Clinical trial NCT04111341: A Clinical Trial to Evaluate the Safety and Efficacy of Traditional Chinese Medicine in Sjögren's Syndrome.
Official title: A Double Blind, Randomized, Placebo Controlled Clinical Trial to Evaluate the Safety and Efficacy of Traditional Chinese Medicine in Sjögren's Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sjögren's Syndrome
Keywords: Sjögren's syndrome
Traditional Chinese Medicine
Herbs
Clinical trial
Gan-Lu-Yin
Jia-wei-Xiao-yao-San
Ye-Jiao-Teng
Suan-Zao-Ren
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) at week 12
timeFrame: week 0, week 12
Secondary outcomes:
measure: Change from baseline EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) at week 4
timeFrame: week 0, week 4
measure: Physicians Global Assessment to measure quality of life (PGA)
timeFrame: week 0, week 4, week 8, week 12
measure: Visual Analog Scale for pain (VAS)
timeFrame: week 0, week 4, week 8, week 12
measure: Quality of life by SF-36
timeFrame: week 0, week 4, week 8, week 12
measure: modified fatigue impact scale (MFI)
timeFrame: week 0, week 4, week 8, week 12
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: week 0, week 4, week 8, week 12
measure: Body Constitution Questionnaire (BCQ)
timeFrame: week 0, week 4, week 8, week 12
measure: Change from baseline EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) at week 8
timeFrame: week 0, week 8
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
Study officials:
affiliation: Chung Shan Medical University
name: Wei C- C, M
role: PRINCIPAL_INVESTIGATOR
References: