indicator

Measure time point of outcome：

12 weeks

Measure method：

Outcome：

general score for disease activity

Type：

Primary indicator

Measure time point of outcome：

0, 4, 8, 12 weeks

Measure method：

Outcome：

Safety indicators (liver and kidney function, hematuria routine)

Type：

Adverse events

Measure time point of outcome：

0, 4, 8, 12 weeks

Measure method：

Outcome：

Laboratory indicators（IgA, IgG, IgM, C3, C4, SSA, SSB, RF, et al）

Type：

Secondary indicator

Measure time point of outcome：

0, 12 weeks

Measure method：

Outcome：

TCM syndrome score

Type：

Primary indicator

Measure time point of outcome：

0, 4, 8, 12 weeks

Measure method：

Outcome：

first part of score for xerostomia and xerophthalmia

Type：

Secondary indicator

Measure time point of outcome：

0, 12 weeks

Measure method：

Outcome：

second part of score for xerostomia and xerophthalmia

Type：

Secondary indicator

Measure time point of outcome：

0, 4, 8, 12 weeks

Measure method：

Schirmer test, unstimulated whole salivary flows

Collecting sample(s)
from participants：

Sample Name：

Blood

Tissue：

Fate of sample 

Destruction after use

Note：

Not yet recruiting

18
Min age years
75
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

NO

Blinding：

IPD sharing：

Yes

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

After June 2027, the investigator can be contacted by email, dune_zhong@163.com

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

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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