Observation of the clinical efficacy of Guigui Zhuanggu Tablets in the treatment of postmenopausal osteoporotic low back pain based on the theory of

Phase 2

• Conditions: Postmenopausal osteoporosis

• Registration Number: ITMCTR2000004127
• Lead Sponsor: Xiangshan Hospital of Traditional Chinese Medicine, Huangpu District, Shanghai

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: Female
• Target Recruitment: Not specified

Inclusion Criteria

(1) Meet the diagnostic criteria for primary osteoporosis;
(2) Comply with the syndrome of deficiency of kidney yang and deficiency of liver and kidney in the diagnostic criteria of traditional Chinese medicine;
(3) Female, 45-75 years old, and natural menopause for more than 1 year;
(4) Low back pain, VAS <=5 points;
(5) Sign an informed consent form, willing to accept examinations, treatment, and be able to cooperate with follow-up.

Exclusion Criteria

(1) It is known to be allergic to the medicine ingredients in Caerqi D or Guigui Zhuanggu Tablets;
(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) Patients with low back pain caused by other reasons, such as patients with non-osteoporotic low back pain caused by lumbar fractures, spondylolisthesis, ankylosing spondylitis, lumbar spinal stenosis, lumbar disc herniation, lumbar muscle strain and other diseases;
(4) Other serious diseases affect bone metabolism;
(5) Patients with combined fractures requiring surgical treatment;
(6) Those who have been taking other drugs that affect bone metabolism at the same time for a long time and cannot be stopped immediately;
(7) Women in breast pregnancy;
(8) Those who have participated or are participating in other clinical research in the past 3 months.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Pain visual analog scale;Clinical Common Symptom Score;Bone metabolism indicators (Ca, P, PINP, ß-CTx, 25-OH-VitD, ALP, BGP);Bone density;

Secondary Outcome Measures

Name	Time	Method
Safety indicators (blood routine, liver and kidney function);SF-36 Quality of Life Score;Oswestry dysfunction index;