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Clinical efficacy of Huangqi Shengmai Yin in the treatment of Sj?gren's syndrome of Qi and Yin deficiency type

Clinical efficacy of Huangqi Shengmai Yin in the treatment of Sj?gren's syndrome of Qi and Yin deficiency type

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069113
Enrollment
Unknown
Registered
2023-03-07
Start date
2023-03-04
Completion date
Unknown
Last updated
2023-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sj?gren's syndrome

Interventions

Treatment Group:Huangqi Shengmai Yin + hydroxychloroquine sulfate
Control Group:hydroxychloroquine sulfate

Sponsors

The Affiliated Hospital of Yunnan University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) conformed to the 2016 ACR/EULAR pSS classification criteria; (2) meeting the criteria for Sj?gren's syndrome differentiation of deficiency of Qi and Yin deficiency in Sj?gren's syndrome; (3) age ranged from 18 to 70 years with no gender restriction, (4) being conscious and able to answer questions freely and complete the case report form, (5) agreeing and signing the informed consent form.

Exclusion criteria

Exclusion criteria: (1) patients with other connective tissue disease, HCV infection, AIDS, lymphoma, sarcoidosis, etc;(2)extensive or severe skin lesions;(3) moderate and high active myositis;(4) severe and rapidly progressive interstitial pneumonia;(5) patients with severe diseases of cardiovascular system, liver, kidney, nervous system and hematopoietic system;(6) those who had used hydroxychloroquine before and had obvious adverse reactions;(7) patients with fundus diseases;(8) allergic constitution;(9) preparing pregnant women, pregnant women, lactating women and those with mental diseases;(10) are participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Routine blood testing;Liver function test;Kidney function test;ESSPRI;ESSDAI;TCM syndrome score;ESR;immunological function;ANAS;Dry mouth and dry eyes;

Secondary

MeasureTime frame
Pigmentation;

Countries

China

Contacts

Public ContactTang Xiaohu

Yunnan Traditional Chinese Medicine Hospital

h.tang0718@163.com13064214246

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026