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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT04111341
• Date of registration: 26/09/2019
• Prospective Registration: No
• Primary sponsor: Chung Shan Medical University
• Public title: A Clinical Trial to Evaluate the Safety and Efficacy of Traditional Chinese Medicine in Sjögren's Syndrome.
• Scientific title: A Double Blind, Randomized, Placebo Controlled Clinical Trial to Evaluate the Safety and Efficacy of Traditional Chinese Medicine in Sjögren's Syndrome.
• Date of first enrolment: May 6, 2016
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT04111341
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Countries of recruitment

Taiwan

Contacts

• Name: Wei C- C, M
• Affiliation: Chung Shan Medical University

Key inclusion & exclusion 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



Age minimum: 20 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Sjögren's Syndrome

Intervention(s)

Drug: PLACEBO

Drug: TCM (Gan-Lu-Yin)GLY

Primary Outcome(s)

Change from baseline EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) at week 12 [Time Frame: week 0, week 12]

Secondary Outcome(s)

Visual Analog Scale for pain (VAS) [Time Frame: week 0, week 4, week 8, week 12]

Body Constitution Questionnaire (BCQ) [Time Frame: week 0, week 4, week 8, week 12]

Change from baseline EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) at week 4 [Time Frame: week 0, week 4]

Change from baseline EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) at week 8 [Time Frame: week 0, week 8]

Pittsburgh Sleep Quality Index (PSQI) [Time Frame: week 0, week 4, week 8, week 12]

Quality of life by SF-36 [Time Frame: week 0, week 4, week 8, week 12]

Physicians Global Assessment to measure quality of life (PGA) [Time Frame: week 0, week 4, week 8, week 12]

modified fatigue impact scale (MFI) [Time Frame: week 0, week 4, week 8, week 12]

Secondary ID(s)

CS16051

Source(s) of Monetary Support

Please refer to primary and secondary sponsors