Modulation of Immunity-related Gene Expression Under the Chinese Herbal Formula SS-1 Treatment for Sjögren's Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 15 August 2016
• Main ID: NCT02855658
• Date of registration: 13/07/2016
• Prospective Registration: No
• Primary sponsor: China Medical University Hospital
• Public title: Modulation of Immunity-related Gene Expression Under the Chinese Herbal Formula SS-1 Treatment for Sjögren's Syndrome
• Scientific title: Modulation of Immunity-related Gene Expression Under the Chinese Herbal Formula SS-1 Treatment for Sjögren's Syndrome
• Date of first enrolment: February 2014
• Target sample size: 90
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02855658
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Taiwan

Contacts

• Name: Hen-Hong Chang, M.D., Ph.D.

• Name: Hen-Hong Chang, M.D., Ph.D.
• Affiliation: China Medical University Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- Primary or Secondary Sjögren's syndrome patient

- Age from 20 to 75 year old, male or female patient

- Fit the criteria of 2002 year American-European classification

- If the subject took Cyclosporine, Cevimeline, Pilocarpine, Rituximab or other
biological agent before enter into our study, the subject need to stop these drugs
for one month

- If the subject took Gan-Lu-Yin, Sang- Ju-Yin or Xuefu-Zhuyu-Decoction before enter
into our study, the subject need to stop these drugs for one month

- Secondary Sjögren's syndrome patient:

- Stable treatment: Steroid (?10mg/d) and fixed hydroxychloroquine dose before 3
months enrolled

- No abnormal change of immunology, liver, kidney, and blood function

- No major life threatened condition

Exclusion Criteria:

- Alcohol abuse, DM (Glucose PC>200mg/dL) and major life threatened condition

- Pregnancy or breast feeding

- Abnormal liver and kidney function

- Forbid steroid pulse therapy before 3 months enrolled into our study, and forbid the
Chinese herbal medicine except SS-1



Age minimum: 20 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Sjögren's Syndrome

Intervention(s)

Drug: Placebo

Drug: SS-1

Primary Outcome(s)

Schirmer's test [Time Frame: 7 months]

Sjogren's syndrome symptoms Questionnaire [Time Frame: 7 months]

Ocular surface disease index (OSDI) [Time Frame: 7 months]

Salivary scintigraphy [Time Frame: 7 months]

EULAR Sjogren's syndrome patient reported index (ESSPRI) [Time Frame: 7 months]

Secondary Outcome(s)

Oxidative stress and antioxidant capacity [Time Frame: 7 months]

Nanostring nCounter immune Panel [Time Frame: 7 months]

Quality of life (SF-36) [Time Frame: 7 months]

Regulatory effect on cytokine [Time Frame: 7 months]

Secondary ID(s)

CMUH105-REC3-025

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Research Program for Biopharmaceuticals (NRPB)

Chang Gung Memorial Hospital

China Medical University, China