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Topical Citrullus Colocynthis Fruit Oil for Painful Diabetic Neuropathy
NCT02155361Phase 2
Key facts
- Status
- Completed
- Start
- Jun 2014
- Primary completion
- Aug 2014
- Countries
- 1
- Sponsor
- Shiraz University of Medical Sciences
- Modality
- Classical Binding Small Molecules
- Conditions
- diabetic peripheral neuropathy (DPN)
01
Overview
Phase 2, randomised, double-blind trial in diabetic peripheral neuropathy (DPN) comparing Topical Citrullus colocynthis fruit oil with Placebo (Vehicle) (2 arms). Primary endpoint: Neuropathic Pain Scale at 12 weeks. Started Jun 2014; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Topical Citrullus colocynthis fruit oil
Topical Citrullus colocynthis fruit oil (1%) 1 cc twice daily
Placebo (Vehicle)
Topical vehicle oil 1 cc twice daily
03
Endpoints
Primary
Neuropathic Pain Scale
Secondary
World Health Organisation Quality of Life Brief
Number of Participants with Adverse Events
Nerve Conduction Velocity of Common Peroneal Nerve
Nerve Conduction Velocity of Tibial Nerve
Distal Latency of Superficial Peroneal Nerve
Distal Latency of Sural Nerve
Sensory Amplitude of Superficial Peroneal Nerve
Sensory Amplitude of Sural Nerve
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