Testifying Research Traditional Chinese Medicine Therapy supplementing Qi to Promote Body Fluid Production in Improving the Clinical Curative Effect

Phase 1

Completed

• Conditions: Primary Sj?gren's syndrome

• Registration Number: ITMCTR2000004149
• Lead Sponsor: Xiyuan Hospital of China Academy of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients with SS-related symptoms/signs can be diagnosed as SS if the following 3 objective tests meet 2 or more items
1. Serum anti-SSA and (or) anti-SSB antibody (+), or rheumatoid factor positive with ANA >=1:320;
2. The pathology of the labial glands showed lymphocyte foci >=1/4mm2 (at least 50 lymphocytes gathered in the 4mm2 tissue;
3. OSS (ocular staining score) for keratoconjunctivitis sicca: Staining score >=3 (the patient is not currently using eye drops due to glaucoma, and there is no history of corneal surgery and eye and face plastic surgery in the past 5 years);
Must be excluded: history of cervical, head and face radiotherapy, hepatitis C virus infection, AIDS, sarcoidosis, amyloidosis, graft versus host disease, IgG4-related diseases.
TCM syndrome differentiation standard
According to the pathological characteristics of primary Sjogrens syndrome and the functional characteristics of Runzao Decoction to invigorate qi, nourish fluid, nourish yin and moisturize dryness, and give consideration to specimens, the syndrome of deficiency of qi and body fluid was selected as the observation syndrome type (refer to Guiding Principles for Clinical Research of New Chinese Medicines and hygiene The Ministry of Traditional Chinese Medicine Syndrome Classification Standards was formulated).
The main symptoms: dry mouth and throat, dry eyes, fatigue, fatigue, abnormal tongue (tongue is bright red with little fluid, cracked, little or no coating, or tongue is fat and large).
Secondary symptoms: frequency of drinking, dry skin, dry nasal cavity; blurred vision, appetite, abdominal distension after eating, weak bowel movements, abnormal stools, or dry or loose stools.
Pulse condition: Shen thin and weak.
Tongue appearance: Except for light red and chapped, or the tongue is fat, or dark purple or ecchymosis.
It can be diagnosed with 4 main symptoms; or 2 main symptoms plus 2 or more minor symptoms.
In line with the 2012 ACR Sjogrens syndrome (diagnostic) criteria and the 2002 primary Sjogrens syndrome diagnostic criteria, the subject has clinical manifestations of spleen-qi deficiency and dryness, which can be diagnosed as pSS Qi-deficiency syndrome.
Case inclusion criteria
1) Aged 18 to 75 years old;
2) Primary Sjogren's syndrome that meets the above diagnostic criteria of Western medicine;
3) Primary Sjogrens syndrome that meets the above-mentioned TCM syndrome differentiation criteria;
4) Be informed and sign an informed consent form.

Exclusion Criteria

Case exclusion criteria
1) Excluding secondary Sjogren's syndrome caused by mixed connective tissue disease, rheumatoid arthritis, and systemic lupus erythematosus;
2) Exclude those who belong to the category of Diabetes in Chinese medicine but do not meet the diagnostic criteria of Western medicine for Sjogrens syndrome;
3) Pregnant or lactating women.
4) People with allergies or allergic to the components of the medicine.
5) Patients with severe primary diseases such as heart, brain, liver, kidney, hematopoietic system, etc.
6) Mental patients.
7) It is suspected that there is a history of alcohol or drug abuse, or other medical history that reduces the possibility of enrollment or complicates enrollment according to the judgment of the investigator, such as frequent changes in the work environment, which may easily cause loss to follow-up.
8) Those who have participated in or are participating in other drug clinical trials within 1 month.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Schirmer Test;Dry mouth score;Improvement degree of spleen deficiency symptoms;Score of the number of nights drinking water every night;BUT tear film rupture time;Skin dryness score;Saliva flow rate;Dry Eye Score;Nasal dryness score;