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

Primary Purpose

Diabetic Neuropathies

Status
Completed
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Topical Citrullus colocynthis fruit oil (1%)
Topical vehicle oil
Sponsored by
Shiraz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Neuropathies focused on measuring Diabetes mellitus, Diabetes complications, Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Physical Medicine and Rehabilitation - Shiraz University of Medical Sciences
  • Research Center for Traditional Medicine and History of Medicine-Shiraz University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Topical Citrullus colocynthis fruit oil

Placebo (Vehicle)

Arm Description

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

Topical vehicle oil 1 cc twice daily

Outcomes

Primary Outcome Measures

Pain Scores on the Neuropathic Pain Scale (NPS)

Secondary Outcome Measures

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

Full Information

First Posted
May 31, 2014
Last Updated
November 14, 2014
Sponsor
Shiraz University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02155361
Brief Title
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

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shiraz University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathies
Keywords
Diabetes mellitus, Diabetes complications, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Topical Citrullus colocynthis fruit oil
Arm Type
Active Comparator
Arm Description
Topical Citrullus colocynthis fruit oil (1%) 1 cc twice daily
Arm Title
Placebo (Vehicle)
Arm Type
Placebo Comparator
Arm Description
Topical vehicle oil 1 cc twice daily
Intervention Type
Drug
Intervention Name(s)
Topical Citrullus colocynthis fruit oil (1%)
Intervention Type
Drug
Intervention Name(s)
Topical vehicle oil
Primary Outcome Measure Information:
Title
Pain Scores on the Neuropathic Pain Scale (NPS)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
WHOQOL-BREF Score
Time Frame
12 weeks
Title
Number of Participants with Adverse Events
Time Frame
12 weeks
Title
Nerve Conduction Velocity (NCV) (m/sec) of common peroneal nerve (CPN)
Time Frame
12 weeks
Title
NCV (m/sec) of tibial nerve
Time Frame
12 weeks
Title
Distal latency (millisecond) of superficial peroneal nerve (SPN)
Time Frame
12 weeks
Title
Distal latency (millisecond) of sural nerve
Time Frame
12 weeks
Title
Sensory amplitude (microvolt) of SPN
Time Frame
12 weeks
Title
Sensory amplitude (microvolt) of sural nerve
Time Frame
12 weeks
Title
Motor amplitude (microvolt) of CPN
Time Frame
12 weeks
Title
Motor amplitude (microvolt) of tibial nerve
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mesbah Shams, M.D.
Organizational Affiliation
Research Center for Traditional Medicine & History of Medicine - Shiraz University of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Physical Medicine and Rehabilitation - Shiraz University of Medical Sciences
City
Shiraz
State/Province
Fars
Country
Iran, Islamic Republic of
Facility Name
Research Center for Traditional Medicine and History of Medicine-Shiraz University of Medical Sciences
City
Shiraz
State/Province
Fars
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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