NCT07145060

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: China-Japan Friendship Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2025-09-01
• Primary completion: 2028-01-31
• Completion: 2028-03-31
• First posted: 2025-08-28
• Last updated: 2025-08-28

Locations

1 site across 1 country: China