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

Shiraz University of Medical Sciences70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Diabetic Neuropathies

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (2)

Department of Physical Medicine and Rehabilitation - Shiraz University of Medical Sciences

Shiraz, Fars, Iran

Research Center for Traditional Medicine and History of Medicine-Shiraz University of Medical Sciences

Shiraz, Fars, Iran

Outcomes

Primary Outcomes

Pain Scores on the Neuropathic Pain Scale (NPS)

Time frame: 12 weeks

Secondary Outcomes

WHOQOL-BREF Score

Time frame: 12 weeks

Number of Participants with Adverse Events

Time frame: 12 weeks

Nerve Conduction Velocity (NCV) (m/sec) of common peroneal nerve (CPN)

Time frame: 12 weeks

NCV (m/sec) of tibial nerve

Time frame: 12 weeks

Distal latency (millisecond) of superficial peroneal nerve (SPN)

Time frame: 12 weeks

Distal latency (millisecond) of sural nerve

Time frame: 12 weeks

Sensory amplitude (microvolt) of SPN

Time frame: 12 weeks

Sensory amplitude (microvolt) of sural nerve

Time frame: 12 weeks

Motor amplitude (microvolt) of CPN

Time frame: 12 weeks

Motor amplitude (microvolt) of tibial nerve

Time frame: 12 weeks