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.

开始日期2017-12-28

申办/合作机构

Kyunghee University Medical Center

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100 项与 Bosinji 相关的临床结果

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100 项与 Bosinji 相关的转化医学

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100 项与 Bosinji 相关的专利（医药）

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项与 Bosinji 相关的文献（医药）

2018-12-01·Medicine4区 · 医学

A protocol for a multicenter, randomized, controlled equivalence trial

4区 · 医学

ArticleOA

作者: Nam, Dongwoo ; Baek, Yong-Hyeon ; Lee, Hyun-Jong ; Kim, Eun-Jung ; Goo, Bonhyuk ; Kim, Jae-Soo ; Nam, Sang-Soo ; Seo, Byung-Kwan ; Kim, Sung-Jin ; Park, Yeon-Cheol

AbstractBackground:A lumbar herniated intervertebral disc (LHIVD) is a common problem that usually causes low back pain and radiating pain. The effectiveness of Bosinji, one of the herbal medicines used for low back pain and radiating pain in patient with LHIVD, has been reported in several studies; however, little clinical evidence is available owing to the methodological limitations in previous studies. Hence, the present study aims to establish the clinical evidence regarding the efficacy and safety of Bosinji in improving pain, function, and quality of life in LHIVD patients.Method/design:This is a multicenter, open-label, randomized, controlled, and equivalence trial with 2 parallel arms. A total of 74 patients who have low back pain and radiating pain due to LHIVD will be recruited and randomly allocated to the experimental group and control group. The patients in the experimental group and control group will take 2.5 g of Bosinji granule (1.523 g of Bosinji extract) or Loxonin tablet (60 mg of loxoprofen) 3 times a day for 6 weeks. Additionally, both groups will receive the same acupuncture treatment once a week for 6 weeks as a concurrent treatment. Changes in the 100-mm visual analogue scale (VAS) for low back pain after 6 weeks from baseline will be assessed as the primary outcome. Furthermore, the 100-mm VAS for radiating pain, Oswestry disability index (ODI), Roland–Morris disability questionnaire (RMDQ), EuroQol 5 Dimensions 5 Levels (EQ-5D-5L), global perceived effect (GPE), and deficiency syndrome of kidney index (DSKI) will be used to evaluate secondary outcomes. Outcomes will be assessed at baseline and at 3, 6, and 10 weeks after screening. For the safety evaluation, laboratory examinations including complete blood count, liver function test, renal function test, blood coagulation test, inflammation test, and urine analysis will be conducted before and after taking the medications.Discussion:The results of this trial will be used to establish clinical evidence regarding the use of Bosinji with acupuncture treatment in the treatment of patients with LHIVD.Trial registration number:NCT03386149 (clinicaltrials.gov) and KCT0002848 (Clinical Research Information Service of the Republic of Korea).

100 项与 Bosinji 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
椎间盘疾病	临床3期	韩国	Kyung Hee University Hospital at Gangdong	2017-12-28
椎间盘疾病	临床3期	韩国	Kyunghee University Medical Center	2017-12-28
腰痛	临床3期	韩国	Kyung Hee University Hospital at Gangdong	2017-12-28
腰痛	临床3期	韩国	Kyunghee University Medical Center	2017-12-28