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

Phase 1

Completed

• Conditions: Diabetic Neuropathies
• Interventions: Drug: Topical Citrullus colocynthis fruit oil (1%); Drug: Topical vehicle oil

• Registration Number: NCT02155361
• Lead Sponsor: Shiraz University of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-31
• Study Start: 2014-06
• Study First Submitted QC: 2014-06-02
• Study First Posted: 2014-06-04
• Primary Completion: 2014-08
• Study Completion: 2014-09
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-14
• Last Update Posted: 2014-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Topical Citrullus colocynthis fruit oil	Topical Citrullus colocynthis fruit oil (1%)	Topical Citrullus colocynthis fruit oil (1%) 1 cc twice daily
Placebo (Vehicle)	Topical vehicle oil	Topical vehicle oil 1 cc twice daily

Primary Outcome Measures

Name	Time	Method
Pain Scores on the Neuropathic Pain Scale (NPS)	12 weeks

Secondary Outcome Measures

Name	Time	Method
Sensory amplitude (microvolt) of SPN	12 weeks
Nerve Conduction Velocity (NCV) (m/sec) of common peroneal nerve (CPN)	12 weeks
Motor amplitude (microvolt) of tibial nerve	12 weeks
Distal latency (millisecond) of sural nerve	12 weeks
WHOQOL-BREF Score	12 weeks
Number of Participants with Adverse Events	12 weeks
Sensory amplitude (microvolt) of sural nerve	12 weeks
NCV (m/sec) of tibial nerve	12 weeks
Distal latency (millisecond) of superficial peroneal nerve (SPN)	12 weeks
Motor amplitude (microvolt) of CPN	12 weeks

Trial Locations

Locations (2)

Research Center for Traditional Medicine and History of Medicine-Shiraz University of Medical Sciences; 🇮🇷 Shiraz, Fars, Iran, Islamic Republic of

Department of Physical Medicine and Rehabilitation - Shiraz University of Medical Sciences; 🇮🇷 Shiraz, Fars, Iran, Islamic Republic of