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Completed

NCT Number: NCT03386149

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

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.

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Key information

Conditions

Lumbar Disc Herniation Back Pain Bone Diseases Hernia Intervertebral Disc Displacement Low Back Pain Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Radiculopathy Signs and Symptoms Spinal Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dongguk University Bundang Oriental Hospital, Seongnam-si, Gyeonggi-do, South Korea

Loading trial locations.

About this study

Seventy-four patients between the ages of 19 and 70 with L-HIVD will be recruited by eligibility criteria and randomly allocated to the experimental group and the control group. In the experimental group, 2.5g of Bosinji granule (Tsumura & Co., Tokyo, Japan) will be orally administered three times a day at 30 minutes after the meal for 6 weeks. In the control group, Loxonine tab. (loxoprofen 60mg, Dong Wha Pharm Co., Ltd, Seoul, Korea) will be orally administered in the same usage and period with the experimental group. In addition, both group will receive the same acupuncture treatment on 20 acupoints once a week for 6 weeks. 100 mm visual analogue scale (VAS) for low back pain will be assessed as a primary outcome at baseline and treatment end. Also, 100mm VAS for radiating pain, Oswestry disability index (ODI), Rolland Morris disability questionnaire (RMDQ), EQ-5D-5L and global perceived effect (GPE), Deficiency Syndrome of Kidney Index (DSKI) will be measured as secondary outcomes at baseline, 3 weeks after screening, treatment end (6 weeks, primary endpoint) and follow-up sessions (10 weeks).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men or women aged over 19 years
  • Radiating pain matched with severer abnormality than bulging shown by CT or MRI on lumbar spine
  • low back pain between 40 and 80 point on 100mm pain visual analogue scale
  • Volunteers who agree to participate and sign the Informed Consent Form, following a detailedexplanation of clinical trials

Exclusion criteria

  • Congenital abnormalities or surgical history on lumbar regions
  • Red flag signs that may be suspected of cauda equina syndrome, such as bladder and bowel dysfunction or saddle anesthesia
  • Tumor, fracture or infection in lumbar regions
  • Injection treatment on lumbar regions within 1 week
  • Psychiatric disorder currently undergoing treatment such as depression or schizophrenia
  • Liver function abnormality (AST or ALT over 2times normal range)
  • Renal fuction abnormaility (Serum creatinine > 2.0㎎/㎗)
  • Other diseases that could affect or interfere with therapeutic outcomes, including severe gastrointestinal disease, cardiovascular disease, hypertension, diabetes, renal disease, liver disease or thyroid disorder
  • Contraindication of NSAIDs including intercurrent disease, hypersensitivity reaction or other medication
  • Inappropriate condition for acupuncture due to skin disease or hemostatic disorder (PT INR > 2.0 or taking anticoagulant)
  • Women who is pregnant, breastfeeding or having pregnancy plan
  • Other inappropriate condition for herbal medicine treatment
  • participation in other clinical trial with 1 month

Treatment and study plan

Bosinji

Drug

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

Other names: Ucha-Shinki-Hwan

Loxonine tab.

Drug

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

Other names: Loxoprofen

Acupuncture

Procedure

Acupuncture treatment will be performed on 20 predefined acupoint using 0.25mm x 40mm acupuncture needle. The time for needle retaining is 15 minutes.

  • Both EX-B2 of herniated intervertebral disc level, its upper level and its lower level (6 acupoints)
  • Both side BL24, BL25, BL26, EX-B7, BL28 (10 acupoints)
  • Symptomatic side GB30, GB34, BL57, ST36 (4 acupoints)

Primary outcomes

  1. Change from Baseline 100mm Pain Visual Analogue Scale (VAS) for low back pain at Week 6

    Time frame: Week 0 (Baseline), Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U)

    Measurement instrument for subjective pain

Secondary outcomes

  1. 100mm Pain Visual Analogue Scale (VAS) for radiating pain

    Time frame: Week 0 (Baseline), Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U)

    Measurement instrument for subjective pain

  2. Oswestry Disability Index (ODI)

    Time frame: Week 0 (Baseline), Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U)

    Validated questionnaire for disability of low back pain

  3. EuroQol-5 dimensions-5 level (EQ-5D-5L)

    Time frame: Week 0 (Baseline), Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U)

    Standardized instrument for generic health status

  4. Roland-Morris Disability Questionnaire (RMDQ)

    Time frame: Week 0 (Baseline), Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U)

    Health status measure for low back pain

  5. Global Perceived Effect (GPE)

    Time frame: Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U)

    Assessment of change in the patient's chief complaint

  6. Deficiency Syndrome of Kidney Index (DSKI)

    Time frame: Week 0 (Baseline), Week 6 (Primary end point, Treatment end)

    Questionnaire for assessing symptoms related to deficiency syndrome of kidney

Sponsors and collaborators

Lead sponsor

Kyunghee University Medical Center

Other

Collaborators

  • Daegu Korean Medicine Hospital of Daegu Haany University
  • DongGuk University
  • Kyung Hee University Hospital at Gangdong

Registry information

Official study title

Clinical Research on the Efficacy and Safety of Bosinji on LBP and Radiculopathy by HIVD of L-spine; A Multicenter, Randomized, Controlled, Clinical Trial

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Dec 29, 2017
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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