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

Diabetic Neuropathies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02155361
• Other study ID #: CT-9377-7007
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 31, 2014
• Last updated: November 14, 2014
• Start date: June 2014
• Est. completion date: September 2014

Study information

• Verified date: November 2014
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Neuropathies

Intervention

Drug:
• Topical Citrullus colocynthis fruit oil (1%)

• Topical vehicle oil

Locations

Country	Name	City	State
Iran, Islamic Republic of	Department of Physical Medicine and Rehabilitation - Shiraz University of Medical Sciences	Shiraz	Fars
Iran, Islamic Republic of	Research Center for Traditional Medicine and History of Medicine-Shiraz University of Medical Sciences	Shiraz	Fars

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Scores on the Neuropathic Pain Scale (NPS)		12 weeks	No
Secondary	WHOQOL-BREF Score		12 weeks	No
Secondary	Number of Participants with Adverse Events		12 weeks	Yes
Secondary	Nerve Conduction Velocity (NCV) (m/sec) of common peroneal nerve (CPN)		12 weeks	No
Secondary	NCV (m/sec) of tibial nerve		12 weeks	No
Secondary	Distal latency (millisecond) of superficial peroneal nerve (SPN)		12 weeks	No
Secondary	Distal latency (millisecond) of sural nerve		12 weeks	No
Secondary	Sensory amplitude (microvolt) of SPN		12 weeks	No
Secondary	Sensory amplitude (microvolt) of sural nerve		12 weeks	No
Secondary	Motor amplitude (microvolt) of CPN		12 weeks	No
Secondary	Motor amplitude (microvolt) of tibial nerve		12 weeks	No