Conditions: Low Back Pain
Keywords: low-back pain chronic constitution diathesism homoeopathy fixed combination herbal preparation chronic low back pain lasting more than 6 months
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 221
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: 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. arm 2: 10 drops t.i.d. for 15 weeks

Interventions: intervention 1: HDC intervention 2: Placebo solution
Intervention descriptions: intervention 1: (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),10 drops t.i.d. for 15 weeks. intervention 2: 10 drops, t.i.d, 15 weeks

Protocol document: