Primary Sjögren's SyndromeNCT06432101
Acupuncture Combined With Hydroxychloroquine
A study testing Acupuncture combined with oral hydroxychloroquine sulfate tablets in people with Primary Sjögren's Syndrome, run by Senyue Zhang at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Primary Sjögren's Syndrome
- What is being tested?
- Acupuncture combined with oral hydroxychloroquine sulfate tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of primary Sjögren's syndrome
- Must be able to receive acupuncture treatment and swallow tablets
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Efficacy of Acupuncture Combined With Hydroxychloroquine Sulfate Tablets in Improving Oral and Ocular Dryness in Primary Sjögren's Syndrome
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.
Read the detailed 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).
- Conditions
- Primary Sjögren's Syndrome
- Being tested
- Acupuncture combined with oral hydroxychloroquine sulfate tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture combined with oral hydroxychloroquine sulfate tabletsOther
Acupuncture combined with oral hydroxychloroquine sulfate tablets
| Study group | Role | What they receive |
|---|---|---|
| acupuncture combined with hydroxychloroquine sulfate tablets | Active comparator | Acupuncture combined with oral hydroxychloroquine sulfate tablets Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8 weeks
Secondary outcomes (2)
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start1 Jan 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sjögren's SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Senyue Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Senyue Zhang, Heilongjiang University of Chinese Medicine
- Investigators
- Senyue Zhang, Principal investigator, Heilongjiang University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06432101
- Sponsor's protocol ID
- 595661170@qq.com
- Status last verified
- May 2024
- First submitted
- 10 May 2024
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Acupuncture Combined With Hydroxychloroquine Sulfate Tablets in Improving Oral and Ocular Dryness in Primary Sjögren's Syndrome
- ClinicalTrials.gov ID
- NCT06432101
- Acronym / sponsor ID
- 595661170@qq.com
- Conditions
- Primary Sjögren's Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Senyue ZhangUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 29 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acupuncture combined with hydroxychloroquine sulfate tablets | Active comparator | Other: Acupuncture combined with oral hydroxychloroquine sulfate tabletsAcupuncture 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of primary Sjögren's syndrome
- Must be able to receive acupuncture treatment and swallow tablets
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture combined with oral hydroxychloroquine sulfate tabletsAcupuncture combined with oral hydroxychloroquine sulfate tablets | Other | acupuncture combined with hydroxychloroquine sulfate tablets |
Primary outcome
Salivary flow rate (Sauf)
Time frame: 8 weeks
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.
Schirmer test
Time frame: 8 weeks
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.
2 secondary outcomes
Sjögren's syndrome patient-reported index (ESSPRI)
Time frame: 8 weeks
EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) score
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Senyue Zhang principal investigator
Heilongjiang University of Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture combined with oral hydroxychloroquine sulfate tablets in people with Primary Sjögren's Syndrome, run by Senyue Zhang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary flow rate (Sauf) (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.