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Comparative Study of Combination Treatment of Bionerv E+ Versus Vitamin B Complex in Treatment of Diabetic Polyneuropathy in Type 2 Diabetic Patients and Its Effect on Wound Healing
Sponsor: BREGO Life Sciences
Summary
Diabetic symmetrical polyneuropathy (DSPN) is a common complication of diabetes that affects the nerves, especially in the legs and feet. It can cause pain, numbness, tingling, weakness, and loss of sensation. These problems can affect daily activities and quality of life. Loss of sensation can also increase the risk of foot wounds and problems with wound healing. This study is comparing two treatments in people with type 2 diabetes and DSPN. The main purpose is to find out whether a combination of alpha-lipoic acid, vitamins B1, B6, B12, and vitamin E is providing greater improvement in neuropathy symptoms than vitamins B1, B6, and B12 alone. The study is also examining changes in wound healing. About 100 participants are taking part at Hospital Canselor Tuanku Muhriz (HCTM). Participants are being randomly assigned to one of two treatment groups. One group is receiving Bionerv E+, which contains alpha-lipoic acid, vitamins B1, B6, B12, and vitamin E. The other group is receiving a vitamin B-complex containing vitamins B1, B6, and B12. Both treatments are being taken daily for 12 weeks in addition to standard treatment for DSPN. Researchers are assessing participants before and after treatment. These assessments are examining nerve problems in the lower limbs, pain, quality of life, and blood markers related to inflammation. For participants with diabetic foot ulcers, researchers are also assessing changes in the wounds.
Official title: Comparative Study of Combination Treatment of Vitamin B Complex, Alpha Lipoic Acid and Vitamin E Versus Vitamin B Complex in Treatment of Diabetic Polyneuropathy in Type 2 Diabetic Patients and Its Effect on Wound Healing
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2025-07-22
Completion Date
2027-01-30
Last Updated
2026-10-16
Healthy Volunteers
No
Interventions
Alpha-Lipoic Acid, Vitamin B1, Vitamin B6, Vitamin B12, Vitamin E
Oral dietary supplement containing alpha-lipoic acid 300 mg, vitamin B1 39 mg, vitamin B6 8 mg, vitamin B12 500 mcg, and vitamin E 100 IU per tablet. Participants are taking two tablets once daily after a meal for 12 consecutive weeks, in addition to standard treatment for diabetic symmetrical polyneuropathy.
Vitamin B1, Vitamin B6, Vitamin B12
Oral dietary supplement containing vitamin B1 100 mg, vitamin B6 200 mg, and vitamin B12 200 mcg per tablet. Participants are taking three tablets once daily after a meal for 12 consecutive weeks, in addition to standard treatment for diabetic symmetrical polyneuropathy.
Locations (1)
Hospital Canselor Tuanku Muhriz (HCTM) UKM
Cheras, Kuala Lumpur, Malaysia