Observation for the clinical effect of compound Qihuo tablet in the treatment of elderly osteoporotic low back pai

Not Applicable

• Conditions: Senile osteoporotic low back pain

• Registration Number: ITMCTR2000003570
• Lead Sponsor: onghua Hospital Affiliated to Shanghai University 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: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Meet the diagnostic criteria of western medicine for primary osteoporosis (T value <=-2.5SD is osteoporosis), meanwhile, TCM syndromes are patients with kidney deficiency and blood stasis syndrome;
2. Males and female patients aged 60 to 80 years old;
3. Those who have signed an informed consent form, are willing to accept examinations, treatments and can cooperate with follow-up;
4. Those who have not received any other treatment plan.

Exclusion Criteria

1. People with allergies;
2. Patients with secondary osteoporosis such as hyperparathyroidism, osteomalacia, rheumatoid arthritis, gout, multiple myeloma and other secondary osteoporosis; Patients with various endocrine diseases (such as Cushings disease, hyperthyroidism, hyperparathyroidism, hypothyroidism, diabetes, etc.);
3. With severe heart disease, severe liver and kidney insufficiency, malignant hypertension, severe heart failure, Severe arrhythmia;
4. Other serious diseases that affect bone metabolism; people who have been taking other drugs that affect bone metabolism at the same time for a long time and cannot be stopped immediately;
5. patients with mental illness;
6. those who have or are currently suffering from fractures other than the lumbar spine; Or those with hip implants;
7. Late deformity, disability, loss of labor;
8. People with a history of opioid analgesics, sedative hypnotics and alcohol abuse;
9. People with poor compliance and unable to meet follow-up requirements;
10. Pregnant and lactating women;
11. Patients with high blood calcium, or patients with kidney stone.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
The Short-form MPQ , SF-MPQ;

Secondary Outcome Measures

Name	Time	Method
ECOS-16;ODI;Bone density test;painDetect questionnaire, PD-Q;Scores of common clinical symptoms of traditional Chinese medicine;