Trials Sponsors Conditions Drugs Pricing

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 tabletsOther

Acupuncture combined with oral hydroxychloroquine sulfate tablets

acupuncture combined with hydroxychloroquine sulfate tablets

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Treatment programme
Acupuncture combined with oral hydroxychloroquine sulfate tablets
The registry describes a treatment programme. Individual components, doses and actual administration are not established by this entry.
View registry record

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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:

Sponsors & Collaborators

Senyue Zhang
Otherlead

Study Sites (1)

Senyue Zhang

Harbin, Heilongjiang, 150040, China

MeSH Terms

Interventions

Hydroxychloroquine

Intervention Hierarchy (Ancestors)

ChloroquineAminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

Senyue Zhang
Heilongjiang University of Chinese Medicine
PRINCIPAL INVESTIGATOR

Enrollment

65 participants (actual enrollment reported by the registry).

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

Actual (reported)

Acupuncture Combined With Hydroxychloroquine

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (2)

acupuncture combined with hydroxychloroquine sulfate tablets

oral hydroxychloroquine sulfate tablets

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (2)

acupuncture combined with hydroxychloroquine sulfate tablets

oral hydroxychloroquine sulfate tablets

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations