Health Condition 1: G63- Polyneuropathy in diseases classified elsewhere
Conditions
Interventions
Intervention1: Naturally Medicated Socks: Socks contain Natural Micron Copper, Activated Carbon, Bio Polymer Nano Membrane and Knitted Fabric.
Socks are to be worn on clean dry feet every night and
Sponsors
Goodway Indsol Pvt. Ltd.
Yellow Bricks Research Hub
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults aged greater than 40 years (all genders) with confirmed history of diabetes mellitus (type I OR II) 2. Subjects with peripheral neuropathy symptoms below the ankle (numbness, tingling, burning, sharp pain, increased sensitivity, etc.) 3. Subjects who have scored greater than or equal to three in modified Toronto Clinical Neuropathy Score. 4. Subjects who are able to walk independently without an assistance device. 5. Subjects with DN4 score of greater than 4 by 10 at the time of screening. 6. Subjects with berg balance scale score between 21 and 40 at the time of screening. 7. Subjects who are willing to abstain from the use of herbal, allopathic medicines not limited to oils, ointments, topical analgesics or anesthetics, rubefacients or any other dressings, bandages or wraps that are intended towards the management or improvement of peripheral neuropathic symptoms. 8. Subjects who are willing to refrain from massages (home or professional services) not limited to panchakarma, moxibustion, cupping etc for the duration of the study. 9. Subjects who are willing to refrain from use of any specialized footwear that are aimed at improving peripheral neuropathic symptoms. 10. Subjects who are willing to give informed consent for participation, able to comprehend and understand the responsibilities during screening and treatment period. 11. Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
Exclusion criteria
Exclusion criteria: 1. Subjects with peripheral neuropathy, ulcers and gangrene of the limbs caused by a variety of other reasons (e.g. hypothyroidism, alcohol, drugs, heredity, etc.), or persons with a history of skin ulcers or lesions that do not heal easily. 2. Subjects who are currently undergoing physical therapy, acupressure, acupuncture therapies. 3. Subjects who have unhealed diabetic foot ulcers, venous ulcers or have had an ulcer completely heal less than 30 days prior to screening. 4. Subjects with neurological illness and or active ear infections that impact balance. 5. Subjects who are amputees and or have had any surgery of the lower limb upto 6 months prior to screening. 6. Subjects who are malnourished, underweight as per BMI or have lost greater than 5 percentage body weight in less than 30 days prior to screening. 7. Subjects who have skin conditions, scarring or other conditions of the lower extremities that may impact the evaluation of the study product and or assessment by the investigator. 8. Subjects who have an active infection, disease or disorder that will prevent them from fully satisfying the responsibilities of the study. 9. Subjects with history of seizures, uncontrolled diabetes, hypertension or major cardiac illness like congestive heart failure etc. 10. Subjects on remission from cancer of any type less than 5 years at the time of screening 11. Subjects who are planning a pregnancy and or currently breastfeeding. 12. Subjects who have participated in a clinical study less than 1 month before screening. 13. Any significant medical condition (e.g., significant psychiatric or neurological disorders, active alcohol or drug abuse, etc.), any medical condition that is unstable or poorly controlled or other factor (e.g., planned relocation) that the Investigator felt would interfere with study evaluations and study participation. 14. Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol. 15. Subjects, who in the opinion of the investigator are not eligible for enrolment in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Pain Numerical Rating Scale : Reduction of greater than 30% from baseline. 2.m-Toronto Clinical Neuropathy Scoring System : Reduction of greater than 20% from baseline. 3.Berg Balance Scale : Increase of 5 scores from baseline. 4.Timed Up and Go Test : Time taken to be less than10 seconds by end of study. 5.Neuropathic Pain Scale : Reduction of greater than 30% from baseline. 6.Ankle Circumference : Reduction of greater than 6% from baseline. 7.Product Feedback Questionnaire : Score of greater than 30 at end of the study. 8.Product Feedback Questionnaire : Score of greater than 50 at end of the study. Timepoint: 1.Pain Numerical Rating Scale : Day 1, Day 15, Day 30 2.m-Toronto Clinical Neuropathy Scoring System : Day 1, Day 15, Day 30 3.Berg Balance Scale : Day 1, Day 15, Day 30 4.Timed Up and Go Test : Day 1, Day 15, Day 30 5.Neuropathic Pain Scale : Day 1, Day 15, Day 30 6.Ankle Circumference : Day 1, Day 15, Day 30 7.Product Feedback Questionnaire : Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactDr VT Sriraam
Yellow Bricks Research Hub (A Unit of Aurous HealthCare R&D India Pvt. Ltd.)
Outcome results
None listed