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

Shiraz University of Medical Sciences

Status and phase: Completed; Phase 2; Phase 1

Conditions: Diabetic Neuropathies

Treatments: Drug: Topical vehicle oil; Drug: Topical Citrullus colocynthis fruit oil (1%)

Study type: Interventional

Funder types: Other

Identifiers

NCT02155361

CT-9377-7007

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups, including a placebo group

Topical Citrullus colocynthis fruit oil

Active Comparator group

Description:

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

Treatment:

Drug: Topical Citrullus colocynthis fruit oil (1%)

Placebo (Vehicle)

Placebo Comparator group

Description:

Topical vehicle oil 1 cc twice daily

Treatment:

Drug: Topical vehicle oil