A multicenter, randomized, double-blind, double-simulation, positive drug parallel controlled clinical trial of Heng-Gu-Gu-Shang-Yu-He-Ji for the treatment of lumbar disc herniation

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300078935

Enrollment

Unknown

Registered

2023-12-21

Start date

2023-12-21

Completion date

Unknown

Last updated

2024-01-08

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

Conditions

Lumbar disc herniation

Interventions

Test group:Heng-Gu-Gu-Shang-Yu-He-Ji+Yaobitong Capsule Simulator

control group:Heng-Gu-Gu-Shang-Yu-He-Ji Simulator+Yaobitong Capsules

Eligibility

Sex/Gender

All

Age

35 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Conform to the western medical diagnostic criteria of lumbar disc herniation; 2.4 = VAS pain score =7; 3. In accordance with the TCM syndrome differentiation standard of liver and kidney deficiency combined with blood stasis syndrome; (4) 35-75 years old, have no plans to become pregnant during the screening period and within the next 3 months, voluntarily take effective contraceptive measures, and have no plans to donate sperm or eggs; 5. Voluntarily sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Low back pain or leg pain caused by lumbar tuberculosis, lumbar tumor, lumbar spinal stenosis, or complete prolapse of intervertebral disc; Patients with surgical indications; (2) patients with epidural injection within 1 month before screening; Patients who had used non-steroidal anti-inflammatory drugs, opioid analgesics, muscle relaxants, or other drugs for intervertebral disc herniation and related traditional Chinese medicine within 1 week before screening; (3) patients with life-threatening diseases of the heart, brain, liver, kidney and blood system, including ALT, AST > 1.5 times the upper limit of normal, Scr > the upper limit of normal; Patients with digestive tract ulcer and glaucoma; 4. Known to be allergic to celecoxib capsules or sulfonamides, allergic constitution or known to be allergic to the drugs and their components used in this trial; 5. Pregnant and lactating women; 6. Patients enrolled in other clinical trials within 3 months before screening; 7. Persons who were deemed by the investigators to be ineligible for the trial.

Design outcomes

Primary

Measure	Time frame
Visual analogue scale (VAS) score;	—

Secondary

Measure	Time frame
Oswestry disability index,ODI;TCM syndrome curative effect;	—

Countries

China

Contacts

Public ContactChen Weiheng

The Third Affiliated Hospital of Beijing University of Chinese Medicine

1732865549@qq.com+86 135 1101 3261

Outcome results

None listed

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