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

NCT ID: NCT02155361

Last Updated: 2014-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2014-09-30

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.

Detailed Description

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Conditions

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Diabetic Neuropathies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Topical Citrullus colocynthis fruit oil

Topical Citrullus colocynthis fruit oil (1%) 1 cc twice daily

Group Type ACTIVE_COMPARATOR

Topical Citrullus colocynthis fruit oil (1%)

Intervention Type DRUG

Placebo (Vehicle)

Topical vehicle oil 1 cc twice daily

Group Type PLACEBO_COMPARATOR

Topical vehicle oil

Intervention Type DRUG

Interventions

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Topical Citrullus colocynthis fruit oil (1%)

Intervention Type DRUG

Topical vehicle oil

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shiraz University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Mesbah Shams, MD

Dr. Mesbah Shams

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mesbah Shams, M.D.

Role: STUDY_CHAIR

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

Locations

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

Shiraz, Fars, Iran

Site Status

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

Shiraz, Fars, Iran

Site Status

Countries

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Iran

Other Identifiers

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CT-9377-7007

Identifier Type: -

Identifier Source: org_study_id