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Prospective and Observational Cohort Study of Zhuangyaojianshen Pill in Treating Lumbar Intervertebral Disc Herniation ( kidney deficiency and blood stasis Syndrome)

Prospective and Observational Cohort Study of Zhuangyaojianshen Pill in Treating Lumbar Intervertebral Disc Herniation ( kidney deficiency and blood stasis Syndrome)

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300075743
Enrollment
Unknown
Registered
2023-09-14
Start date
2023-03-15
Completion date
Unknown
Last updated
2023-09-18

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

Conditions

Lumbar Intervertebral Disc Herniation

Interventions

Exposure group (Taking Zhuangyaojianshen Pill):N/A
Non exposure group (Not taking Zhuangyaojianshen Pill):N/A

Sponsors

Tsinghua University Yuquan Hospital (Tsinghua University Hospital of Integrated Traditional Chinese and Western Medicine)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1)Meet the diagnostic criteria of lumbar disc herniation. (2)Conform to TCM syndrome differentiation standard of kidney deficiency and blood stasis syndrome. (3)Age 18-85 (including boundary), male or female. (4)30% = ODI = 80%. (5)Sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1)Presence of spinal infection, tumor, tuberculosis, lumbar spinal stenosis, traumatic fracture,ankylosing spondylitis, and severe osteoporosis etc. (2)Those who are accompanied by severe pain, cauda equina symptoms or lower limb muscle strength decline and other surgical indications; (3)Previous lumbar surgery (4)Asymptomatic lumbar disc herniation, non discogenic low back and leg pain (5)Pregnant and lactating women. (6)Patients with severe cardiovascular, renal, liver, digestive tract ulcer, hematopoietic system and other diseases, psychiatric patients. (7)Cold and fever. (8)Allergic constitution or known hypersensitivity to the drugs and their components used in this test. (9)Patients who have participated in other clinical trials within three months. (10)The researcher thinks it is not suitable to be included in this study.

Design outcomes

Primary

MeasureTime frame
Low back pain/lower limb pain NRS score;Evaluation of lumbar JOA score;The disability index questionnaire (ODI) score;TCM syndrome score and single score;

Countries

China

Contacts

Public ContactJia Yusong

Tsinghua University Yuquan Hospital (Tsinghua University Hospital of Integrated Traditional Chinese and Western Medicine)

13466584110@163.com+86 134 6658 4110

Outcome results

None listed

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