Diabetic Neuropathies
Conditions
Keywords
Diabetes mellitus, Diabetes complications, Pain
Brief summary
This study is designed to evaluate the topical Citrullus colocynthis fruit oil efficacy in treatment of painful peripheral diabetic neuropathy (PDN) in a randomized double blind placebo-controlled clinical trial design. This study includes 60 patients from SUMS endocrinology and diabetes clinic. Patients with painful conditions other than PDN such as radiculopathies will be excluded. After giving the Informed consent the patients will be underwent NCS (Nerve Conduction Study) for confirming the diagnosis before recruitment. They will be followed for 12 weeks and after 12 weeks the outcome measures including Neuropathic Pain Scale (NPS), WHOQOL-BREF (World Health Organisation Quality of Life Brief) questionnaire and electrodiagnostic criteria will be evaluated.
Interventions
DRUGTopical Citrullus colocynthis fruit oil (1%)
DRUGTopical vehicle oil
Sponsors
Shiraz University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Controlled type 1 or 2 diabetes mellitus * Painful Peripheral diabetic neuropathy for more than 3 months * Age more than 18 years old * Patients consent on enrolling study and admitting study protocol
Exclusion criteria
* Other causes of pain in lower extremities like lumbar disk herniation * Ulcerative lesions in lower extremities * Dermatitis * Pregnancy * Lactation * Citrullus colocynthis allergy * Unstable cardiac, neurological or renal disease * Diagnosed other types of neuropathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain Scores on the Neuropathic Pain Scale (NPS) | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants with Adverse Events | 12 weeks |
| Nerve Conduction Velocity (NCV) (m/sec) of common peroneal nerve (CPN) | 12 weeks |
| NCV (m/sec) of tibial nerve | 12 weeks |
| Distal latency (millisecond) of superficial peroneal nerve (SPN) | 12 weeks |
| WHOQOL-BREF Score | 12 weeks |
| Sensory amplitude (microvolt) of SPN | 12 weeks |
| Sensory amplitude (microvolt) of sural nerve | 12 weeks |
| Motor amplitude (microvolt) of CPN | 12 weeks |
| Motor amplitude (microvolt) of tibial nerve | 12 weeks |
| Distal latency (millisecond) of sural nerve | 12 weeks |
Countries
Iran
Outcome results
None listed