Acupuncture Combined With Hydroxychloroquine

Primary Sjögren's Syndrome Clinical Trial

Official title:

Clinical Efficacy of Acupuncture Combined With Hydroxychloroquine Sulfate Tablets in Improving Oral and Ocular Dryness in Primary Sjögren's Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06432101
• Other study ID #: 595661170@qq.com
• Status: Completed
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2024
• Source: Heilongjiang University of Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Primary Sjögren's Syndrome
• Sjogren's Syndrome
• Syndrome

Intervention

Other:
• Acupuncture combined with oral hydroxychloroquine sulfate tablets
Acupuncture combined with oral hydroxychloroquine sulfate tablets

Locations

Country	Name	City	State
China	Senyue Zhang	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
Senyue Zhang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Salivary flow rate (Sauf)	Used to evaluate the salivary flow rate of pSS patients before and after treatment. Before the start of the experiment, the patient gargled with water to keep the mouth clean and free of irritation. Saliva collected at the bottom of the mouth and spit it into the measuring cup every 1min. After collecting it for 10min, the value was recorded. The less the saliva flow rate within 10 minutes, the worse the symptoms, and less than 1ml is abnormal.	8 weeks
Primary	Schirmer test	Used to evaluate the degree of tear secretion in pSS patients before and after treatment. The 5mm×35mm filter paper was folded at a right Angle at 5mm from one end, and the end was placed in the conjunctival sac at 1/3 of the outer eyelid of the patient. The eyes were closed and the clamp was held for 5min, and the wet length of the filter paper was measured, and the filter paper was positive if it was less than 5mm/5min. The less tears are secreted within five minutes, the more severe the symptoms.	8 weeks
Secondary	Sjögren's syndrome patient-reported index (ESSPRI)	Used to assess the degree of dryness, pain, and fatigue in pSS patients, it is an evaluation of disease activity based on patients' subjective feelings. On a scale of 0 to 10 from mild to severe, the final ESSPRI score is the average score of dryness, pain and fatigue. Scores <5 were classified as acceptable symptom status and >5 as unsatisfactory symptom status.	8 weeks
Secondary	EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) score	used to evaluate disease activity in patients with pSS, ESSDAI is an evaluation of disease activity based on objective facts. The score weight includes 12 dimensions, including systemic symptoms, lymph node disease, glandular disease, joint disease, skin disease, peripheral neuropathy, central neuropathy, lung disease, kidney disease, muscle disease, hematological diseases and serological changes. The total score of ESSDAI is equal to the sum of the score of the severity of each system × the product of the weight of the system. A scale of <5 was classified as low disease activity, 5 to 13 as moderate disease activity, and >14 as high disease activity.	8 weeks