Health Condition 1: E114- Type 2 diabetes mellitus with neurological complications
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants must provide written informed consent to participate in the study. 2. Male and female participants aged between 30 and 60 years. 3. Subjects with a clinical diagnosis of Type 2 diabetes 4. Peripheral neuropathy diagnosed using Semmes-Weinstein Monofilament (SWM) Test and Biothesiometry: 5. Having a history of peripheral neuropathy from onset to 9 years
Exclusion criteria
Exclusion criteria: 1. Subjects with other neurological conditions that affect hand function (e.g., stroke, multiple sclerosis, carpal tunnel syndrome, or someone with excessive alcoholic consumption (more than 21 units per week for men/ more than 15 units for women) will be excluded. 2. Subjects diagnosed with heart disease, renal failure with stage 3 and stage 4, severe hepatic disease, and diabetic foot ulcer. 3. Subjects with type 1 diabetes 4. Subjects with known vitamin B12 deficiency 5. Pregnant, and lactating women will be excluded. 6. Subjects with serious psychiatric disorders, or cognitive impairments that could affect their ability to follow the study protocol will be excluded. 7. Subjects who have had recent surgery or trauma affecting the extremities will be excluded. 8. Those who are participating in any other clinical trial or interventional study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relieve in pain symptoms as per Neuropathic Pain Symptom Inventory scoreTimepoint: 0, 5 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| reductions in scores of Depression, Anxiety, and Stress Scale - 21 Items (DASS-21) weeksTimepoint: 0, 5 weeks;Reductions in worry scores using Penn State Worry QuestionnaireTimepoint: 0, 5 weeks;Enhance in the score of Modified Diabetes Quality of Life scaleTimepoint: 0, 5 weeks;Improvement in Vibration Perception Threshold based on Biothesiometry testTimepoint: 0, 5 weeks;Improved sensory nerve conduction velocity based on mean score of Semmes-Weinstein Monofilament (SWM)Timepoint: 0, 5 weeks;Improved hand grip strength based on the mean score of the TTM Original DynamometerTimepoint: 0, 5 weeks;reduction in FBS and PPBSTimepoint: 0, 5 weeks;Temperature balance in both feetTimepoint: 0, 5 weeks;An open-ended questionnaire will be used for interviews with participants from the Pranic Healing group. The interviews will be recorded, transcribed, and then analyzed.Timepoint: 5 weeks | — |
Countries
India
Contacts
Darlas Health Care