|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ITMCTR |
|
Last refreshed on:
|
20 February 2023 |
|
Main ID: |
ITMCTR2000003900 |
|
Date of registration:
|
2020-09-08 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Bushen Qingre Runzao decoction for primary Sjogren's syndrome: a randomized controlled trial
|
|
Scientific title:
|
Bushen Qingre Runzao decoction for primary Sjogren's syndrome: a randomized controlled trial |
|
Date of first enrolment:
|
2020-09-08 |
|
Target sample size:
|
Control group:48;Experimental group:48; |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://itmctr.ccebtcm.org.cn/en-US/Home/ProjectView?pid=59a3bd7b-640c-4135-98b8-c810d194307d |
|
Study type:
|
Interventional study |
|
Study design:
|
Parallel
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
China
| | | | | | | |
|
Contacts
|
|
Name:
|
Chen Jiaqi
|
|
Address:
|
11, East Road, Third Ring Road North, Chaoyang District, Beijing, China
100029
|
|
Telephone:
|
+86 15011251218 |
|
Email:
|
cjq-19971997@foxmail.com |
|
Affiliation:
|
Beijing University of Chinese Medicine |
|
|
Name:
|
Luo Jing
|
|
Address:
|
2 Yinghuayuan Street East, Chaoyang District, Beijing, China
100029
|
|
Telephone:
|
+86 15910598716 |
|
Email:
|
luojinggg@sina.com |
|
Affiliation:
|
China-Japan Friendship Hospital |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: 1. Age of 18 to 75 years;
2. Fulfill the 2016 American College of Rheumatology/European League Against Rheumatism classification criteria, with dry mouth or dry eyes;
3. Fulfill positive autoantibody (ANA or anti-SSA antibody or anti-SSB antibody or RF) and/or hyperimmunoglobulinemia or increased erythrocyte sedimentation rate;
4. Fulfill the Yin deficiency and dryness-heat syndrome;
5. Patients were informed and voluntarily signed informed consent.
Exclusion criteria: 1. Diagnosed with other connective tissue diseases;
2. Glucocorticoids or biological agents have been used within 3 months before enrollment;
3. Pregnancy, preparation for pregnancy or breastfeeding;
4. Patients with severe mental and neurological disorders;
5. Patients with severe disease of heart, brain, lung, liver, kidney, hematopoietic system, etc.;
6. Patients with definite visual field defects, ocular fundus lesions, and severe arrhythmias (atrial fibrillation, atrioventricular block, etc.);
7. Patients are participating in other drug trials.
Age minimum:
18
Age maximum:
75
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Primary Sjogren's syndrome
|
|
Intervention(s)
|
|
Control group:Hydroxychloroquine sulfate tablets 200ml bid po;Experimental group:Bushen Qingre Runzao Decoction 200ml bid po;
|
|
Primary Outcome(s)
|
|
Oral dryness VAS;
|
|
Secondary Outcome(s)
|
|
Pain VAS score;Eye dryness VAS score;C-reactive protein, CRP;ESSDAI score;SF-36 health survey;??Schirmer??;Erythrocyte sedimentation rate, ESR;Fatigue VAS score;Schirmer tests;Immunoglobulin (IgA, IgM, IgG)of serum;ESSPRI score;
|
|
Secondary ID(s)
|
|
ChiMCTR2000003900
|
|
ChiCTR2000037989
|
|
Source(s) of Monetary Support
|
|
Capital's Funds for Health Improvement and Research
|
|
Ethics review
|
Status: Approved
Approval date: 14/12/2020
Contact:
Chen Yanfen
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|