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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical Citrullus colocynthis fruit oil | Active Comparator | Topical Citrullus colocynthis fruit oil (1%) 1 cc twice daily |
|
| Placebo (Vehicle) | Placebo Comparator | Topical vehicle oil 1 cc twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical Citrullus colocynthis fruit oil (1%) | Drug |
| ||
| Topical vehicle oil |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores on the Neuropathic Pain Scale (NPS) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| WHOQOL-BREF Score | 12 weeks | |
| Number of Participants with Adverse Events | 12 weeks | |
| Nerve Conduction Velocity (NCV) (m/sec) of common peroneal nerve (CPN) |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mesbah Shams, M.D. | Research Center for Traditional Medicine & History of Medicine - Shiraz University of Medical Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Physical Medicine and Rehabilitation - Shiraz University of Medical Sciences | Shiraz | Fars | Iran | |||
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| Drug |
|
| 12 weeks |
| NCV (m/sec) of tibial nerve | 12 weeks |
| Distal latency (millisecond) of superficial peroneal nerve (SPN) | 12 weeks |
| Distal latency (millisecond) of sural nerve | 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 |
| Research Center for Traditional Medicine and History of Medicine-Shiraz University of Medical Sciences |
| Shiraz |
| Fars |
| Iran |
| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| D003920 | Diabetes Mellitus |
| D048909 | Diabetes Complications |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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