Acupuncture Combined With Hydroxychloroquine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Primary Sjögren's Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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acupuncture combined with hydroxychloroquine sulfate tablets

Acupuncture combined with oral hydroxychloroquine sulfate tablets

Group Type ACTIVE_COMPARATOR

Acupuncture combined with oral hydroxychloroquine sulfate tablets

Intervention Type OTHER

Acupuncture combined with oral hydroxychloroquine sulfate tablets

oral hydroxychloroquine sulfate tablets

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Acupuncture combined with oral hydroxychloroquine sulfate tablets

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No