Evaluation of the Efficacy and the Mechanism of Chinese Herbal Formula SS-1 for Sjögren's Syndrome

NCT02110446 | Unknown Phase 2 DMC

• 1 other identifier: 102-2481A
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy of Chinese herbal medicine (SS-1) for the Sjögren's syndrome (SJS) patients.

Conditions

Sjögren's Syndrome

Keywords

Sjögren's syndrome; SS-1; Gan-Lu-Yin; Sang-Ju-Yin; Xuefu-Zhuyu-Decoction

Outcome Measures

Primary Outcomes (5)

• Ocular surface disease index (OSDI)

  SS-1 may improve the subjective observation of dry eye.

  7 months

• EULAR Sjogren's syndrome patient reported index (ESSPRI)

  SS-1 may improve the subjective sensation of dry, pain and fatigue.

  7 months

• SJS symptoms Questionnaire

  SS-1 may improve the subjective sensation of dry month.

  7 months

• Schirmer's test

  SS-1 may improve the objective observation of dry eye.

  7 months

• Salivary scintigraphy

  SS-1 may improve the objective observation of dry month.

  7 months

Secondary Outcomes (3)

• Oxidative stress and antioxidant capacity

  7 months

• Quality of life (SF-36)

  7 months

• Regulatory effect on cytokine

  7 months

Other Outcomes (3)

• Adverse effect (AE) and Adverse drug reaction(ADR)

  7 months

• Liver, Kidney and Blood function monitor

  7 months

• Traditional Chinese medicine (TCM) tongue diagnosis

  7 months

Study Arms (2)

SS-1

EXPERIMENTAL

SS-1 is composed of the powder of Gan-Lu-Yin, Sang-Ju-Yin and Xuefu-Zhuyu-Decoction with the ratio of 2:1:1. Patients take 6 gram of experiment medicine three times per day.

Drug: SS-1

Placebo

PLACEBO COMPARATOR

The placebo is composed of corn starch, pigment and minimal dose of 1% SS-1. Patients take 6 gram of experiment medicine three times per day.

Drug: Placebo

Interventions

SS-1 DRUG

The patients will be divided into two groups (A and B) at random and all of them keep the routine treatment in the rheumatology OPD. Group A patients will receive 12 weeks SS-1 treatment first, and then stop the SS-1 for 4 weeks for wash-out phase, and then receive 12weeks placebo treatment. Group B patients receive 12 weeks placebo first, and then stop the placebo treatment for 4 weeks for wash-out phase, and then receive 12weeks SS-1 treatment. SS-1 is composed of 3 traditional Chinese herbal formula: Gan-Lu-Yin, Sang-Ju-Yin and Xuefu-Zhuyu-Decoction with the ratio of 2:1:1. The placebo is composed with corn starch, pigment and minimal dose of 1% SS-1. Patients in both groups take 6 gram of SS-1/Placebo three times per day.

Also known as: Gan-Lu-Yin, Sang-Ju-Yin and Xuefu-Zhuyu-Decoction

SS-1

Placebo DRUG

The placebo is composed of corn starch, pigment and minimal dose of 1% SS-1. Patients take 6 gram of experiment medicine three times per day.

Also known as: 1% SS-1

Placebo

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• Chang Gung University: collaborator
• National Science and Technology Council, Taiwan: collaborator
• China Medical University, China: collaborator
• China Medical University Hospital: collaborator

Study Sites (1)

Center for Traditional Chinese Medicine, Taoyuan Chang Gung Memorial Hospital

Gueishan Township, Taoyuan, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Sjogren's Syndrome

Interventions

sang ju 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

• Hen-Hong Chang, M.D., Ph.D.

  Chang Gung University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hen-Hong Chang, M.D., Ph.D.

CONTACT

+886-3196200; tcmchh55@gmail.com

Ching-Mao Chang, M.D.

CONTACT

+886-3196200; magicbjp@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2014
• First Posted: April 10, 2014
• Study Start: February 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: February 2, 2016

Record last verified: 2016-01

Locations

TW (1)