Primary Sjögren SyndromePhase 2NCT06519617
Study on Optimization and Evaluation of Integrated Chinese and Western Medicine for pSS Glandular Damage
A Phase 2 study testing Yi Qi Yang Yin Decoction and Hydroxychloroquine Sulfate in people with Primary Sjögren Syndrome, run by Qingwen Tao at 1 site in China.
Trial summary
ChatGPT In a randomized controlled trial, 136 patients with primary Sjögren's syndrome (pSS) meeting the inclusion criteria were enrolled and randomly divided into two groups of 68 each. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Sjögren Syndrome
- What is being tested?
- Yi Qi Yang Yin Decoction and Hydroxychloroquine Sulfate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 1 siteChina
- Study dates
- 13 Jul 2024to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. clinical diagnosis of pSS and qi and yin deficiency ; 2.Sign the informed consent form.
Who cannot join
- 1. pSS activity system damage (ESSDAI score ≥5); 2. Combined connective tissue diseases other than pSS; 3. Pregnant or lactating women; 4. severe cardiovascular and cerebrovascular diseases, liver and kidney failure, and severe malignant tumors; 5. taking psychotropic drugs; 6. assessed by the investigator to be ineligible for enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
China-Japan friendship hospital
Beijing, Beijing Municipality, 100029
About this study
Official title: Study on Optimization and Evaluation of Integrated Chinese and Western Medicine for Primary Sjogren's Syndrome Glandular Damage
ChatGPT In a randomized controlled trial, 136 patients with primary Sjögren's syndrome (pSS) meeting the inclusion criteria were enrolled and randomly divided into two groups of 68 each. The treatment group received an optimized program combining Chinese and Western medicine for pSS glandular injury, while the control group received a conventional program for pSS glandular damage. The primary efficacy endpoint was the 12-week non-stimulated salivary flow rate (UWS) score. Secondary efficacy endpoints included the glandular damage Visual Analog Scale (VAS) scores, the European Sjögren's Syndrome Patient Reported Index (ESSPRI), among others. The treatment course lasted 12 weeks. The efficacy and safety of the optimized program for pSS glandular injury were evaluated by comparing within and between groups before and after treatment.
- Conditions
- Primary Sjögren Syndrome
- Being tested
- Yi Qi Yang Yin Decoction, Hydroxychloroquine Sulfate
- Keywords
- randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yi Qi Yang Yin DecoctionDrug
Also called The treatment group
The Yi Qi Yang Yin Decoction (Dihuang 15g, Baihe 12g, Nanshashen 15g, celery Qinghao 10g, Malt 10g, Shengma 6g, Chaihu 6g) prescription for patients eligible for qi and yin deficiency was 200 ml twice daily for 12 weeks.
Hydroxychloroquine SulfateDrug
Also called the control group
Hydroxychloroquine Sulfate Tablets 200-400mg daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| conventional program group | Sham comparator | Hydroxychloroquine Sulfate Tablets 200-400mg daily for 12 weeks. Receives: Drug: Hydroxychloroquine Sulfate |
| optimized program combining Chinese and Western medicine for pSS glandular damage | Active comparator | The herbal prescription for patients eligible for qi and yin deficiency was 200 ml twice daily for 12 weeks. Receives: Drug: Yi Qi Yang Yin Decoction |
What is being measured
The primary outcome is the main question the study is designed to answer.
UWS score
unstimulated flow rate of saliva score. it is positive if the UWS ≤1.5 ml/15 min（or 0.1 ml/min). Higher scores(ml/min) mean a better outcome.
Measured: 12 weeks after treatment
Secondary outcomes (3)
VAS score
the glandular damage Visual Analog Scale score(dryness, fatigue and pain in the limbs). Patient self-assessed VAS scores ranged from 0 to 10. Higher scores mean a worse outcome.
Measured: 12 weeks after treatment
ESSPRI
the European Sjögren's Syndrome Patient Reported Index, average of dryness, fatigue and pain in the limbs VAS scores. ESSPRI score varies from 0 to 10. Higher scores mean a worse outcome.
Measured: 12 weeks after treatment
Schirmer test
Lacrimal secretion test. it is positive if the UWS ≤5 mm/5 min（or 1 mm/min). Higher scores(mm/min) mean a better outcome.
Measured: 12 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start13 Jul 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sjögren 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The treatment group received an optimized program combining Chinese and Western medicine for pSS glandular injury, while the control group received a conventional program for pSS glandular injury.
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qingwen Tao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qingwen Tao, China-Japan Friendship Hospital
- Investigators
- Qingwem Tao, Study chair, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06519617
- Sponsor's protocol ID
- 2024-KY-173
- Status last verified
- Jul 2024
- First submitted
- 13 Jul 2024
- Last updated
- 25 Jul 2024
- Results posted
- 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 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Optimization and Evaluation of Integrated Chinese and Western Medicine for Primary Sjogren's Syndrome Glandular Damage
- ClinicalTrials.gov ID
- NCT06519617
- Acronym / sponsor ID
- 2024-KY-173
- Conditions
- Primary Sjögren Syndrome
- Keywords
- randomized controlled trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Qingwen TaoUniversity, hospital or other
- Study start
- 13 Jul 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Jul 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.
ChatGPT In a randomized controlled trial, 136 patients with primary Sjögren's syndrome (pSS) meeting the inclusion criteria were enrolled and randomly divided into two groups of 68 each. The treatment group received an optimized program combining Chinese and Western medicine for pSS glandular injury, while the control group received a conventional program for pSS glandular damage. The primary efficacy endpoint was the 12-week non-stimulated salivary flow rate (UWS) score. Secondary efficacy endpoints included the glandular damage Visual Analog Scale (VAS) scores, the European Sjögren's Syndrome Patient Reported Index (ESSPRI), among others. The treatment course lasted 12 weeks. The efficacy and safety of the optimized program for pSS glandular injury were evaluated by comparing within and between groups before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The treatment group received an optimized program combining Chinese and Western medicine for pSS glandular injury, while the control group received a conventional program for pSS glandular injury.
| Arm | Type | Receives |
|---|---|---|
| conventional program group | Sham comparator | Drug: Hydroxychloroquine SulfateHydroxychloroquine Sulfate Tablets 200-400mg daily for 12 weeks. |
| optimized program combining Chinese and Western medicine for pSS glandular damage | Active comparator | Drug: Yi Qi Yang Yin DecoctionThe herbal prescription for patients eligible for qi and yin deficiency was 200 ml twice daily for 12 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. clinical diagnosis of pSS and qi and yin deficiency ; 2.Sign the informed consent form.
Key exclusion criteria (1 listed)
- 1. pSS activity system damage (ESSDAI score ≥5); 2. Combined connective tissue diseases other than pSS; 3. Pregnant or lactating women; 4. severe cardiovascular and cerebrovascular diseases, liver and kidney failure, and severe malignant tumors; 5. taking psychotropic drugs; 6. assessed by the investigator to be ineligible for enrollment.
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 |
|---|---|---|
| Yi Qi Yang Yin DecoctionAlso: The treatment groupThe Yi Qi Yang Yin Decoction (Dihuang 15g, Baihe 12g, Nanshashen 15g, celery Qinghao 10g, Malt 10g, Shengma 6g, Chaihu 6g) prescription for patients eligible for qi and yin deficiency was 200 ml twice daily for 12 weeks. | Drug | optimized program combining Chinese and Western medicine for pSS glandular damage |
| Hydroxychloroquine SulfateAlso: the control groupHydroxychloroquine Sulfate Tablets 200-400mg daily for 12 weeks. | Drug | conventional program group |
Primary outcome
UWS score
Time frame: 12 weeks after treatment
unstimulated flow rate of saliva score. it is positive if the UWS ≤1.5 ml/15 min（or 0.1 ml/min). Higher scores(ml/min) mean a better outcome.
3 secondary outcomes
VAS score
Time frame: 12 weeks after treatment
ESSPRI
Time frame: 12 weeks after treatment
Schirmer test
Time frame: 12 weeks after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Primary Sjögren Syndrome
Active, not recruitingObservational study
Possible Sarcopenia, Sarcopenia, and Functional Status in Patients With Primary Sjögren's Syndrome
Primary Sjögren Syndrome, Sarcopenia
Active, not recruitingPhase 2
A Study of RSLV-132 in Females With Sjögren's Disease
Primary Sjögren Syndrome
Not yet recruitingPhase 2
Exosome and Mesenchymal Stem Cell Treatment for Salivary Gland Dysfunction in Primary Sjögren Syndrome
Sjogren Syndrome, Xerostomia
Recruiting
Exploring the Novel Value of PSMA PET in Sjögren's Syndrome: Integrated Analysis With Established FAPI PET Imaging
Primary Sjögren Syndrome, PET
Active, not recruiting
Immune Profile of Saliva and Serum of Patients With Primary Sjögren´s Syndrome
Sjogren's Syndrome
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.
Qingwem Tao study chair
China-Japan Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Yi Qi Yang Yin Decoction and Hydroxychloroquine Sulfate in people with Primary Sjögren Syndrome, run by Qingwen Tao 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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 25 Jul 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
UWS score (time frame: 12 weeks after treatment). 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 25 Jul 2024.