Acupuncture for Primary Sjögren Syndrome

G

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status and phase

Unknown
Phase 2

Conditions

Sjogren's Syndrome

Treatments

Device: Sham Acupuncture group
Device: acupuncture group

Study type

Interventional

Funder types

Other

Identifiers

NCT02691377
2015S320

Details and patient eligibility

About

The purpose of this study is to determine whether acupuncture is effective and safe in the treatment of Primary Sjögren Syndrome.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 2 patient groups

Acupuncture group
Experimental group
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.
Treatment:
Device: acupuncture group
Sham Acupuncture group
Sham Comparator group
Description:
Participants will receive sham acupuncture for 8 weeks. The procedure is the same as the acupuncture arm.
Treatment:
Device: Sham Acupuncture group

Trial contacts and locations

1

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Central trial contact

Ran Pang, MD; Xinyao Zhou, MD

Data sourced from clinicaltrials.gov

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