Efficacy and Safety of Lymphdiaral Basistropfen (a Fixed Homoeopathic Remedy [HDC]) in the Treatment of Chronic Low-back Pain Considering Constitution and Diathesism: a Double Blind, Randomised, Placebo Controlled, Single-centre Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 221
- 试验地点
- 1
- 主要终点
- Change in FFbH-R Between Screening and Week 15
研究概览
简要总结
To evaluate superiority of HDC in comparison to placebo in the treatment of chronic low-back pain in relation to pain, functional impairment, quality of life, and state of health during a 15-week treatment period.
详细描述
Low-back pain is often provoked by inflammatory edema in the region of the facet joints. In naturopathy, a fixed homeopathic drug combination (HDC) is established in the treatment of edema and swellings. For the first time, the efficacy of HDC was investigated in the treatment of low-back pain.
Objective
To examine the efficacy and safety of HDC medication vs. placebo in the treatment of chronic low back pain considering constitution and diathesism in a double-blind, randomized controlled clinical trial.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients
- •Aged 18 - 75 years
- •Chronic low-back pain lasting at least for 6 months
- •Hanover functional ability questionnaire (FFbH-R) score less than 70%
- •At least one of the following diagnoses:
- •Chronic lumbar ischialgia with or without radicular radiation
- •Chronic degenerative lumbar syndrome
- •Spondylarthrosis
- •Chronic facet syndrome
- •Lumbago with protrusion of the intervertebral disc
- •Lumbar radiculopathy
- •Lumbar and other intervertebral disc impairments with radiculopathy
- •Back pain at different locations of the spine
- •Written, informed consent
排除标准
- •Participation in another clinical trial/GCP-trial within 30 days prior to screening
- •Participation in this trial in an earlier time
- •Treatment with lymphdiaral basistropfen within 3 month prior to enrolment
- •Pregnancy and lactation
- •Non-compliance
- •Incapability to understand the sense of the study
- •Abuse of analgesics, opiates or other drugs
- •Chronic pain that are as strong as or even stronger than the pain caused by the low-back and that need to be treated with analgesics
- •Malign diseases
- •Pathological neurological states
- •Operation of the spine within 3 month prior to enrolment
- •Fractures of the spine
- •Bechterew's disease
- •Alcohol abuse
- •Consuming diseases
- •Palsy of the legs or anal sphincter due to acute impairment of the intervertebral disc
- •Catheterisation or CT-controlled intra-articular injection in the lumbar region
- •Hypersensitivity against one of the ingredients or excipients of the study drugs or against composite plants in general
- •Systemic, progressive diseases like tuberculosis, leucosis, collagenosis, multiple sclerosis, acquired immune deficiency syndrome (AIDS), human immunodeficiency virus (HIV) infection, or other auto-immune diseases
研究组 & 干预措施
Lymphdiaral Basistropfen (HDC)
HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks.
干预措施: HDC (Drug)
Placebo Solution
10 drops t.i.d. for 15 weeks
干预措施: Placebo solution (Drug)
结局指标
主要结局
Change in FFbH-R Between Screening and Week 15
时间窗: between screening and 15 weeks treatment
Hannover Functional Questionnaire (FFbH-R) As used in this study test FFbH-R is a special version of the FFbH "for close to everyday diagnostics of functional impairment by back pain". It is a patient questionnaire, which consists of 12 questions for the acquisition of functional limitations consists in activities of daily living. Change in FFbH-R between screening and week 15 Scale ranges from 0 (=worst) to 100(=best)
次要结局
- Change in FFbH-R Between Screening and 2 Weeks(between screening and 2 weeks treatment)
- Change in Pain Score (SES), Subscale "Sensoric Pain"(following 15 weeks treatment)
- Change in Strength of Pain (Visual Analog Scale VAS)(following 15 weeks treatment)
- Change in State of Health (BF-S)(following 15 weeks treatment)
- Change in Oswestry Score(following 15 weeks treatment)
- Change in Short Form Health Survey 12 Items (SF-12)(following 2 weeks treatment)
- Change in Short Form Health Survey 12 Items (SF-12) Ment(following 15 weeks treat)
- Correlation of Efficacy With the Constitutional Type of the Patient, Measured by the Hattinger Constitutional Manual (HKM) and the Hattinger Constitutional Questionnaire (HKF)(following 15 weeks treatment)
- Amount of Analgesics Used(15 weeks treatment)
- Number of Days With Incapability to Work(15 weeks treatment)
- Number of ADRs(within 15 weeks treatment)