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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2000004127

Enrollment

Unknown

Registered

2020-12-03

Start date

2021-02-01

Completion date

Unknown

Last updated

2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postmenopausal osteoporosis

Interventions

Control group:Calci D, Guigui Zhuanggu Tablets placebo

Experimental group:Calci D, Guigui Zhuanggu Tablets

Eligibility

Sex/Gender

Female

Age

45 Years to 75 Years

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

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

Countries

China

Contacts

Public ContactWei-Yi Zhan

Xiangshan Hospital of Traditional Chinese Medicine, Huangpu District, Shanghai

weiyizhan@126.com+86 13816978370

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026