Health Condition 1: E114- Type 2 diabetes mellitus with neurological complications
Conditions
Interventions
Intervention1: Kalonji (Nigella sativa): powdered kalonji in capsules 500mg - 2capsules thrice a day
Oral route for 6weeks
Control Intervention1: Wheat flour: 500 grams capsule 2capsules thrice a day
Sponsors
Government of TamilNadu
Eligibility
Inclusion criteria
Inclusion criteria: Presence of type 2 diabetes mellitus Type 2 DM patients diagnosed with DPN for at least one month and blood glucose stabilized with antidiabetic medications were included in the study. Symptoms such as numbness, tingling sensation, burning pain, excruciating stabbing type of pain, paraesthesia, and hyperesthesia coupled with deep aching in feet or hands. Impaired pinprick, temperature or vibration sensation in both feet and absent or reduced ankle reflexes. HbA1C Levels less than 11percent Ability to provide informed consent and comply with study procedures. Diabetic Neuropathy Symptom score (DNS Score more than 1)
Exclusion criteria
Exclusion criteria: HbA1C More than 11 percent History of allergy or intolerance to kalonji or any of its components Other complications like Nephropathy and Retinopathy. Use of medications known to significantly affect nerve function (e.g., chemotherapeutic agents, immunosuppressants). Diabetic patients with serious acute and chronic complications, such as diabetic ketoacidosis, etc Pregnancy or lactation women They had a severe illness in one of their vital organs such as their livers or kidneys (GFR less than 30 ml per min) or other organs. Unstable, bedridden and mentally retarded patients. Alcohol abusers and drug addicts. Neuropathic pain is not caused by PDN (e.g., malignant tumours, vitamin B12 deficiency, hypothyroidism, neurotoxic drug therapy, etc)
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| To assess the effects of kalonji (Nigella sativa) on changes in Michigan Neuropathy Screening Instruments (MNSI) and Vibration Perception Threshold (VPT) Timepoint: Baseline, 1st week ,2nd week, 4 th week , 6th week | — |
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of kalonji in improving in Signs and symptoms of Diabetic Neuropathy based on severity in Neuropathy Disability Score. Timepoint: Baseline, 1st week ,2nd week, 4 th week , 6th week | — |
Countries
India
Contacts
Public ContactDr Mubasheera Begum
Government Unani Medical College Chennai
Outcome results
None listed