Evaluation of the Efficacy and the Mechanism of Chinese Herbal Formula SS-1 for Sjögren's Syndrome - A Randomized Control Trial
Evaluation of the Efficacy and the Mechanism of Chinese Herbal Formula SS-1 for Sjögren's Syndrome
Sponsors
Source
Chang Gung Memorial Hospital
Oversight Info
Has Dmc
Yes
Brief Summary
To evaluate the efficacy of Chinese herbal medicine (SS-1) for the Sjögren's syndrome (SJS)
patients.
Detailed Description
Investigators take a randomized, double-blinded, placebo-controlled, cross-over design
clinical trial to evaluate the effect of Chinese herbal medicine (SS-1) on the regulation of
oxidative-related cytokines and the antioxidant capacity for the Sjögren's syndrome (SJS)
patients. Through the oxidative stress reduction, the quality of life and clinical
manifestation will be improved. Investigators will also use a SJS cell model to elucidate the
antioxidant mechanism of SS-1.
The SJS patients in this clinical trial will be screened and be referred from the out-patient
department (OPD) of the Rheumatology Department of Chang Gung Memorial Hospital. 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 stop the SS-1 for 4 weeks to enter the wash-out phase, and then receive 12 weeks
placebo treatment after the wash-out phase. Group B patients receive 12 weeks placebo first
and stop the placebo treatment for 4 weeks to enter the wash-out phase, and then receive 12
weeks SS-1 treatment after the wash-out phase. 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 and the placebo is composed
with corn starch, pigment and 1/100 SS-1. Patients in both groups take 6 gram of experiment
medicine three times per day. Investigators plan to evaluate the associated parameters at the
time just before treatment (V1), after treatment for 12 weeks (V2), at the end of wash-out
phase (V3) and when the crossover treatment is completed (V4). Investigators use EULAR
Sjogren's syndrome patient reported index, ocular surface disease index and SJS symptom
questionnaire for clinical evaluation, and use the SF-36 for quality of life. And
investigators use the schirmer's test, salivary scintigraphy, oxidative stress marker and
related cytokine for objective observation.
Expected Results:
1. SS-1 may improve the clinical manifestation and quality of life for the patients with
Sjögren's syndrome
2. To evaluate the effect of the Chinese medicine on the tongue diagnosis before and after
treatment.
3. SS-1 may reduce the oxidative stress (8-OHdG and mtDNA 4977 bp deletion) and elevate the
antioxidant capacity (TAC, GSH, mtDNA copy number, SOD, GPX, CAT).
4. SS-1 may have the regulatory effect on cytokine secretion and immune function.
5. SS-1 may have the capacity of reducing the oxidative stress, elevating the antioxidant
capacity and regulating the immune response in the model of submaxillary salivary gland
cell line with the induction of IFN-γand IFN-α.
6. Identification of the single herb in the SS-1 mixture that regulates oxidative stress
and cytokine in the model of submaxillary salivary gland cell line, and set up of the
Chinese herbs screen platform for Sjögren's syndrome.
Overall Status
Unknown status
Start Date
2014-02-01
Completion Date
2016-07-01
Primary Completion Date
2016-07-01
Phase
Phase 2
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Ocular surface disease index (OSDI) |
7 months |
|
EULAR Sjogren's syndrome patient reported index (ESSPRI) |
7 months |
|
SJS symptoms Questionnaire |
7 months |
|
Schirmer's test |
7 months |
|
Salivary scintigraphy |
7 months |
Secondary Outcome
Measure |
Time Frame |
|
Oxidative stress and antioxidant capacity |
7 months |
|
Quality of life (SF-36) |
7 months |
|
Regulatory effect on cytokine |
7 months |
Enrollment
60
Condition
Intervention
Intervention Type
Drug
Intervention Name
Description
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.
Arm Group Label
SS-1
Other Name
Gan-Lu-Yin, Sang-Ju-Yin and Xuefu-Zhuyu-Decoction
Intervention Type
Drug
Intervention Name
Description
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.
Arm Group Label
Placebo
Other Name
1% SS-1
Eligibility
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
Gender
All
Minimum Age
20 Years
Maximum Age
75 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Hen-Hong Chang, M.D., Ph.D. |
Principal Investigator |
Chang Gung University |
Overall Contact
Location
Facility |
Status |
Contact |
Investigator |
|
Center for Traditional Chinese Medicine, Taoyuan Chang Gung Memorial Hospital Gueishan Township Taoyuan 333 Taiwan |
Recruiting |
Last Name: Ching-Mao Chang, M.D. Role: Sub-Investigator Last Name: Yau-Huei Wei, Ph.D. Role: Principal Investigator Last Name: Jr-Rung Lin, Ph.D. Role: Principal Investigator Last Name: Kuang-Hui Yu, M.D. Role: Principal Investigator Last Name: Shue-Fen Luo, M.D. Role: Principal Investigator Last Name: Hen-Hong Chang, M.D. Role: Principal Investigator Last Name: Yeong-Jian Jan Wu Jan, M.D. Role: Principal Investigator Last Name: Ji-Yih Chen, M.D. Role: Principal Investigator Last Name: Yao-Fan Fang, M.D. Role: Principal Investigator |
Location Countries
Country
Taiwan
Verification Date
2016-01-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keywords
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Arm Group
Arm Group Label
SS-1
Arm Group Type
Experimental
Description
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.
Arm Group Label
Placebo
Arm Group Type
Placebo Comparator
Description
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.
Firstreceived Results Date
N/A
Overall Contact Backup
Acronym
SS-1
Other Outcome
Measure
Adverse effect (AE) and Adverse drug reaction(ADR)
Time Frame
7 months
Description
Monitor the Adverse effect (AE) and Adverse drug reaction(ADR) during the SS-1 trial.
Measure
Liver, Kidney and Blood function monitor
Time Frame
7 months
Description
Monitor the Liver, Kidney and Blood function (RBC, WBC, Hb, PLT, AST, ALT, BUN, Cre) of patient during the SS-1 trial.
Measure
Traditional Chinese medicine (TCM) tongue diagnosis
Time Frame
7 months
Description
To evaluate the effect of the SS-1 on the TCM tongue diagnosis before and after treatment.
Patient Data
Sharing Ipd
Undecided
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Study First Submitted
April 1, 2014
Study First Submitted Qc
April 7, 2014
Study First Posted
April 10, 2014
Last Update Submitted
January 31, 2016
Last Update Submitted Qc
January 31, 2016
Last Update Posted
February 2, 2016
Last Known Status
Recruiting
ClinicalTrials.gov processed this data on December 12, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.