Acupuncture Combined With Hydroxychloroquine

NCT06432101 | Completed

• 1 other identifier: 595661170@qq.com
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Primary Sjögren's Syndrome

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Sjögren's syndrome patient-reported index (ESSPRI)

  8 weeks

• EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) score

  8 weeks

Study Arms (2)

acupuncture combined with hydroxychloroquine sulfate tablets

ACTIVE COMPARATOR

Acupuncture combined with oral hydroxychloroquine sulfate tablets

Other: Acupuncture combined with oral hydroxychloroquine sulfate tablets

oral hydroxychloroquine sulfate tablets

NO INTERVENTION

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.

Interventions

Acupuncture combined with oral hydroxychloroquine sulfate tablets OTHER

Acupuncture combined with oral hydroxychloroquine sulfate tablets

acupuncture combined with hydroxychloroquine sulfate tablets

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Senyue Zhang: lead

Study Sites (1)

Senyue Zhang

Harbin, Heilongjiang, 150040, China

Location

MeSH Terms

Interventions

Hydroxychloroquine

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Senyue Zhang

  Heilongjiang University of Chinese Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 29, 2024
• Study Start: January 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)