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A Study of Yiqi Yangyin Formula in the Treatment of Primary Sjogren's Syndrome

NCT07145060 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2025-08-28

No results posted yet for this study

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 for the research and development of new traditional Chinese medicine drugs for the effective treatment of pSS.

Conditions

  • Primary Sjögren's Syndrome (pSS)

Interventions

DRUG

Yiqi Yangyin Formula

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)

DRUG

Yiqi Yangyin Formula placebo

Yiqi Yangyin Formula placebo,has the same appearance, state, and taste as YQYYF, but contains 5% of the ingredients of Yiqi Yangyin Formula

Sponsors & Collaborators

  • China-Japan Friendship Hospital

    lead OTHER

Principal Investigators

  • Tao Qingwen Tao · China-Japan Friendship Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2028-01-31
Completion
2028-03-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07145060 on ClinicalTrials.gov