Clinical effect of modified decoction of Fangji Huangqi Tang on treatment of polymyalgia rheumatica with dampness obstruction of spleen deficiency

Phase 1

• Conditions: polymyalgia rheumatica

• Registration Number: ITMCTR2100005081
• Lead Sponsor: Beijing Hospital of Traditional Chinese Medicine, Capital Medical University

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: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Western medicine diagnostic criteria:
(1) Aged > 50 years;
(2) Muscle pain and morning stiffness in one of the neck, shoulder girdle and pelvic girdle, and the duration of the disease is more than 1 week;
(3) ESR increases rapidly and CRP increases;
(4) Low-dose glucocorticoids (prednisone<=15mg/day) are effective;
(5) No muscle weakness or muscle atrophy, and muscle redness, heat and swelling;
(6) Exclude other lesions similar to PMR manifestations such as myositis, tumor, rheumatoid arthritis, chronic infection, etc.
2. Diagnostic criteria for spleen deficiency and damp resistance syndrome:
Shenpi fatigue, shortness of breath, lazy speech, low voice, numbness and heavy limbs, heavy muscles and ligaments, soreness and pain, soreness and weakness of limbs, inability to lift, pale complexion, poor appetite, fullness and fullness in the stomach and abdomen, loose stools, the tongue is pale, the body is fat with tooth marks, the coating is white and greasy, and the pulse is deep and slow.

Exclusion Criteria

1. Incomplete data and or non-prescribed medication, etc., which affect the judgment of efficacy or safety;
2. Patients with liver cirrhosis, chronic lung inflammation, patients with peptic ulcer in the past 3 months, recent fractures, etc. who cannot take hormones;
3. Patients taking steroids or immunosuppressants;
4. Obvious abnormal liver and kidney function;
5. Patients with mental illness or disturbance of consciousness who cannot cooperate with treatment.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Evaluation standard of curative effect of traditional Chinese Medicine;ESR;Polymyalgia rheumatica activity score;C-reactive protein;