NCT02855658

Brief Summary

To evaluate the modulation of immunity-related gene expression for the Sjögren's syndrome under Chinese herbal medicine (SS-1) treatment.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2014

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 4, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

August 4, 2016

Status Verified

August 1, 2016

Enrollment Period

2.7 years

First QC Date

July 13, 2016

Last Update Submit

August 1, 2016

Conditions

Sjögren's Syndrome

Keywords

Sjögren's syndromeGan-Lu-YinSang-Ju-YinXuefu-Zhuyu-DecoctionOxidative stressImmune regulationGene modulationSS-1

Outcome Measures

Primary Outcomes (5)

  • Ocular surface disease index (OSDI)

    OSDI is an questionnaire of dry eye.

    7 months

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

    ESSPRI is an questionnaire of dry, pain and fatigue.

    7 months

  • Sjogren's syndrome symptoms Questionnaire

    Sjogren's syndrome symptoms Questionnaire is an questionnaire of dry month.

    7 months

  • Schirmer's test

    Schirmer's test is an objective detection of dry eye, which this test use paper strips inserted into the eye for 5 minutes to measure the production of tears.

    7 months

  • Salivary scintigraphy

    Salivary scintigraphy is an objective detection of dry month, which is used to detect the salivary flow in parotid gland of Sjogren's syndrome.

    7 months

Secondary Outcomes (4)

  • Oxidative stress and antioxidant capacity

    7 months

  • Quality of life (SF-36)

    7 months

  • Regulatory effect on cytokine

    7 months

  • Nanostring nCounter immune Panel

    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-1DRUG

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 12 weeks 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 12 weeks 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
PlaceboDRUG

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

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Taoyuan Chang Gung Memorial Hospital

Gueishan Township, Taiwan, 333, Taiwan

RECRUITING

China Medical University Hospital

Taichung, 404, Taiwan

RECRUITING

Related Publications (1)

  • Chang CM, Chu HT, Wei YH, Chen FP, Wang S, Wu PC, Yen HR, Chen TJ, Chang HH. The Core Pattern Analysis on Chinese Herbal Medicine for Sjogren's syndrome: A Nationwide Population-Based Study. Sci Rep. 2015 Apr 29;5:9541. doi: 10.1038/srep09541. Erratum In: Sci Rep. 2015 Oct 08;5:14887. doi: 10.1038/srep14887. Sci Rep. 2017 May 25;7:46824. doi: 10.1038/srep46824.

    PMID: 25923413RESULT

Related Links

MeSH Terms

Conditions

Sjogren's Syndrome

Interventions

sang ju yin

Condition Hierarchy (Ancestors)

Arthritis, RheumatoidArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesXerostomiaSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesDry Eye SyndromesLacrimal Apparatus DiseasesEye DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Hen-Hong Chang, M.D., Ph.D.

    China Medical University Hospital

    STUDY CHAIR

Central Study Contacts

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

CONTACT

+886-3196200tcmchh55@gmail.com

Ching-Mao Chang, M.D.

CONTACT

+886-919074951magicbjp@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

July 13, 2016

First Posted

August 4, 2016

Study Start

February 1, 2014

Primary Completion

October 1, 2016

Study Completion

April 1, 2017

Last Updated

August 4, 2016

Record last verified: 2016-08

Locations

TW(2)