Acupuncture Combined With Hydroxychloroquine

Senyue Zhang

Status: Completed

Conditions: Primary Sjögren's Syndrome

Treatments: Other: Acupuncture combined with oral hydroxychloroquine sulfate tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT06432101

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Details and patient eligibility

About

To observe the clinical efficacy of acupuncture combined with hydroxychloroquine sulfate tablets on the symptoms of dry mouth and dry eyes in primary Sjögren's syndrome.

Full description

Methods: Seventy-two patients with primary Sjögren's syndrome who met the inclusion criteria were randomly divided into the experimental group (36 patients, 3 patients who fell out) and the control group (36 patients, 4 patients who fell out). The control group was treated with oral hydroxychloroquine sulfate tablets alone, 0.2g each time, taken twice a day, 4 weeks for 1 course of treatment, a total of 2 courses of treatment, and the experimental group was treated with acupuncture treatment on the basis of the control group, acupuncture once a day, acupuncture for 5 days and 2 days of rest, 4 weeks for 1 course of treatment, a total of 2 courses of treatment. The changes in the outcome indicators of the two groups before and after treatment were observed, and the main outcome indicators included salivary flow rate (SFR) and Schirmer test. Secondary outcomes included the European League Against Rheumatism (EULAR) Sjögren's Syndrome Patient-Reported Index (ESSPRI), the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI), and laboratory measures (ESR, CRP, IgG).

Enrollment: 65 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of primary Sjögren's syndrome
• Must be able to receive acupuncture treatment and swallow tablets

Exclusion criteria

• Patients with malignant tumors or severe organ function impairment
• Patients who are lactating or pregnant.
• Persons who are participating in clinical trials of other drugs.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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65 participants in 2 patient groups

acupuncture combined with hydroxychloroquine sulfate tablets

Active Comparator group

Description:

Acupuncture combined with oral hydroxychloroquine sulfate tablets

Treatment:

Other: Acupuncture combined with oral hydroxychloroquine sulfate tablets

oral hydroxychloroquine sulfate tablets

No Intervention group

Description:

Oral hydroxychloroquine sulfate tablets (Shanghai Shangyao Sino-Western Pharmaceutical Co., LTD., Fenle, Sinopyma approval number H19990263, 0.1g x 14 tablets) were treated with 0.2g each time, twice a day, 4 weeks for 1 course of treatment, a total of 2 courses of treatment.