Clinical trial NCT02155361: Evaluation of Topical Citrullus Colocynthis Fruit Oil Efficacy in Treatment of Painful Peripheral Diabetic Neuropathy
Official title: Evaluation of Topical Citrullus Colocynthis Fruit Oil Efficacy in Treatment of Painful Peripheral Diabetic Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Diabetic Neuropathies
Keywords: Diabetes mellitus
Diabetes complications
Pain
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-06-04
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pain Scores on the Neuropathic Pain Scale (NPS)
timeFrame: 12 weeks
Secondary outcomes:
measure: WHOQOL-BREF Score
timeFrame: 12 weeks
measure: Number of Participants with Adverse Events
timeFrame: 12 weeks
measure: Nerve Conduction Velocity (NCV) (m/sec) of common peroneal nerve (CPN)
timeFrame: 12 weeks
measure: NCV (m/sec) of tibial nerve
timeFrame: 12 weeks
measure: Distal latency (millisecond) of superficial peroneal nerve (SPN)
timeFrame: 12 weeks
measure: Distal latency (millisecond) of sural nerve
timeFrame: 12 weeks
measure: Sensory amplitude (microvolt) of SPN
timeFrame: 12 weeks
measure: Sensory amplitude (microvolt) of sural nerve
timeFrame: 12 weeks
measure: Motor amplitude (microvolt) of CPN
timeFrame: 12 weeks
measure: Motor amplitude (microvolt) of tibial nerve
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Department of Physical Medicine and Rehabilitation - Shiraz University of Medical Sciences
state: Fars
city: Shiraz
country: Iran, Islamic Republic of
facility: Research Center for Traditional Medicine and History of Medicine-Shiraz University of Medical Sciences
state: Fars
Study officials:
affiliation: Research Center for Traditional Medicine & History of Medicine - Shiraz University of Medical Sciences
name: Mesbah Shams, M.D.
role: STUDY_CHAIR
References: