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NCT Number: NCT02155361

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

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.

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Key information

Conditions

Diabetic Neuropathies Diabetes Complications Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Nutritional and Metabolic Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Department of Physical Medicine and Rehabilitation - Shiraz University of Medical Sciences, Shiraz, Fars, Iran

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Topical Citrullus colocynthis fruit oil (1%)

Drug

Topical vehicle oil

Drug

Primary outcomes

  1. Pain Scores on the Neuropathic Pain Scale (NPS)

    Time frame: 12 weeks

Secondary outcomes

  1. WHOQOL-BREF Score

    Time frame: 12 weeks

  2. Number of Participants with Adverse Events

    Time frame: 12 weeks

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

    Time frame: 12 weeks

  4. NCV (m/sec) of tibial nerve

    Time frame: 12 weeks

  5. Distal latency (millisecond) of superficial peroneal nerve (SPN)

    Time frame: 12 weeks

  6. Distal latency (millisecond) of sural nerve

    Time frame: 12 weeks

  7. Sensory amplitude (microvolt) of SPN

    Time frame: 12 weeks

  8. Sensory amplitude (microvolt) of sural nerve

    Time frame: 12 weeks

  9. Motor amplitude (microvolt) of CPN

    Time frame: 12 weeks

  10. Motor amplitude (microvolt) of tibial nerve

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Shiraz University of Medical Sciences

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 4, 2014
Registry last updated
Nov 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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