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A clinical trial of Diosmin's effects in the treatment of low back pain

A randomized controlled trial evaluating the effects of Diosmin in the treatment of radicular pain caused by lumbar intervertebral disc protrusion

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN97157037
Enrollment
300
Registered
2017-06-13
Start date
2009-01-01
Completion date
Unknown
Last updated
2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radicular pain Signs and Symptoms Radicular pain

Interventions

Participants are randomised to one of two groups using a single randomisation technique. Intervention group: Participants receive Diosmin (Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd) per os, 9

Sponsors

Nanjing Drum Tower Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Preliminarily diagnosis of radicular pain 2. Aged 18 years and over 3. Pain duration at least 30 days 4. Underwent routine discography 5. Previously treated with nonsteroidal anti-inflammatory drugs, opioid medications or physical therapy without pain relief for more than one month 6. Normal or slight decrease in the height of disc space on lateral plain X-ray film 7. Initially considered eligible for surgical intervention

Exclusion criteria

Exclusion criteria: 1. Spondylolysis 2. Lumbar canal stenosis 3. Isthmic or degenerative spondylolisthesis 4. Inflammatory arthritis 5. Spinal instability 6. Infection from previous lumbar surgery 7. Neurologic disease 8. Tumor 9. Psychological disorders (such as depression or using antidepressant/anxiolytic medications)

Design outcomes

Primary

MeasureTime frame
1. Perceived pain is measured using a visual analogue scale (VAS) and a numerical rating scale (NRS) just after the administration of drugs, and two and eight weeks later 2. Self-rated physical disability is measured using the Roland-Morris questionnaire (RM-Q) just after the administration of drugs, and two and eight weeks later

Secondary

MeasureTime frame
Patient’s satisfaction is measured using a three-grade scale ranging from completely satisfied (no pain at all time and no restriction of activities) to satisfied (slight pain that requires no medication and mild restriction of activities) to unsatisfied (moderate to severe pain that requires medication and moderate to severe restriction of activities) via telephone after two years.

Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 27, 2026