Clinical evaluation of the application of Langchuangjing granule in the treatment of systemic lupus erythematosus

• Register: ChiCTR
• Last refreshed on: 14 January 2019
• Main ID: ChiCTR1800020286
• Date of registration: 2018-12-22
• Prospective Registration: Yes
• Primary sponsor: Nanjing University of Chinese Medicine Affiliated Hospital
• Public title: Clinical evaluation of the application of Langchuangjing granule in the treatment of systemic lupus erythematosus
• Scientific title: Efficacy and safety of Langchuangjing granule in the treatment of systemic lupus erythematosus: a clinical evaluation
• Date of first enrolment: 2019-02-01
• Target sample size: Group 2:40;Group 1:20;
• Recruitment status: Pending
• URL: http://www.chictr.org.cn/showproj.aspx?proj=31101
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: I (Phase I study)

Countries of recruitment

China

Contacts

• Name: Guo Feng
• Affiliation: Jiangsu Province Hospital of TCM

• Name: Guo Feng
• Affiliation: Jiangsu Province Hospital of TCM

Key inclusion & exclusion criteria

Inclusion criteria: 1.Meet the diagnostic criteria of SLE and the syndrome differentiation standard of TCM kidney deficiency and phlegm syndrome.
2.The age is between 18 and 65 years old, regardless of gender.
3.Patients who have used or are using hormone therapy.
4.Informed consent, volunteering to be tested. The process of obtaining informed consent should be in accordance with GCP regulations.
Exclusion criteria: 1.Patients have combined with serious diseases such as infections and tumors.
2.There are other rheumatisms such as rheumatoid arthritis, scleroderma, polymyositis, and Sjogren's syndrome.
3.The condition is critical and it is difficult to make a definitive assessment of the effectiveness of this trial.
4.Pregnant, lactating women.
5.Persons with adequate informed consent cannot be given due to intellectual or behavioral disorders.
6.Suspected or indeed have a history of alcohol and drug abuse.
7.According to the judgment of the investigator, other lesions that have the possibility of reducing the enrollment or complicating the enrollment, such as frequent changes in the working environment, are likely to cause loss of follow-up.
8.Allergies, such as those who have a history of allergies to two or more drugs or foods; or those who are known to be allergic to the ingredients.
9.Patients who are participating in other drug clinical trials.

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Group 2:Langchuangjing granule + Prednisone acetate tablets, hydroxychloroquine and other Western medicines for 12 weeks.;Group 1:Prednisone acetate tablets, hydroxychloroquine and other Western medicines for 12 weeks.;

Primary Outcome(s)

temperature;Blood Pressure;SLEDAI;blood sugar;metabolomics;proteomics;

Source(s) of Monetary Support

Nanjing University of Chinese Medicine Affiliated Hospital

Ethics review

Status: Approved
Approval date: 30/07/2018
Contact:

Wu Jing

[phone]