CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 100 enrolled
Drug / intervention
Resveratrol, Alpha lipoic acid, Super oxide dismutase +3 moredrug
Likely dose
Resveratrol, Alpha lipoic acid, Super oxide dismutase 1500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06131918
NCT06131918Phase 2Completed

Assessment of Resveratrol, Alpha Lipoic Acid and Superoxide Dismutase on Oxidative Stress Biomarkers in Type 2 Diabetes Mellitus Patients With Neuropathy: A Randomized Control Trial

Khyber Medical University Peshawar·interventional·Posted Nov 14, 2023·Updated Aug 26, 2024

In Brief

A Phase 2 clinical trial evaluating Resveratrol, Alpha lipoic acid, Super oxide dismutase, Resveratrol, and 2 other interventions for Peripheral Diabetic Neuropathy. Completed, enrolled 100 participants across 1 site.

Detailed Summary

Type 2 DM subjects having numbness, tingling and paresthesia in hands and feet (neuropathy) will be recruited. Screening of neuropathy will be done by Michigan screening instrument. This will be followed by nerve conduction studies. Specific blood parameters will also be checked. The subjects will then be divided into four treatment arms. Three groups will receive single drug and the fourth one will receive all the three drugs. These will be given for four months. Follow up will be done every month. At the end of four months, they will be assessed for any improvement in neuropathy by using Michigan neuropathy instrument and nerve conduction studies. Blood parameters will also be measured again.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPakistan
Collaborators--

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedNov 14, 2023
Enrollment StartJan 9, 2023
Primary CompletionDec 22, 2023
Study CompletionMay 5, 2024
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 2.6 years ago

Interventions

Resveratrol, Alpha lipoic acid, Super oxide dismutasedrug

Tab Resveratrol 1500 mg BD Tab Alpha lipoic Acid 600 mg BD Tab Superoxide dismutase 250 mg BD

Resveratroldrug

Tab Resveratrol 1500 mg BD Tab Placebo 600mg BD Cap Placebo 250mg BD

Alpha lipoic aciddrug

Tab Alpha lipoic acid 600 mg BD Tab Placebo 600mg BD Cap Placebo 250mg BD

Super Oxide Dismutasedrug

Tab Super oxide dismutase 250 mg BD Tab Placebo 600mg BD Cap Placebo 250mg BD