|
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:
|
ChiCTR |
|
Last refreshed on:
|
2 October 2017 |
|
Main ID: |
ChiCTR-IOR-17012802 |
|
Date of registration:
|
2017-09-26 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Synergy effects and health regulation effect of oxygen-ozone therapy on systemic lupus erythematosus (SLE)
|
|
Scientific title:
|
Synergy effects and health regulation effect of oxygen-ozone therapy on systemic lupus erythematosus (SLE) |
|
Date of first enrolment:
|
2017-09-26 |
|
Target sample size:
|
the Controled Group:30;the Treated Group:30; |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://www.chictr.org.cn/showproj.aspx?proj=21878 |
|
Study type:
|
Interventional study |
|
Study design:
|
Randomized parallel controlled trial
|
|
Phase:
|
Other
|
|
|
Countries of recruitment
|
|
China
| | | | | | | |
|
Contacts
|
|
Name:
|
Lili Pan
|
|
Address:
|
111 Dade Road, Yuexiu District, Guangzhou, Guangdong, China
|
|
Telephone:
|
+86 13660393050 |
|
Email:
|
a882panlili@126.com |
|
Affiliation:
|
Guangdong Provincial Hospital of Chinese Medicine |
|
|
Name:
|
Lili Pan
|
|
Address:
|
111 Dade Road, Yuexiu District, Guangzhou, Guangdong
|
|
Telephone:
|
+86 13660393050 |
|
Email:
|
a882panlili@126.com |
|
Affiliation:
|
Guangdong Provincial Hospital of Chinese Medicine |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: 1. SLE patients with a SLEDAI score of 5-14;
2. Patients with age between 18-65 years old;
3. Patienbs agree to sign the informed consent.
Exclusion criteria: 1. Patients do not meet the diagnosis of SLE;
2. Patients fail to sign the informed consent;
3. Patients with mean pulmonary arterial pressure>50mgHg, or non controllable infection, or organ failure;
4. Pregnant or lactating women;
5. Patients who are participating in another clinical trial;
6. Researchers of this study;
7. Unwilling to comply with treatment or assessment regimen;
8. Unable to comply with treatment or assessment regimen.
Age minimum:
18
Age maximum:
65
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
systemic lupus erythematosus (SLE)
|
|
Intervention(s)
|
|
the Controled Group:basic oral therapy;the Treated Group:basic oral therapy + Autologous blood transfusion with oxygen-ozone + acupoint injection with oxygen-ozone on ST 36;
|
|
Primary Outcome(s)
|
|
SLEDAI score;
|
|
Secondary Outcome(s)
|
|
autoimmune antibody tests;ESR;CRP;SF-36;
|
|
Source(s) of Monetary Support
|
|
Traditional Chinese Medicine Bureau of Gaungdong Province
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|