Evaluation of Topical Citrullus Colocynthis Fruit Oil Efficacy in Treatment of Painful Peripheral Diabetic Neuropathy

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Topical Citrullus Colocynthis Fruit Oil Efficacy in Treatment of Painful Peripheral Diabetic Neuropathy

Conditions
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Diabetic Neuropathies

Intervention / Treatment
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* Drug: Topical Citrullus colocynthis fruit oil (1%)
* Drug: Topical vehicle oil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Topical Citrullus colocynthis fruit oil<br>Topical Citrullus colocynthis fruit oil (1%) 1 cc twice daily | Drug: Topical Citrullus colocynthis fruit oil (1%)<br> <br> |
| Placebo Comparator: Placebo (Vehicle)<br>Topical vehicle oil 1 cc twice daily | Drug: Topical vehicle oil<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores on the Neuropathic Pain Scale (NPS) |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes mellitus, Diabetes complications, Pain