| Trial ID: | L4578 |
| Source ID: | NCT06131918
|
| Associated Drug: |
Resveratrol, Alpha Lipoic Acid, Super Oxide Dismutase
|
| Title: |
Assessment of Antioxidant Therapy on Oxidative Stress Biomarkers in Type 2 Diabetic Patients With Neuropathy
|
| Acronym: |
RCT
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Peripheral Diabetic Neuropathy
|
| Interventions: |
DRUG: Resveratrol, Alpha lipoic acid, Super oxide dismutase|DRUG: Resveratrol|DRUG: Alpha lipoic acid|DRUG: Super Oxide Dismutase
|
| Outcome Measures: |
Primary: Change in nerve conduction latency, velocity and amplitude., This will be assessed by doing Nerve conduction studies at the start and end of trial. The nerves examined will be Median and Ulnar nerves in upper limb both for motor and sensory conduction. In case of lower limbs motor nerve Peroneal and sensory Sural nerve will be examined., 4 months|Change in clinical symptoms of neuropathy., 1. It will be assessed by Michigan neuropathy screening instrument at the start of the trial, at the end of each month and at the conclusion of the trial. 2. Changes in Quality of life will be assessed by Nottingham health profile. 3. Safety and tolerability of treatment. Recording and evaluation of adverse events and side effects will be done throughout the treatment period, 4 months | Secondary: levels of superoxide radical anion,, Change in the levels of superoxide radical anion, 4 months|Levels of Malonaldehyde oxidative stress biomarker, Change in the levels of oxidative stress biomarkers, 4 months|Levels of Superoxide dismutase and Glutathione peroxidase, Change in the levels of antioxidant enzymes, 4 months
|
| Sponsor/Collaborators: |
Sponsor: Khyber Medical University Peshawar
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
100
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
|
| Start Date: |
2023-01-09
|
| Completion Date: |
2024-05-05
|
| Results First Posted: |
|
| Last Update Posted: |
2024-08-26
|
| Locations: |
Syed Hamid Habib, Peshawar, KPK, Pakistan
|
| URL: |
https://clinicaltrials.gov/show/NCT06131918
|
