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NCT Number: NCT04111341

A 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.

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Key information

Conditions

Sjögren's Syndrome Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Dry Eye Syndromes Eye Diseases Immune System Diseases Joint Diseases Lacrimal Apparatus Diseases Mouth Diseases Musculoskeletal Diseases Rheumatic Diseases Salivary Gland Diseases Sjogren's Syndrome Skin and Connective Tissue Diseases Stomatognathic Diseases Xerostomia

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chung Shan Medical University Hospital

Taichung, 402, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Serum creatinine ≥2.0 mg/dl
  • Male: Hb≤9 g/dl;Female: Hb≤8.5 g/dl
  • Neutrophil or lymphocyte<0.5 x 109/l

Treatment and study plan

TCM (Gan-Lu-Yin)GLY

Drug

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

Drug

TCM Placebo 6g in the morning TCM Placebo 8g in the evening for 12 weeks

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

Chung Shan Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 1, 2019
Registry last updated
Oct 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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