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The efficacy and safety of Zhuangyao Tongluo Decoction in the treatment of lumbar disc herniation:a randomized,double- blind,double-simulated,parallel control clinical study

The efficacy and safety of Zhuangyao Tongluo Decoction in the treatment of lumbar disc herniation:a randomized,double- blind,double-simulated,parallel control clinical study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2022000034
Enrollment
Unknown
Registered
2022-06-26
Start date
2022-08-01
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

Lumbar disc herniation

Interventions

trial group:Zhuangyao Tongluo decoction granules + Celecoxib capsule simulator
Control group:Zhuangyao Tongluo Decoction simulator + Celecoxib capsule

Sponsors

China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1)Comply with the diagnostic criteria of lumbar disc herniation; 2) Aged between 18 and 75 years old; 3)If you have received other conservative treatment, you need more than 7 days of wash-out period; 4) Volunteer to participate, sign the informed consent form, and be willing to accept the test; 5)leg VAS pain score = 4 and < 7. Those who meet the above five options are eligible for this clinical study.

Exclusion criteria

Exclusion criteria: 1 ) Patients with spinal infections, tumors, tuberculosis, traumatic fractures, ankylosing spondylitis, etc. 2 ) Patients with severe pain, cauda equina nerve symptoms or lower limb muscle strength decrease who met the surgical indications. 3 ) Patients with previous lumbar surgery ; 4 ) Pregnancy and lactation women. 5 ) Patients with mental diseases or other reasons that do not cooperate. 6 ) Patients with severe cardiovascular, renal, liver, gastrointestinal ulcers, hematopoietic system diseases. 7 ) Patients with allergic constitution or known allergy to drugs and their components ( including sulfonamides ) used in this experiment.

Design outcomes

Primary

MeasureTime frame
VAS scores of leg pain;

Secondary

MeasureTime frame
SF-12;ODI scores;JOA scores;VAS scores of lumbar pain;

Countries

China

Contacts

Public ContactYang Kexin
13611261137@163.com13611261137

Outcome results

None listed

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