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Lumbar Disc HerniationPhase 3NCT03386149

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

A Phase 3 study testing Bosinji, Loxonine tab. and Acupuncture in people with Lumbar Disc Herniation, run by Kyunghee University Medical Center at 4 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Lumbar Disc Herniation
What is being tested?
Bosinji, Loxonine tab. and Acupuncture
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
4 sitesSouth Korea
Study dates
28 Dec 2017to 22 Jan 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 13Show fewer
  • 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

Trial locations and contacts

4 sites in 1 country.

South Korea4 sites

  • Daegu Korean Medicine Hospital of Daegu Haany University

    Daegu, 42158

  • Dongguk University Bundang Oriental Hospital

    Seongnam-si, Gyeonggi-do, 13601

  • Kyunghee University Medical Center

    Seoul, 02447

  • Kyung Hee University Hospital at Gangdong

    Seoul, 05278

Other trials in South Korea

About this study

Official 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

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.

Read the detailed description

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).

Being tested
Bosinji, Loxonine tab., Acupuncture
Keywords
Herniated Intervertebral Disc of Lumbar Spine, Low Back Pain, Radiculopathy, Bosinji, Herbal Medicine
Medical subject headings
Intervertebral Disc Displacement, Low Back Pain, Radiculopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BosinjiDrug

    Also called Ucha-Shinki-Hwan

    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

  • Loxonine tab.Drug

    Also called Loxoprofen

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

  • AcupunctureProcedure or surgery

    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)
Study groups in NCT03386149
Study groupRoleWhat they receive
Experimental GroupExperimentalIn the experimental group, 2.5g of Bosinji granule (Tsmura Co., Tokyo, Japan) will be orally administered three times a day at 30 minutes after the meal for 6 weeks. During the same period, acupuncture treatment on 20 predefined acupoints will be conducted once a week.
Receives: Drug: Bosinji; Procedure: Acupuncture
Control GroupActive comparatorIn the control group, Loxonine tab. (loxoprofen 60mg, Dong Wha Pharm Co., Ltd, Seoul, Korea) will be orally administered three times a day at 30 minutes after the meal for 6 weeks. During the same period, acupuncture treatment on 20 predefined acupoints will be conducted once a week.
Receives: Drug: Loxonine tab.; Procedure: Acupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measurement instrument for subjective pain

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

Secondary outcomes (6)

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

    Measurement instrument for subjective pain

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

  2. Oswestry Disability Index (ODI)

    Validated questionnaire for disability of low back pain

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

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

    Standardized instrument for generic health status

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

  4. Roland-Morris Disability Questionnaire (RMDQ)

    Health status measure for low back pain

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

  5. Global Perceived Effect (GPE)

    Assessment of change in the patient's chief complaint

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

  6. Deficiency Syndrome of Kidney Index (DSKI)

    Questionnaire for assessing symptoms related to deficiency syndrome of kidney

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2017
  2. Study start28 Dec 2017
  3. Primary completion27 Dec 2019
  4. Study completion22 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03386149
Sponsor's protocol ID
KHNMCOH 2017-08-002
Status last verified
Feb 2020
First submitted
21 Dec 2017
Last updated
5 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Goo B, Kim JH, Kim EJ, Nam D, Lee HJ, Kim JS, Park YC, Baek YH, Nam SS, Seo BK. Clinical research on the effectiveness and safety of Uchasingihwan for low back pain with radiculopathy caused by herniated intervertebral disc of the lumbar spine: A multicenter, randomized, controlled equivalence trial. Integr Med Res. 2024 Dec;13(4):101090. doi: 10.1016/j.imr.2024.101090. Epub 2024 Sep 30.

    PubMed 39640075

  • Goo B, Kim SJ, Kim EJ, Nam D, Lee HJ, Kim JS, Park YC, Baek YH, Nam SS, Seo BK. Clinical research on the efficacy and safety of Bosinji for low back pain with radiculopathy caused by herniated intervertebral disc of the lumbar spine: A protocol for a multicenter, randomized, controlled equivalence trial. Medicine (Baltimore). 2018 Dec;97(50):e13684. doi: 10.1097/MD.0000000000013684.

    PubMed 30558079

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bosinji, Loxonine tab. and Acupuncture in people with Lumbar Disc Herniation, run by Kyunghee University Medical Center at 4 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03386149, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.

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