NCT03132974Unknown2 期
Evaluation of Efficacy and Safety of Single and Multiple Therapy of Herbal Medicine/Chuna Therapy on Non-specific Chronic Low Back Pain: A Study Protocol for Multicenter, 3-arm, Randomized, Single Blinded, Parallel Group, Incomplete Factorial Design, Pilot Study -
Gachon University Gil Oriental Medical Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2018年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change from Baseline in Numeric Rating Scale of Pain
研究概览
简要总结
The Purpose of this trial is to investigate the efficacy and safety of herbal medicine with manipulation therapy on Korean Patients with Chronic Low Back Pain
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatients with chief complaint of low back pain in oriental rehabilitation medical center
- •Age 19 - 65
- •Patients who have 4 ~7 cm of VAS pain score;
- •Ability to have normal communication
- •Ability to give informed consent
排除标准
- •Patients with pain duration of 3 months or less
- •Patients with progressive neurologic deficit or severe neurologic symptoms by SLR test
- •Patients diagnosed with serious pathology(s) which may cause low back pain (e.g. spinal metastasis of tumor(s), acute fracture, etc)
- •Patients with spondylolisthesis or spondylolysis(diagnosed with grade II or higher level)
- •Patients currently taking steroids, immunosuppressants, medicine for mental illness or other medication(s) that may interfere with study results
- •Patients with history of spinal surgery
- •Patients with more severe pain than pain caused by low back pain
- •Those who do not (cannot) abide by treatment and follow up due to the mental illness such as behavior disorder, depression, anxiety neurosis etc.
- •Patients with history of Medical Malpractice Case
- •Patients with treatment history of low back pain within 1 month either KM or WM
- •Patients participating in other clinical studies within 3 months
- •Pregnant patients or patients with plans of pregnancy or lactating patients
- •Patients disagree to sign the informed consent form
- •Patients deemed unsuitable for participating the trial by the researchers
研究组 & 干预措施
SGHH
Experimental
Admission to Sogyeonghwalhyeol-tang granule
干预措施: Sogyeonghwalhyeol-tang granule (Drug)
SGHH with manipulation therapy
Experimental
Admission to Sogyeonghwalhyeol-tang granule and manipulation therapy
干预措施: Sogyeonghwalhyeol-tang granule with manipulation procedure (Other)
Placebo with manipulation therapy
Placebo Comparator
干预措施: Placebo with manipulation procedure (Other)
结局指标
主要结局
Change from Baseline in Numeric Rating Scale of Pain
时间窗: Screening Visit, At baseline, week 2, 4, 6, 8
A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) assesses the patients' current level of pain.
次要结局
- Change from Baseline in 'Roland Morris Disability Questionnaire'(Screening Visit, At baseline, week 2, 4, 6, 8)
- Change from Baseline in European Quality of life 5 Dimension(Screening Visit, At baseline, week 2, 4, 6, 8)
研究者
Yun-Kyung Song
PhD
Gachon University Gil Oriental Medical Hospital
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety of Traditional Chinese Medicine Intervention for Women With Menopausal SyndromeMenopausal SyndromeNCT00933725Guangzhou University of Traditional Chinese Medicine194
已完成
1 期
Safety and Efficacy of a Natural Health Product in Reducing Cholesterol and Triglyceride Levels.LDL CholesterolTriglyceridesNCT01028274Nordic Pharma, USA148
已完成
4 期
Evaluation of the Efficacy and Safety of Herbal Medicine for Treating Work-related Chronic Low Back PainLow Back PainWorkplaceNCT02988232Gachon University Gil Oriental Medical Hospital72
已完成
2 期
A Clinical Trial on the Efficacy of a Combination Herbal Product, Biotropics' Nu Femme, on Menopausal Symptoms and Quality of Life in WomenMenopausal SymptomsNCT02269891KGK Science Inc.119
招募中
不适用
Evaluation efficacy of a herbal combination (contains Glycyrrhiza glabra, Mentha pulegium and Urtica) in controlling symptoms in patients with COVID-19IRCT20080901001165N49Andisheh Salamat Sabalan Medicinal Plants Company80