NCT02155361

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2014

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

November 17, 2014

Status Verified

November 1, 2014

Enrollment Period

2 months

First QC Date

May 31, 2014

Last Update Submit

November 14, 2014

Conditions

Diabetic Neuropathies

Keywords

Diabetes mellitusDiabetes complicationsPain

Outcome Measures

Primary Outcomes (1)

  • Pain Scores on the Neuropathic Pain Scale (NPS)

    12 weeks

Secondary Outcomes (10)

  • WHOQOL-BREF Score

    12 weeks

  • Number of Participants with Adverse Events

    12 weeks

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

    12 weeks

  • NCV (m/sec) of tibial nerve

    12 weeks

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

    12 weeks

  • +5 more secondary outcomes

Study Arms (2)

Topical Citrullus colocynthis fruit oil

ACTIVE COMPARATOR

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

Drug: Topical Citrullus colocynthis fruit oil (1%)

Placebo (Vehicle)

PLACEBO COMPARATOR

Topical vehicle oil 1 cc twice daily

Drug: Topical vehicle oil

Interventions

Topical Citrullus colocynthis fruit oil (1%)DRUG
Topical Citrullus colocynthis fruit oil
Topical vehicle oilDRUG
Placebo (Vehicle)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Shiraz, Fars, Iran

Location

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

Shiraz, Fars, Iran

Location

MeSH Terms

Conditions

Diabetic NeuropathiesDiabetes MellitusDiabetes ComplicationsPain

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mesbah Shams, M.D.

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Mesbah Shams

Study Record Dates

First Submitted

May 31, 2014

First Posted

June 4, 2014

Study Start

June 1, 2014

Primary Completion

August 1, 2014

Study Completion

September 1, 2014

Last Updated

November 17, 2014

Record last verified: 2014-11

Locations

IR(2)