Diabetic NeuropathiesPhase 1/2NCT02155361
Evaluation of Topical Citrullus Colocynthis Fruit Oil Efficacy in Treatment of Painful Peripheral Diabetic Neuropathy
A Phase 1/2 study testing Topical Citrullus colocynthis fruit oil (1%) in people with Diabetic Neuropathies, run by Shiraz University of Medical Sciences at 2 sites in Iran.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetic Neuropathies
- What is being tested?
- Topical Citrullus colocynthis fruit oil (1%)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 2 sitesIran
- Study dates
- Jun 2014to Sep 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Iran2 sites
Department of Physical Medicine and Rehabilitation - Shiraz University of Medical Sciences
Shiraz, Fars
Research Center for Traditional Medicine and History of Medicine-Shiraz University of Medical Sciences
Shiraz, Fars
About this study
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.
- Conditions
- Diabetic Neuropathies
- Being tested
- Topical Citrullus colocynthis fruit oil (1%), Topical vehicle oil
- Keywords
- Diabetes mellitus, Diabetes complications, Pain
- Medical subject headings
- Diabetic Neuropathies, Diabetes Mellitus, Diabetes Complications, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Citrullus colocynthis fruit oil (1%)Drug
Topical vehicle oilDrug
| Study group | Role | What they receive |
|---|---|---|
| Topical Citrullus colocynthis fruit oil | Active comparator | Topical Citrullus colocynthis fruit oil (1%) 1 cc twice daily Receives: Drug: Topical Citrullus colocynthis fruit oil (1%) |
| Placebo (Vehicle) | Placebo comparator | Topical vehicle oil 1 cc twice daily Receives: Drug: Topical vehicle oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores on the Neuropathic Pain Scale (NPS)
Measured: 12 weeks
Secondary outcomes (10)
WHOQOL-BREF Score
Measured: 12 weeks
Number of Participants with Adverse Events
Measured: 12 weeks
Nerve Conduction Velocity (NCV) (m/sec) of common peroneal nerve (CPN)
Measured: 12 weeks
NCV (m/sec) of tibial nerve
Measured: 12 weeks
Distal latency (millisecond) of superficial peroneal nerve (SPN)
Measured: 12 weeks
Distal latency (millisecond) of sural nerve
Measured: 12 weeks
Sensory amplitude (microvolt) of SPN
Measured: 12 weeks
Sensory amplitude (microvolt) of sural nerve
Measured: 12 weeks
Motor amplitude (microvolt) of CPN
Measured: 12 weeks
Motor amplitude (microvolt) of tibial nerve
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionAug 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NeuropathiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mesbah Shams, MD, Shiraz University of Medical Sciences
- Investigators
- Mesbah Shams, M.D., Study chair, Research Center for Traditional Medicine & History of Medicine - Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02155361
- Sponsor's protocol ID
- CT-9377-7007
- Status last verified
- Nov 2014
- First submitted
- 31 May 2014
- Last updated
- 17 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Topical Citrullus Colocynthis Fruit Oil Efficacy in Treatment of Painful Peripheral Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT02155361
- Acronym / sponsor ID
- CT-9377-7007
- Conditions
- Diabetic Neuropathies
- Keywords
- Diabetes mellitus, Diabetes complications, Pain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 4 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical Citrullus colocynthis fruit oil | Active comparator | Drug: Topical Citrullus colocynthis fruit oil (1%)Topical Citrullus colocynthis fruit oil (1%) 1 cc twice daily |
| Placebo (Vehicle) | Placebo comparator | Drug: Topical vehicle oilTopical vehicle oil 1 cc twice daily |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Other causes of pain in lower extremities like lumbar disk herniation
- Ulcerative lesions in lower extremities
- Dermatitis
- Pregnancy
- Lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical Citrullus colocynthis fruit oil (1%) | Drug | Topical Citrullus colocynthis fruit oil |
| Topical vehicle oil | Drug | Placebo (Vehicle) |
Primary outcome
Pain Scores on the Neuropathic Pain Scale (NPS)
Time frame: 12 weeks
10 secondary outcomes
WHOQOL-BREF Score
Time frame: 12 weeks
Number of Participants with Adverse Events
Time frame: 12 weeks
Nerve Conduction Velocity (NCV) (m/sec) of common peroneal nerve (CPN)
Time frame: 12 weeks
NCV (m/sec) of tibial nerve
Time frame: 12 weeks
Distal latency (millisecond) of superficial peroneal nerve (SPN)
Time frame: 12 weeks
Distal latency (millisecond) of sural nerve
Time frame: 12 weeks
Sensory amplitude (microvolt) of SPN
Time frame: 12 weeks
Sensory amplitude (microvolt) of sural nerve
Time frame: 12 weeks
Motor amplitude (microvolt) of CPN
Time frame: 12 weeks
Motor amplitude (microvolt) of tibial nerve
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mesbah Shams, M.D. study chair
Research Center for Traditional Medicine & History of Medicine - Shiraz University of Medical Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Topical Citrullus colocynthis fruit oil (1%) in people with Diabetic Neuropathies, run by Shiraz University of Medical Sciences at 2 sites in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Scores on the Neuropathic Pain Scale (NPS) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2014.