Skip to content

Randomized controlled clinical study on the effectiveness and safety of Biqi Capsule combined with traditional Chinese and Western medicine in the treatment of lumbar discogenic pain with different syndrome types

Randomized controlled clinical study on the effectiveness and safety of Biqi Capsule combined with traditional Chinese and Western medicine in the treatment of lumbar discogenic pain with different syndrome types

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084447
Enrollment
Unknown
Registered
2024-05-16
Start date
2022-11-16
Completion date
Unknown
Last updated
2024-05-21

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

Conditions

discogenic low back pain

Interventions

Traditional Chinese patent medicines and simple preparations single drug group:biqi capsule
Western medicine monotherapy group:diclofenac
Integrated Traditional Chinese and Western Medicine Group:biqi capsule+diclofenac

Sponsors

Tianjin Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1.Western medicine diagnosis, traditional Chinese medicine diagnosis, and traditional Chinese medicine syndrome classification for discogenic lower back pain(Qi and blood deficiency syndrome, liver and kidney deficiency syndrome, or cold dampness obstruction syndrome) 2.Age between 18 and 60 years old, male and female unlimited 3.Visual Analog Scale (VAS) = 5 points for discogenic lower back pain 4.Voluntary signing of informed consent form

Exclusion criteria

Exclusion criteria: 1.Abnormal liver function test, with AST and/or ALT>1.5 times the upper limit of normal value 2.Abnormal renal function test, serum creatinine>upper limit of normal value 3.Patients with a history of gastrointestinal ulcers/bleeding or ulcer episodes in the past 4.Individuals with significant organ dysfunction or primary cardiovascular, cerebrovascular, and hematological diseases 5.Patients with combined mental disorders and other non cooperative treatments 6.Spinal fracture caused by trauma 7.Patients with tumors, inflammation, and tuberculosis of the lumbar spine bone and soft tissue 8.Patients with discogenic lower back pain complicated by severe cardiovascular disease and hysteria 9.Pregnant or lactating women, or those who refuse to use effective contraception within 30 days after signing an informed consent form and subsequent administration 10.Individuals with a history of drug abuse 11.Individuals with allergic constitution, known allergies to experimental drug components, and contraindications to experimental drugs 12.Patients participating in clinical trials of other drugs within the past month 13.The following possible interfering factors cannot be stopped, such as smoking, alcoholism, hip joint trauma, etc 14.Other reasons why researchers consider it inappropriate to participate in this study 15.Patients who require additional treatment(Including: opioid analgesics treatment, systemic glucocorticoid application, other Chinese medicine/traditional Chinese patent medicines and simple preparations treatment, acupuncture and moxibustion and massage, physical therapy, epidural injection or surgery)

Design outcomes

Primary

MeasureTime frame
VAS scores;

Secondary

MeasureTime frame
Traditional Chinese Medicine Syndrome Points;

Countries

China

Contacts

Public ContactWan Chunyou

Tianjin Hospital

wanchunyouxs@163.com+86 131 3200 3200

Outcome results

None listed

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