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

Phase 2

Completed

• Conditions: Sjögren's Syndrome
• Interventions: Drug: TCM (Gan-Lu-Yin)GLY; Drug: PLACEBO

• Registration Number: NCT04111341
• Lead Sponsor: Chung Shan Medical University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2016-05-06
• Primary Completion: 2017-10-31
• Study Completion: 2017-12-31
• Status Verified: 2019-09
• Study First Submitted: 2019-09-26
• Study First Submitted QC: 2019-09-30
• Last Update Submitted: 2019-09-30
• Study First Posted: 2019-10-01
• Last Update Posted: 2019-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TCM Gan-Lu-Yin (GLY)	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	PLACEBO	TCM Placebo 6g in the morning TCM Placebo 8g in the evening for 12 weeks

Primary Outcome Measures

Name	Time	Method
Change from baseline EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) at week 12	week 0, week 12	The investigators use ESSPRI to compared the difference between the week 12 and 0

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chung Shan Medical University Hospital; 🇨🇳 Taichung, Taiwan