Type II Diabetic Mellitus Neuropathic Pain Painful Diabetic Peripheral Neuropathy (PDPN) Peripheral Nervous System Diseases Neuralgia Neuralgia Pain Neuromuscular Diseases Nervous System Diseases Neurologic Manifestations Diabetes Complications Diabetes Mellitus Endocrine System Diseases
Conditions
Interventions
Drug: transdermal medical cannabis (THC:CBD formulas),Drug: Placebo (Coconut oil extract)
Active Comparator Drug,Placebo Comparator Drug
Transdermal medical cannabis (THC: CBD formulas),Placebo (Coconut oil extract)
Sponsors
Faculty of Medicine, Khon Kaen University
Eligibility
Sex/Gender
All
Age
20 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Established diagnosis of diabetes II with painful diabetic peripheral neuropathy and glycosylated haemoglobin, HbA1c less than 11% at screening. 2. Stable glycemic control, HbA1c less than 11% achieved by a drug regimen for at least three months prior to screening. 3. At least a 1-year history of painful diabetic peripheral neuropathy. 4. Subjects must be over 20 years of age, Male and Female. 5. Subjects had painful diabetic peripheral neuropathy as measured using the Neuropathic Pain Symptom Inventory (NPSI) criteria. 6. The subjects were undergoing treatment under the supervision of a physician. They were treated with hypoglycemic drugs and had stable disease symptoms at least 12 weeks before the start of the study. 7. Subjects had painful diabetic peripheral neuropathy who had severity ranging from mild, moderate, and severe. 8. The Subjects did not use other drugs that affect pain caused by diabetic neuropathy. 9. Who had been treated for peripheral neuropathy but were unsuccessful with other treatments. 10. The Subjects were treated not inferior to standard care. Who was able to adjust the dose as appropriate in the amount that could treat the sciatic nerve pain and must tell the number of doses used so that the researchers can record and use the results to evaluate the product's effectiveness. 11. Subjects can listen to clarifications on the practice of medical cannabis use. Have an understanding of the clinical trial process, Cooperation in attending physical examinations by appointment, and the clinical trial process according to the practice guidelines of the trial until the completion of the process. 12. Subjects can provide information. Furthermore, express consent to clinical trials by voluntary written consent as a volunteer at the beginning of the trial.
Exclusion criteria
Exclusion criteria: 1. Cerebrovascular events or other neurological illnesses in the past. 2. Subjects with other pathological conditions including cirrhosis, hepatitis, Hepatic carcinoma, cancer, HIV, AIDS, CKD end-stage. 3. Serious illnesses were precluding the gathering of or potentially impacting primary and secondary outcome measures, for example, major organ failure, neoplasia, or coeliac disease. 4. The subjects used various forms of medicinal cannabis products at least three months prior to the trial. They did not stop using medical cannabis prior to the study: Moreover, they were known or suspected hypersensitivity to cannabinoids or any of the excipients of the study medications. 5. Subjects treated with antidepressants, Tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors (SNRIs), calcium channel blockers, opioids, Tramadol, and other drugs that affect nerve pain such as Capsaicin cream, Lidocaine cream, or patch before the start of the trial and had stopped taking the drugs at least 3 months before the start of the study. 6. Subjects who received anti-seizure drugs and other drugs that reduce nerve pain. before the start of the study and had stopped taking the drug at least three months before the start of the study. 7. Subjects who have been planning surgery are Currently undergoing rehabilitation after neurosurgery to treat herniated disc pain. 8. Subjects with nerve damage caused by other causes such as cancer, central nervous system accidents. and peripheral nervous system. 9. After entering a research study, subjects do not voluntarily continue to volunteer for the duration of the study. 10. Subjects with a medical history and family history of psychiatric disorders such as schizophrenia, bipolar disorder, chronic depression, suicidal ideation, and psychosis. 11. Current or history of substance abuse. 12. Subjects who underwent medical examinations were discovered to have physical abnormalities such as deformities, diabetic foot ulcers, or other abnormalities that the medical practitioner determined prevented them from participating in the research to assure the sample group's safety. 13. Subjects who had an amputation due to diabetic nerve injury before enrolling in the trial. 14. During the trial, women who were pregnant, breastfeeding, or planned to become pregnant were excluded. 15. Subjects who intend to go beyond the area or who were not in the area throughout the 12-week research period. 16. The patient's cognitive impairment is severe enough that he or she cannot give informed consent. 17. Subjects are suspected or confirmed patients of coronavirus 2019 infection who'll be investigated and monitored for the spread of the disease for 14-21 days. 18. Subjects are undergoing other research studies treated or treated for diabetic peripheral neuropathy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| average pain intensity From Screening (Baseline data Day 0) and 24 hrs post-dose and at 4, 8, 12 weeks to End of Study Visit (12 weeks Neuropathic Pain Symptom Inventory (NPSI) ,pain symptoms From Screening (Baseline data Day 0) and 24 hrs post-dose and at 4, 8, 12 weeks to End of Study Visit (12 weeks Neuropathic Pain Symptom Inventory (NPSI) | — |
Secondary
| Measure | Time frame |
|---|---|
| safety, tolerability and side effect From Screening (Baseline data Day 0) and 24 hrs post-dose and at 4, 8, 12 weeks to End of Study Visit (12 weeks Grading Dermatologic Adverse Events in Clinical Trials Using CTCAE v4.0 and HPVC Form 1. ,Quality of life From Screening (Baseline data Day 0) and 24 hrs post-dose and at 4, 8, 12 weeks to End of Study Visit (12 weeks Health-related quality of life measure (EQ-5D-5L) ,neurophysiology From Screening (Baseline data Day 0) and 24 hrs post-dose and at 4, 8, 12 weeks to End of Study Visit (12 weeks sensory and motor nerve function to the lower limbs.,Intention-to-treat analysis From Screening (Baseline data Day 0) and 24 hrs post-dose and at 4, 8, 12 weeks to End of Study Visit (12 weeks Responder rate | — |
Countries
Thailand
Contacts
Public ContactKhachornsak Seevathee
Donchan hospital, Kalasin Provincial Public Health Office, Ministry Of Public Health, Thailand
Outcome results
None listed