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Clinical Research on the Efficacy of Bosinji on Herniated Intervertebral Disc of Lumbar Spine

NCT03386149 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2020-02-05

No results posted yet for this study

Summary

This randomized controlled clinical trial is designed to evaluate the efficacy and safety of Bosinji on low back pain and radiating pain of lumbar herniated intervertebral disc (L-HIVD) by assessing pain, function, and quality of life.

Conditions

  • Lumbar Disc Herniation

Interventions

DRUG

Bosinji

Product name : Bosinji Granule Manufacturer : Tsumura \& Co. Ingredient : Bosinji granule 2.5g (Bosinji extract 1.523g) Bosinji extract is composed of following proportion of ingredient * Rehmannia Root 1.7g * Achyranthes Root 1.0g * Cornus Fruit 1.0g * Dioscorea Rhizome 1.0g * Psyllium Husk 1.0g * Alisma Rhizome 1.0g * Hoelen 1.0g * Moutan Root Bark 1.0g * Cinnamon Bark 0.3g * Pulvis Aconiti Tuberis Purificatum 0.3g

DRUG

Loxonine tab.

Product name : Loxonine tab. Manufacturer : Dong Wha Pharm. Co., Ltd Ingredient : Loxoprofen Sodium 68.1mg (Loxoprofen 60mg)

PROCEDURE

Acupuncture

Acupuncture treatment will be performed on 20 predefined acupoint using 0.25mm x 40mm acupuncture needle. The time for needle retaining is 15 minutes. 1. Both EX-B2 of herniated intervertebral disc level, its upper level and its lower level (6 acupoints) 2. Both side BL24, BL25, BL26, EX-B7, BL28 (10 acupoints) 3. Symptomatic side GB30, GB34, BL57, ST36 (4 acupoints)

Sponsors & Collaborators

  • Kyung Hee University Hospital at Gangdong

    collaborator OTHER

  • DongGuk University

    collaborator OTHER

  • Daegu Korean Medicine Hospital of Daegu Haany University

    collaborator OTHER

  • Kyunghee University Medical Center

    lead OTHER

Principal Investigators

  • Byung-Kwan Seo, PhD., KMD · Kyunghee University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-28
Primary Completion
2019-12-27
Completion
2020-01-22

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03386149 on ClinicalTrials.gov