Use of Propolis in gel for Diabetic Polyneuropathy: clinical and neurophysiological evaluation in a clinical trial

Use of Propolis tincture in transdermal gel for Diabetic Polyneuropathy: clinical and neurophysiological evaluation in a randomized double-blind clinical trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-8wpzd78

Enrollment

Registered

2026-07-28

Start date

2027-01-20

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Neuropathies

Interventions

This is a two-arm, double-blind, randomized controlled clinical trial. Participants will be randomly allocated in a 1:1 ratio to one of two study groups using computer-generated randomization. The tri

Eligibility

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients with type 2 Diabetes Mellitus; aged 18 to 80 years; both sexes; prior diagnosis of mild or moderate diabetic polyneuropathy according to the criteria of the Brazilian Diabetes Society and the Neuropathy Disability Score

Exclusion criteria

Exclusion criteria: Patients whose sensory potential is abolished during neurophysiological study, patients who have undergone limb amputations, with active ulcers on the lower limbs, those with recent use of other topical treatments on the feet, and patients with a known allergy to propolis or other bee products

Design outcomes

Primary

Measure	Time frame
Improvements in the neurophysiological parameters of diabetic polyneuropathy are expected, assessed by nerve conduction studies using electroneuromyography, through analysis of the amplitude and velocity of sensory action potentials and the amplitude of the cutaneous-sympathetic reflex. Data will be collected before the start of the intervention and after eight weeks of treatment	—

Secondary

Measure	Time frame
It is expected that a reduction in the intensity of neuropathic pain, assessed by the Visual Analogue Scale and the Brief Pain Inventory, will be observed; improvement in neuropathic symptoms, assessed by the Michigan Neuropathy Screening Instrument, the Douleur Neuropathique 4 Questions, and the Leeds Assessment of Neuropathic Symptoms and Signs; improvement in neurological impairment, assessed by the Neuropathy Disability Score and the Modified Toronto Clinical Neuropathy Score; improvement in tactile sensitivity, assessed by Semmes-Weinstein monofilaments; and improvement in vibratory sensitivity, assessed by a 128 Hz tuning fork. All outcomes will be assessed before the start of the intervention and after eight weeks of treatment	—

Measure

Time frame

It is expected that a reduction in the intensity of neuropathic pain, assessed by the Visual Analogue Scale and the Brief Pain Inventory, will be observed; improvement in neuropathic symptoms, assessed by the Michigan Neuropathy Screening Instrument, the Douleur Neuropathique 4 Questions, and the Leeds Assessment of Neuropathic Symptoms and Signs; improvement in neurological impairment, assessed by the Neuropathy Disability Score and the Modified Toronto Clinical Neuropathy Score; improvement in tactile sensitivity, assessed by Semmes-Weinstein monofilaments; and improvement in vibratory sensitivity, assessed by a 128 Hz tuning fork. All outcomes will be assessed before the start of the intervention and after eight weeks of treatment

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Countries

Contacts

Public ContactSamila Gomes

Universidade do Estado do Rio Grande do Norte, Faculdade de Ciências da Saúde (FACS)

samilamarissa@gmail.com+55 (84) 3315-2248

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Aug 10, 2026