A Randomized Double-blind Controlled Study on the Effect of Different Compatibility Ratios of Peony and Glycyrrhizae Herbs on the Clinical Efficacy of Jiedu Tongluo Shengjin Granules

• Register: ChiCTR
• Last refreshed on: 5 October 2020
• Main ID: ChiCTR2000037057
• Date of registration: 2020-08-26
• Prospective Registration: Yes
• Primary sponsor: Yueyang Integrated Traditional Chinese and Western Medicine Hospital affiliated to Shanghai University of Traditional Chinese Medicine
• Public title: A Randomized Double-blind Controlled Study on the Effect of Different Compatibility Ratios of Peony and Glycyrrhizae Herbs on the Clinical Efficacy of Jiedu Tongluo Shengjin Granules
• Scientific title: A Randomized Double-blind Controlled Study on the Effect of Different Compatibility Ratios of Peony and Glycyrrhizae Herbs on the Clinical Efficacy of Jiedu Tongluo Shengjin Granules
• Date of first enrolment: 2021-01-01
• Target sample size: The first group :30; The second group:30; The third group:30;The fourth group:30;
• Recruitment status: Pending
• URL: http://www.chictr.org.cn/showproj.aspx?proj=60186
• Study type: Interventional study
• Study design: Parallel
• Phase: 0

Countries of recruitment

China

Contacts

• Name: Dan Wang
• Affiliation: Yueyang Integrated Traditional Chinese and Western Medicine Hospital affiliated to Shanghai University of Traditional Chinese Medicine

• Name: Dan Wang
• Affiliation: Yueyang Integrated Traditional Chinese and Western Medicine Hospital affiliated to Shanghai University of Traditional Chinese Medicine

Key inclusion & exclusion criteria

Inclusion criteria: 1. SS patients who meet the above diagnostic criteria of traditional Chinese and Western medicine.
2. Patients with moderate activity (essdai score 4-6).
3. Age of subjects: 18-65 years old.
4. Patients who have not used traditional Chinese medicine in the past, or have been interrupted for more than 2 months.
5. Women of childbearing age agreed to take effective contraceptive measures during the trial.
6. Patients who voluntarily sign informed consent and comply with the requirements of the study protocol.
Exclusion criteria: 1. Patients with severe or uncontrolled cardiovascular, liver, kidney, brain and hematopoietic system.
2. Patients with other connective tissue diseases, drug-induced lupus syndrome, tuberculosis and psychosis.
3. Pregnant or lactating women.
4. Patients with ALT or ast more than twice the upper limit of normal value, or total bilirubin greater than the upper limit of normal value.
5. Patients with allergic constitution.

Age minimum: 18
Age maximum: 65
Gender: Both

Health Condition(s) or Problem(s) studied

Sjogren syndrome

Intervention(s)

The first group : The dosage of peony and licorice in Jiedu Tongluo Shengjin Granules is: 12g of Radix Paeoniae Alba and 6g of raw licorice (2:1) ; The second group:The dosage of Peony and Glycyrrhiza in Jiedu Tongluo Shengjin Granules is: 18g of Radix Paeoniae and 6g of licorice (3 :1); The third group:The dosage of peony and licorice in Jiedu Tongluo Shengjin Granules is: Radix Paeoniae Alba 30g and raw licorice 6g (5:1);The fourth group:One-tenth of placebo detoxification Tongluo Shengjin granules (white peony 12g licorice 6g);

Primary Outcome(s)

Saliva flow rate;Schirmer's test;Corneal fluorescent stain;Tear film rupture time;ESR;Serum IgG;RF;CRP;Serum ß2 microglobulin;

Secondary Outcome(s)

C3;C4;Hormone withdrawal;Drug side effects;Number of relapses, degree of progress;

Secondary ID(s)

ChiMCTR2000003741

Source(s) of Monetary Support

Shenkang three-year Chinese medicine action plan subsidy

Ethics review

Status: Not approved
Approval date: 26/08/2013
Contact: