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

2019-10-07 08:56:50 | BioPortfolio

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.

Study Design

Conditions

Sjögren's Syndrome

Intervention

TCM (Gan-Lu-Yin)GLY, PLACEBO

Location

Chung Shan Medical University Hospital
Taichung
Taiwan
402

Status

Completed

Source

Chung Shan Medical University

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-07T08:56:50-0400

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