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

NCT04111341 | Completed Phase 2 DMC

• 1 other identifier: CS16051
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Outcome Measures

Primary Outcomes (1)

• Change from baseline EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) at week 12

  The investigators use ESSPRI to compared the difference between the week 12 and 0

  week 0, week 12

Secondary Outcomes (8)

• Change from baseline EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) at week 4

  week 0, week 4

• Physicians Global Assessment to measure quality of life (PGA)

  week 0, week 4, week 8, week 12

• Visual Analog Scale for pain (VAS)

  week 0, week 4, week 8, week 12

• Quality of life by SF-36

  week 0, week 4, week 8, week 12

• modified fatigue impact scale (MFI)

  week 0, week 4, week 8, week 12

Study Arms (2)

TCM Gan-Lu-Yin (GLY)

EXPERIMENTAL

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

PLACEBO

PLACEBO COMPARATOR

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

Drug: PLACEBO

Interventions

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

Also known as: Gan-Lu-Yin

TCM Gan-Lu-Yin (GLY)

PLACEBO DRUG

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

PLACEBO

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chung Shan Medical University: lead

Study Sites (1)

Chung Shan Medical University Hospital

Taichung, 402, Taiwan

Location

MeSH Terms

Conditions

Sjogren's Syndrome

Interventions

gan-lu-siao-du-yin

Condition Hierarchy (Ancestors)

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

Study Officials

• Wei C- C, M

  Chung Shan Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: October 1, 2019
• Study Start: May 6, 2016
• Primary Completion: October 31, 2017
• Study Completion: December 31, 2017
• Last Updated: October 1, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)