Clinical Study for Migu Capsule in Improving Clinical symptoms and Pain-Related Cerebral Cortical Activity in Patients With Osteoporosis

Phase 1

Recruiting

• Conditions: osteoporosis/back pain

• Registration Number: ITMCTR1900002548
• Lead Sponsor: Shuguang 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: Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

? Meet the diagnostic criteria of osteoporosis;
? Meet the diagnostic criteria of liver and kidney insufficiency syndrome;
? Women have been menopausal for more than 1 year and aged from 45 to 75 years;
? Have low back pain more than 3 months and VAS scores>=3;
? Signing of informed consent.

Exclusion Criteria

? Patients with diseases that can cause secondary osteoporosis such as osteomalacia or multiple myeloma, and other diseases that affect bone metabolism.
? Spinal tuberculosis tumor osteomyelitis and other diseases which are difficult to evaluate the effectiveness of drugs.
? Abnormal serum calcium or parathyroid hormone (serum calcium level is higher than the upper limit of normal, and parathyroid hormone (PTH) is 1.5 times higher than the upper limit of normal).
? Patients with severe primary diseases such as epilepsy, severe cardiovascular and cerebrovascular diseases, abnormal liver and kidney functions, hematopoietic system, or serious diseases (such as tumor, etc.) that affect their survival or patients with psychosis.
? Allergic constitution or allergy to multiple drugs or foods or known allergy to research drugs and their ingredients.
? Patients enrolled in other clinical trials within the last month.
? Patients with contraindications to MRI.
? Patients who the researchers considered inappropriate to participate.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
functional magnetic resonance imaging;Pain VAS;

Secondary Outcome Measures

Name	Time	Method
Roland-Morris Scale;Hospital Anxiety and Depression Scale;SF-12;Bone mineral density;TCM score;bone metabolic markers;