Efficacy and Safety of Acupuncture for Primary Sjögren Syndrome
Acupuncture for Primary Sjögren Syndrome
Sponsors
Source
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Oversight Info
Has Dmc
No
Brief Summary
The purpose of this study is to determine whether acupuncture is effective and safe in the
treatment of Primary Sjögren Syndrome.
Detailed Description
This randomized, double-blinded, sham acupuncture controlled trial is aimed to assess the
effectiveness and safety of acupuncture in the treatment of Primary Sjögren Syndrome.The
eligible participants will be randomly allocated to receive acupuncture or sham acupuncture
for 8 weeks.
Assuming a two-sided alpha of 0.05, power of 85%, and a 20% drop-out, a sample sized of 30
would be needed for each group. The statistical analysis will be based on the
intention-to-treat principle. Continuous variables will be compared by Student t test or
Mann-Whitney U test; categorical variables will be analyzed by chi-square test, Fisher's
exact test or Kruskal-Wallis H test as appropriate. For comparison between two time points,
paired t-test or Wilcoxon signed rank test will be used as appropriate. A statistically
significant difference was set at P<0.05.
Overall Status
Unknown status
Start Date
2016-03-01
Completion Date
2017-03-01
Primary Completion Date
2017-03-01
Phase
Phase 2
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
The proportion of participants who has a 30% or greater reduction in 2 of 3 items,including the numeric analog scale (NAS) of dryness, fatigue, and pain. |
24 weeks |
Secondary Outcome
Measure |
Time Frame |
|
Change in NAS of each item including dryness, fatigue, and pain. |
24 weeks |
|
Change in EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) |
24 weeks |
|
Change in Medical Outcome Study Short Form 36 Short-Form Health Survey (SF-36) |
24 weeks |
|
Change in Hospital Anxiety and Depression (HAD) scale score |
24 weeks |
|
Change in serum Immunoglobulin G (IgG),immunoglobulin A (IgA), and immunoglobulin M (IgM) levels |
24 weeks |
|
Change in image of Salivary glands measured by ultrasound |
24 weeks |
|
Change in Schirmer test score and unstimulated salivary flow |
24 weeks |
|
Adverse events |
24 weeks |
Enrollment
60
Condition
Intervention
Intervention Type
Device
Intervention Name
Description
Acupoints include 11 on the head, two on the upper extremities, and two on the lower extremities. Before performing acupuncture, a small pad will be pasted on each acupoint. All the needles will insert the acupoints through these pads. Then, they will be twirled, lifted and thrust three times to elicit the Deqi sensation. Each session will last 30 minutes.
Arm Group Label
Acupuncture group
Intervention Type
Device
Intervention Name
Description
The same acupoints with acupuncture group are selected.A placebo needle with a blunt tip will be used to perform sham acupuncture. They will only insert the pad and no skin penetration. The same procedure with acupuncture group will be performed.
Arm Group Label
Sham Acupuncture group
Eligibility
Criteria
Inclusion Criteria:
- To fulfill the American-European Consensus Group Criteria for primary Sjögren
syndrome.
- With the symptoms of primary Sjögren syndrome less than 5 years.
Exclusion Criteria:
- With an acupuncture contraindication (allergy to metals, skin lesions on relative
acupoints, etc.)
- Taking or taken medicine for primary Sjögren syndrome within last 4 weeks before the
enrollment.
Gender
All
Minimum Age
18 Years
Maximum Age
65 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Xinyao Zhou, MD |
Principal Investigator |
Guang'anmen Hospital |
Overall Contact
Location
Facility |
Status |
Contact |
|
Guang'anmen Hospital, China academy of Chinese Medical Sciences Beijing 100053 China |
Not yet recruiting |
Location Countries
Country
China
Verification Date
2016-02-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Investigator Full Name
Zhou Xinyao
Investigator Title
Attending Physician & Lecturer
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Arm Group
Arm Group Label
Acupuncture group
Arm Group Type
Experimental
Description
Participants will receive acupuncture for 8 weeks. In particular, acupuncture will be performed three times a week in earlier 4 weeks and twice a week in later 4 weeks.
Arm Group Label
Sham Acupuncture group
Arm Group Type
Sham Comparator
Description
Participants will receive sham acupuncture for 8 weeks. The procedure is the same as the acupuncture arm.
Firstreceived Results Date
N/A
Overall Contact Backup
Patient Data
Sharing Ipd
Undecided
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)
Study First Submitted
February 20, 2016
Study First Submitted Qc
February 20, 2016
Study First Posted
February 25, 2016
Last Update Submitted
February 26, 2016
Last Update Submitted Qc
February 26, 2016
Last Update Posted
February 29, 2016
Last Known Status
Not yet 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.