Primary Sjögren's Syndrome (pSS)NCT07145060
A Study of Yiqi Yangyin Formula in the Treatment of Primary Sjogren's Syndrome
A study testing Yiqi Yangyin Formula in people with Primary Sjögren's Syndrome (pSS), run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
This project aims to conduct a prospective, randomized, double-blind, controlled clinical study to clarify the efficacy and safety of the YiQi YangYin Formula in treating patients with primary Sjogren's syndrome (pSS) presenting with Qi and Yin deficiency syndrome, with the expectation of providing a scientific basis… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Sjögren's Syndrome (pSS)
- What is being tested?
- Yiqi Yangyin Formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 31 Mar 2028
- Phase
- Interventional
- 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
- Patients aged18-75 years old (including the critical value), gender not limited;
- Patients meeting the classification criteria of primary Sjogren's syndrome in ACR/EULAR 2016;
- Patients with dry mouth VAS ≥4 and ESSDAI score < 5;
- Patients with positive autoantibodies (ANA or anti-SSA antibodies or anti-SSB antibodies or RF) and/or hyperimmunoglobulinemia or increased erythrocyte sedimentation rate;
- Patients meeting the syndrome of qi and Yin deficiency in traditional Chinese medicine;
- The subjects were informed and voluntarily signed the informed consent form.
Who cannot join
- Patients with a history of hypersensitivity or intolerance to any investigational therapeutic drug;
- Patients diagnosed with secondary Sjogren's syndrome or combined with other connective tissue diseases;
- Patients with severe lesions in the heart, brain, lungs, liver, kidneys, hematopoietic system, etc., as well as those with malignant tumors or infectious diseases;
- Patients who are pregnant, preparing for pregnancy or breastfeeding;
- Patients who have used cholinergic drugs or artificial tears/saliva in last 1 week;
- Patients who have used hydroxychloroquine, total glycosides of Paeonia lactide, Iguratimod, cyclophosphamide, cyclosporine A, tacrolimus, and azathioprine in last 1 month;
Show all 11Show fewer
- Patients who have used glucocorticoids, methotrexate or mycophenolate mofetil in last 3 months;
- Patients who have used Leflunomide in last 6 months;
- Patients who have used rituximab in last 6 months, or have used other biological agents (such as tofacitinib) other than rituximab in last 3 months;
- Patients who have participated in or are currently receiving any other experimental drugs or experimental medical devices within the past three months;
- Other situations that researchers consider ineligible for inclusion (such as cognitive impairment, taking psychotropic drugs).
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
Liu Zihan Liu, +86 15290302271, 3416309723@qq.com
About this study
Official title: A Randomized Controlled Study of Yiqi Yangyin Formula in the Treatment of Primary Sjogren's Syndrome
This project aims to conduct a prospective, randomized, double-blind, controlled clinical study to clarify the efficacy and safety of the YiQi YangYin Formula in treating patients with primary Sjogren's syndrome (pSS) presenting with Qi and Yin deficiency syndrome, with the expectation of providing a scientific basis for the research and development of new traditional Chinese medicine drugs for the effective treatment of pSS.
- Conditions
- Primary Sjögren's Syndrome (pSS)
- Being tested
- Yiqi Yangyin Formula, Yiqi Yangyin Formula placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yiqi Yangyin FormulaDrug
Also called The treatment group
Yiqi Yangyin Formula,consists of seven Chinese herbal medicines（Table 1）: Rehmanniae Radix (Sheng Di Huang), Lilium brownii (Bai He), Adenophorae Radix (Nan Sha Shen), Fructus Hordei Germinatus (Sheng Mai Ya), Artemisia annua (Qing Hao), Cimicifuga foetida (Sheng Ma) , and Bupleurum chinense(Chai Hu)
Yiqi Yangyin Formula placeboDrug
Also called The control group
Yiqi Yangyin Formula placebo,has the same appearance, state, and taste as YQYYF, but contains 5% of the ingredients of Yiqi Yangyin Formula
| Study group | Role | What they receive |
|---|---|---|
| Yiqi Yangyin Formula | Experimental | The herbal prescription for patients eligible for pSS "Qi-Yin deficiency syndrome" , 200 ml twice daily for 12 weeks. Receives: Drug: Yiqi Yangyin Formula |
| Yiqi Yangyin Formula placebo | Placebo comparator | The herbal prescription placebo for patients eligible for pSS "Qi-Yin deficiency syndrome" , 200 ml twice daily for 12 weeks. Receives: Drug: Yiqi Yangyin Formula placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unstimulated Whole Saliva flow rate (UWS)
Before the measurement, the participants should avoid eating, drinking, smoking, brushing teeth. and sit still for 10 minutes to collect all the saliva that flows out within 15 minutes in a clean container. The volume will be measured and the salivary secretion rate per unit time will be calculated, which is the UWS (ml/min). UWS ≤ 0.1 ml/min is defined as low UWS.
Measured: week0、week12
Secondary outcomes (9)
bilateral Schirmer's test
Without surface anesthesia, in a quiet and dim environment, bend the standard Schirmer filter paper at the scale and gently place it on the edge of the lower temporal eyelid of the subject. Instruct the subject to gently close their eyes and keep the filter paper for 5 minutes. After 5 minutes, remove the filter paper and measure the wet length. Schirmer≤5 mm/5 min indicates the presence of dry eye syndrome.
Measured: week0、week12
EULAR Sjögren Syndrome Patient Reported Index (ESSPRI)
The ESSRPI is a patient-reported index for Sjogren's syndrome, which includes scores for sjogren's symptoms, limb pain, and physical fatigue. The weights of the three aspects are the same, and each aspect's score ranges from 0 to 10. ESSPRI is defined as the average of these three aspects, with a score range of 0 to 10. The higher the value, the more severe the condition. A symptom state of less than 5 is acceptable to the patient, while a symptom state of ≥5 is unsatisfactory to the patient.
Measured: week0、week4、week8、week12
EULAR Sjögren syndrome disease activity index (ESSDAI)
Low activity is defined as ESSDAI < 5 points, moderate activity as 5≤ESSDAI≤13 points, and high activity as ESSDAI≥14 points
Measured: week0、week12
Sjögren's Tool for Assessing Response (STAR)
It includes the assessment of ESSDAI system involvement, the subjective perception assessment of ESSPRI patients, the functional changes of salivary glands and lacrimal glands, and the evaluation of serological indicators for treatment response. A total score of ≥5 is considered a treatment response.
Measured: week12
Composite of Relevant Endpoints for Sjogren Syndrome (CRESS)
It includes an assessment of five aspects，at least three out of the five have responded is defined as a response.
Measured: week 12
erythrocyte sedimentation rate (ESR), C-reactive protein (CRP)
conventional inflammatory marks
Measured: 0week、12week
36-Item Short Form Survey (SF-36)
The higher the score, the better the quality of life
Measured: week0、week12
serum immunoglobulin（IgA、IgM、IgG）
Compare the differences in the values of various serological indicators between the two groups of patients at the time of enrollment and 12 weeks after treatment, as well as the proportion of improvement and aggravation of serological indicators.
Measured: week0、week12
Complement (C3, C4）
Compare the differences in the values of various serological indicators between the two groups of patients at the time of enrollment and 12 weeks after treatment, as well as the proportion of improvement and aggravation of serological indicators.
Measured: week0、week12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Primary Sjögren's Syndrome (pSS)Studies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- 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
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luo Jing, China-Japan Friendship Hospital
- Investigators
- Tao Qingwen Tao, Study chair, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145060
- Sponsor's protocol ID
- 2024-QNQS-07
- Status last verified
- Aug 2025
- First submitted
- 4 Jul 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Seror R, Ravaud P, Mariette X, Bootsma H, Theander E, Hansen A, Ramos-Casals M, Dorner T, Bombardieri S, Hachulla E, Brun JG, Kruize AA, Praprotnik S, Tomsic M, Gottenberg JE, Devauchelle V, Devita S, Vollenweider C, Mandl T, Tzioufas A, Carsons S, Saraux A, Sutcliffe N, Vitali C, Bowman SJ; EULAR Sjogren's Task Force. EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI): development of a consensus patient index for primary Sjogren's syndrome. Ann Rheum Dis. 2011 Jun;70(6):968-72. doi: 10.1136/ard.2010.143743. Epub 2011 Feb 22.
PubMed 21345815Guo N, Wu F, Wu M, Wang Y, Lang Q, Lin X, Feng Y. Progress in the design and quality control of placeboes for clinical trials of traditional Chinese medicine. J Integr Med. 2022 May;20(3):204-212. doi: 10.1016/j.joim.2022.02.005. Epub 2022 Feb 21.
PubMed 35248517Day SJ, Altman DG. Statistics notes: blinding in clinical trials and other studies. BMJ. 2000 Aug 19-26;321(7259):504. doi: 10.1136/bmj.321.7259.504. No abstract available.
PubMed 10948038Brito-Zeron P, Theander E, Baldini C, Seror R, Retamozo S, Quartuccio L, Bootsma H, Bowman SJ, Dorner T, Gottenberg JE, Mariette X, Bombardieri S, de Vita S, Mandl T, Ng WF, Kruize AA, Tzioufas A, Vitali C, Buyon J, Izmirly P, Fox R, Ramos-Casals M; Eular Sjogren Syndrome Task Force. Early diagnosis of primary Sjogren's syndrome: EULAR-SS task force clinical recommendations. Expert Rev Clin Immunol. 2016;12(2):137-56. doi: 10.1586/1744666X.2016.1109449. Epub 2015 Dec 22.
PubMed 26691952Chan AW, Boutron I, Hopewell S, Moher D, Schulz KF, Collins GS, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne DR, Farmer AJ, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegfried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson DJ, Vohra S, White IR, Hrobjartsson A. SPIRIT 2025 statement: updated guideline for protocols of randomised trials. BMJ. 2025 Apr 28;389:e081477. doi: 10.1136/bmj-2024-081477.
PubMed 40294953Mentz RJ, Hernandez AF, Berdan LG, Rorick T, O'Brien EC, Ibarra JC, Curtis LH, Peterson ED. Good Clinical Practice Guidance and Pragmatic Clinical Trials: Balancing the Best of Both Worlds. Circulation. 2016 Mar 1;133(9):872-80. doi: 10.1161/CIRCULATIONAHA.115.019902.
PubMed 26927005Cheng CW, Wu TX, Shang HC, Li YP, Altman DG, Moher D, Bian ZX; CONSORT-CHM Formulas 2017 Group. CONSORT Extension for Chinese Herbal Medicine Formulas 2017: Recommendations, Explanation, and Elaboration. Ann Intern Med. 2017 Jun 27;167(2):112-121. doi: 10.7326/M16-2977. Print 2017 Jul 18.
PubMed 28654980Fox RI, Fox CM, Gottenberg JE, Dorner T. Treatment of Sjogren's syndrome: current therapy and future directions. Rheumatology (Oxford). 2021 May 14;60(5):2066-2074. doi: 10.1093/rheumatology/kez142.
PubMed 31034046Bowman SJ, Everett CC, O'Dwyer JL, Emery P, Pitzalis C, Ng WF, Pease CT, Price EJ, Sutcliffe N, Gendi NST, Hall FC, Ruddock SP, Fernandez C, Reynolds C, Hulme CT, Davies KA, Edwards CJ, Lanyon PC, Moots RJ, Roussou E, Giles IP, Sharples LD, Bombardieri M. Randomized Controlled Trial of Rituximab and Cost-Effectiveness Analysis in Treating Fatigue and Oral Dryness in Primary Sjogren's Syndrome. Arthritis Rheumatol. 2017 Jul;69(7):1440-1450. doi: 10.1002/art.40093. Epub 2017 Jun 5.
PubMed 28296257Ramos-Casals M, Brito-Zeron P, Bombardieri S, Bootsma H, De Vita S, Dorner T, Fisher BA, Gottenberg JE, Hernandez-Molina G, Kocher A, Kostov B, Kruize AA, Mandl T, Ng WF, Retamozo S, Seror R, Shoenfeld Y, Siso-Almirall A, Tzioufas AG, Vitali C, Bowman S, Mariette X; EULAR-Sjogren Syndrome Task Force Group. EULAR recommendations for the management of Sjogren's syndrome with topical and systemic therapies. Ann Rheum Dis. 2020 Jan;79(1):3-18. doi: 10.1136/annrheumdis-2019-216114. Epub 2019 Oct 31.
PubMed 31672775Brito-Zeron P, Retamozo S, Gheitasi H, Ramos-Casals M. Treating the Underlying Pathophysiology of Primary Sjogren Syndrome: Recent Advances and Future Prospects. Drugs. 2016 Nov;76(17):1601-1623. doi: 10.1007/s40265-016-0659-z.
PubMed 27844414Brito-Zeron P, Baldini C, Bootsma H, Bowman SJ, Jonsson R, Mariette X, Sivils K, Theander E, Tzioufas A, Ramos-Casals M. Sjogren syndrome. Nat Rev Dis Primers. 2016 Jul 7;2:16047. doi: 10.1038/nrdp.2016.47.
PubMed 27383445
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Yiqi Yangyin Formula in the Treatment of Primary Sjogren's Syndrome
- ClinicalTrials.gov ID
- NCT07145060
- Acronym / sponsor ID
- 2024-QNQS-07
- Conditions
- Primary Sjögren's Syndrome (pSS)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 28 Aug 2025 (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.
This project aims to conduct a prospective, randomized, double-blind, controlled clinical study to clarify the efficacy and safety of the YiQi YangYin Formula in treating patients with primary Sjogren's syndrome (pSS) presenting with Qi and Yin deficiency syndrome, with the expectation of providing a scientific basis for the research and development of new traditional Chinese medicine drugs for the effective treatment of pSS.
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 |
|---|---|---|
| Yiqi Yangyin Formula | Experimental | Drug: Yiqi Yangyin FormulaThe herbal prescription for patients eligible for pSS "Qi-Yin deficiency syndrome" , 200 ml twice daily for 12 weeks. |
| Yiqi Yangyin Formula placebo | Placebo comparator | Drug: Yiqi Yangyin Formula placeboThe herbal prescription placebo for patients eligible for pSS "Qi-Yin deficiency syndrome" , 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 (6 listed)
- Patients aged18-75 years old (including the critical value), gender not limited;
- Patients meeting the classification criteria of primary Sjogren's syndrome in ACR/EULAR 2016;
- Patients with dry mouth VAS ≥4 and ESSDAI score < 5;
- Patients with positive autoantibodies (ANA or anti-SSA antibodies or anti-SSB antibodies or RF) and/or hyperimmunoglobulinemia or increased erythrocyte sedimentation rate;
- Patients meeting the syndrome of qi and Yin deficiency in traditional Chinese medicine;
Key exclusion criteria (11 listed)
- Patients with a history of hypersensitivity or intolerance to any investigational therapeutic drug;
- Patients diagnosed with secondary Sjogren's syndrome or combined with other connective tissue diseases;
- Patients with severe lesions in the heart, brain, lungs, liver, kidneys, hematopoietic system, etc., as well as those with malignant tumors or infectious diseases;
- Patients who are pregnant, preparing for pregnancy or breastfeeding;
- Patients who have used cholinergic drugs or artificial tears/saliva in last 1 week;
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 |
|---|---|---|
| Yiqi Yangyin FormulaAlso: The treatment groupYiqi Yangyin Formula,consists of seven Chinese herbal medicines（Table 1）: Rehmanniae Radix (Sheng Di Huang), Lilium brownii (Bai He), Adenophorae Radix (Nan Sha Shen), Fructus Hordei Germinatus (Sheng Mai Ya), Artemisia annua (Qing Hao), Cimicifuga foetida (Sheng Ma) , and Bupleurum chinense(Chai Hu) | Drug | Yiqi Yangyin Formula |
| Yiqi Yangyin Formula placeboAlso: The control groupYiqi Yangyin Formula placebo,has the same appearance, state, and taste as YQYYF, but contains 5% of the ingredients of Yiqi Yangyin Formula | Drug | Yiqi Yangyin Formula placebo |
Primary outcome
Unstimulated Whole Saliva flow rate (UWS)
Time frame: week0、week12
Before the measurement, the participants should avoid eating, drinking, smoking, brushing teeth. and sit still for 10 minutes to collect all the saliva that flows out within 15 minutes in a clean container. The volume will be measured and the salivary secretion rate per unit time will be calculated, which is the UWS (ml/min). UWS ≤ 0.1 ml/min is defined as low UWS.
9 secondary outcomes
bilateral Schirmer's test
Time frame: week0、week12
EULAR Sjögren Syndrome Patient Reported Index (ESSPRI)
Time frame: week0、week4、week8、week12
EULAR Sjögren syndrome disease activity index (ESSDAI)
Time frame: week0、week12
Sjögren's Tool for Assessing Response (STAR)
Time frame: week12
Composite of Relevant Endpoints for Sjogren Syndrome (CRESS)
Time frame: week 12
erythrocyte sedimentation rate (ESR), C-reactive protein (CRP)
Time frame: 0week、12week
36-Item Short Form Survey (SF-36)
Time frame: week0、week12
serum immunoglobulin（IgA、IgM、IgG）
Time frame: week0、week12
Complement (C3, C4）
Time frame: week0、week12
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 28 Aug 2025.
- Results publication: PubMed 21345815Seror R, Ravaud P, Mariette X, Bootsma H, Theander E, Hansen A, Ramos-Casals M, Dorner T, Bombardieri S, Hachulla E, Brun JG, Kruize AA, Praprotnik S, Tomsic M, Gottenberg JE, Devauchelle V, Devita S, Vollenweider C, Mandl T, Tzioufas A, Carsons S, Saraux A, Sutcliffe N, Vitali C, Bowman SJ; EULAR Sjogren's Task Force. EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI): development of a consensus patient index for primary Sjogren's syndrome. Ann Rheum Dis. 2011 Jun;70(6):968-72. doi: 10.1136/ard.2010.143743. Epub 2011 Feb 22.
- Results publication: PubMed 35248517Guo N, Wu F, Wu M, Wang Y, Lang Q, Lin X, Feng Y. Progress in the design and quality control of placeboes for clinical trials of traditional Chinese medicine. J Integr Med. 2022 May;20(3):204-212. doi: 10.1016/j.joim.2022.02.005. Epub 2022 Feb 21.
- Results publication: PubMed 10948038Day SJ, Altman DG. Statistics notes: blinding in clinical trials and other studies. BMJ. 2000 Aug 19-26;321(7259):504. doi: 10.1136/bmj.321.7259.504. No abstract available.
- Results publication: PubMed 26691952Brito-Zeron P, Theander E, Baldini C, Seror R, Retamozo S, Quartuccio L, Bootsma H, Bowman SJ, Dorner T, Gottenberg JE, Mariette X, Bombardieri S, de Vita S, Mandl T, Ng WF, Kruize AA, Tzioufas A, Vitali C, Buyon J, Izmirly P, Fox R, Ramos-Casals M; Eular Sjogren Syndrome Task Force. Early diagnosis of primary Sjogren's syndrome: EULAR-SS task force clinical recommendations. Expert Rev Clin Immunol. 2016;12(2):137-56. doi: 10.1586/1744666X.2016.1109449. Epub 2015 Dec 22.
- Results publication: PubMed 40294953Chan AW, Boutron I, Hopewell S, Moher D, Schulz KF, Collins GS, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne DR, Farmer AJ, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegfried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson DJ, Vohra S, White IR, Hrobjartsson A. SPIRIT 2025 statement: updated guideline for protocols of randomised trials. BMJ. 2025 Apr 28;389:e081477. doi: 10.1136/bmj-2024-081477.
- Results publication: PubMed 26927005Mentz RJ, Hernandez AF, Berdan LG, Rorick T, O'Brien EC, Ibarra JC, Curtis LH, Peterson ED. Good Clinical Practice Guidance and Pragmatic Clinical Trials: Balancing the Best of Both Worlds. Circulation. 2016 Mar 1;133(9):872-80. doi: 10.1161/CIRCULATIONAHA.115.019902.
- Results publication: PubMed 28654980Cheng CW, Wu TX, Shang HC, Li YP, Altman DG, Moher D, Bian ZX; CONSORT-CHM Formulas 2017 Group. CONSORT Extension for Chinese Herbal Medicine Formulas 2017: Recommendations, Explanation, and Elaboration. Ann Intern Med. 2017 Jun 27;167(2):112-121. doi: 10.7326/M16-2977. Print 2017 Jul 18.
- Results publication: PubMed 31034046Fox RI, Fox CM, Gottenberg JE, Dorner T. Treatment of Sjogren's syndrome: current therapy and future directions. Rheumatology (Oxford). 2021 May 14;60(5):2066-2074. doi: 10.1093/rheumatology/kez142.
- Results publication: PubMed 28296257Bowman SJ, Everett CC, O'Dwyer JL, Emery P, Pitzalis C, Ng WF, Pease CT, Price EJ, Sutcliffe N, Gendi NST, Hall FC, Ruddock SP, Fernandez C, Reynolds C, Hulme CT, Davies KA, Edwards CJ, Lanyon PC, Moots RJ, Roussou E, Giles IP, Sharples LD, Bombardieri M. Randomized Controlled Trial of Rituximab and Cost-Effectiveness Analysis in Treating Fatigue and Oral Dryness in Primary Sjogren's Syndrome. Arthritis Rheumatol. 2017 Jul;69(7):1440-1450. doi: 10.1002/art.40093. Epub 2017 Jun 5.
- Results publication: PubMed 31672775Ramos-Casals M, Brito-Zeron P, Bombardieri S, Bootsma H, De Vita S, Dorner T, Fisher BA, Gottenberg JE, Hernandez-Molina G, Kocher A, Kostov B, Kruize AA, Mandl T, Ng WF, Retamozo S, Seror R, Shoenfeld Y, Siso-Almirall A, Tzioufas AG, Vitali C, Bowman S, Mariette X; EULAR-Sjogren Syndrome Task Force Group. EULAR recommendations for the management of Sjogren's syndrome with topical and systemic therapies. Ann Rheum Dis. 2020 Jan;79(1):3-18. doi: 10.1136/annrheumdis-2019-216114. Epub 2019 Oct 31.
- Results publication: PubMed 27844414Brito-Zeron P, Retamozo S, Gheitasi H, Ramos-Casals M. Treating the Underlying Pathophysiology of Primary Sjogren Syndrome: Recent Advances and Future Prospects. Drugs. 2016 Nov;76(17):1601-1623. doi: 10.1007/s40265-016-0659-z.
- Results publication: PubMed 27383445Brito-Zeron P, Baldini C, Bootsma H, Bowman SJ, Jonsson R, Mariette X, Sivils K, Theander E, Tzioufas A, Ramos-Casals M. Sjogren syndrome. Nat Rev Dis Primers. 2016 Jul 7;2:16047. doi: 10.1038/nrdp.2016.47.
- 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.
Tao Qingwen 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 study testing Yiqi Yangyin Formula in people with Primary Sjögren's Syndrome (pSS), run by China-Japan Friendship Hospital 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 6 inclusion and 11 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: opening soon, as of the sponsor's last update on 28 Aug 2025. 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.
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?
Contact Luo Jing Luo (+8618400664714, luojinggg@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unstimulated Whole Saliva flow rate (UWS) (time frame: week0、week12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07145060, which also lists 12 linked publications.
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 28 Aug 2025.