A Clinical Trial to Evaluate the Safety and Efficacy of Traditional Chinese Medicine in Sjögren's Syndrome.

Sjögren's Syndrome Clinical Trial

Official title:

A Double Blind, Randomized, Placebo Controlled Clinical Trial to Evaluate the Safety and Efficacy of Traditional Chinese Medicine in Sjögren's Syndrome.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04111341
• Other study ID #: CS16051
• Status: Completed
• Phase: Phase 2
• Start date: May 6, 2016
• Est. completion date: December 31, 2017

Study information

• Verified date: September 2019
• Source: Chung Shan Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate the efficacy and safety of traditional Chinese medicine in patients with Sjogren's syndrome.

Description:

This is 2 years' double blind, randomized, placebo-controlled clinical trial. Patients fulfilled the classification criteria of Sjogren syndrome will be recruited. Eligible subjects will be randomized on a 2:1 ratio to Traditional Chinese Medicine (TCM) granules or placebo for 12 weeks. The treatment group will receive a combination formula with traditional Chinese medicine, Gan-Lu-Yin in the morning and Jia-wei-Xiao-yao-San in the evening. Primary endpoint is the ESSPRI, European Sjogren Syndrome Patient Reported Outcome Index. Secondary endpoints include disease activity index (ESSDAI) , patient global assessment (PGA), VAS pain scale, Quality of Life by Short Form-36 (SF-36), fatigue scale and related serological markers. Thirty patients will be enrolled in the first year. After interim analysis at the end of first year, sample size will be recalculated base on the interim analysis results.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2017
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age =20 years old

• Written informed consent obtained

• Been diagnosed with the diagnostic criteria for Sjogren's syndrome (according to the 2002 European Classification Standard)

• The ESSPRI score of the patient of Sjogren's syndrome at least> 3

Exclusion Criteria:

• Have association disease about heart, lung, nerve or mental

• Pregnant or breastfeeding women

• Laboratory abnormality:

1. Serum creatinine =2.0 mg/dl

2. Male: Hb=9 g/dl;Female: Hb=8.5 g/dl

3. Neutrophil or lymphocyte<0.5 x 109/l

Related Conditions & MeSH terms

• Sjogren's Syndrome
• Sjögren's Syndrome
• Syndrome

Intervention

Drug:
• TCM (Gan-Lu-Yin)GLY
TCM Gan-Lu-Yin 6g in the morning TCM Jia-Wei-Xiao-Yao-San, Ye-Jiao-Teng, Suan-Zao-Ren 8g in the evening for 12 weeks
• PLACEBO
TCM Placebo 6g in the morning TCM Placebo 8g in the evening for 12 weeks

Locations

Country	Name	City	State
Taiwan	Chung Shan Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Chung Shan Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) at week 12	The investigators use ESSPRI to compared the difference between the week 12 and 0	week 0, week 12
Secondary	Change from baseline EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) at week 4	The investigators use ESSDAI to compared the difference between the the week 4 and 0	week 0, week 4
Secondary	Physicians Global Assessment to measure quality of life (PGA)	The investigators use PGA to compared the difference between the week 12 and 0, the week 8 and 0, the week 4 and 0	week 0, week 4, week 8, week 12
Secondary	Visual Analog Scale for pain (VAS)	The investigators use VAS to compared the difference between the week 12 and 0, the week 8 and 0, the week 4 and 0	week 0, week 4, week 8, week 12
Secondary	Quality of life by SF-36	The investigators use SF-36 to compared the difference between the week 12 and 0, the week 8 and 0, the week 4 and 0	week 0, week 4, week 8, week 12
Secondary	modified fatigue impact scale (MFI)	The investigators use MFI to compared the difference between the week 12 and 0, the week 8 and 0, the week 4 and 0	week 0, week 4, week 8, week 12
Secondary	Pittsburgh Sleep Quality Index (PSQI)	The investigators use PSQI to compared the difference between the week 12 and 0, the week 8 and 0, the week 4 and 0	week 0, week 4, week 8, week 12
Secondary	Body Constitution Questionnaire (BCQ)	The investigators use BCQ to compared the difference between the week 12 and 0, the week 8 and 0, the week 4 and 0	week 0, week 4, week 8, week 12
Secondary	Change from baseline EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) at week 8	The investigators use ESSDAI to compared the difference between the week 8 and 0	week 0, week 8