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

September 30, 2019 updated by: Cheng-Chung Wei, Chung Shan Medical University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan, 402
        • Chung Shan Medical University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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
Other Names:
  • Gan-Lu-Yin
Placebo Comparator: PLACEBO
TCM Placebo 6g in the morning TCM Placebo 8g in the evening for 12 weeks
Drug: PLACEBO
TCM Placebo 6g in the morning TCM Placebo 8g in the evening for 12 weeks

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chung Shan Medical University

Investigators

  • Principal Investigator: Wei C- C, M, Chung Shan Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2016

Primary Completion (Actual)

October 31, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

September 26, 2019

First Submitted That Met QC Criteria

September 30, 2019

First Posted (Actual)

October 1, 2019

Study Record Updates

Last Update Posted (Actual)

October 1, 2019

Last Update Submitted That Met QC Criteria

September 30, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS16051

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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