A clinical trial to study the effect of benfotiamine in patients with type 2 diabetes mellitus

Effect of benfotiamine as an adjuvant drug on oxidative stress in patients with type 2 diabetes mellitus Ã¢â?¬â?? a randomized double-blind placebo-controlled clinical trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/07/044161

Enrollment

Registered

2022-07-20

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Benfotiamine: Benfotiamine is a lipid-soluble derivative of thiamine. Benfotiamine 300 mg will be administered in oral formulation once daily for 12 weeks Control Intervention1: Placebo

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age more than 30 years 2. Patients diagnosed with type 2 diabetes mellitus and on treatment with either insulin and/or oral hypoglycemic agents. 3. Subjects who are able to come for follow-up on fixed visits and are well aware of the treatment plan. 4. Subjects willing to participate and able to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who are not willing to participate and will not provide signed informed consent. 2. Patients diagnosed with other medical conditions like HIV which might interfere with parameter levels 3. Patients who consume alcohol regularly 4. Pregnant and lactating women 5. Uncontrolled Hypertensive subjects (BP with or without medication >140/90 mmHg after 5 mins of rest). 6. Subjects with any unstable heart disease or known cases of MI, unstable angina, or CHF. 7. Patients with concurrent Hepatic Dysfunction (defined as AST and/or ALT > 2 times of the upper normal limit) or Renal Dysfunction, uncontrolled Pulmonary Dysfunction (asthmatic and COPD subjects). 8. Patients with ophthalmic conditions 9. Patients with a current or past diagnosis of malignancy (any malignancy diagnosis in the last five years). 10. Patients who had undergone bariatric surgery

Design outcomes

Primary

Measure	Time frame
1. Serum malondialdehyde (MDA) 2. Serum reduced glutathione (GSH) 3. Serum Tumor necrosis factorÃ¢â?¬â??Ã?Â±(TNF- Ã?Â±) 4. Serum Interleukin-6 (IL-6) 5. Serum high sensitive C-Reactive Protein (hs-CRP)Timepoint: At the time of enrolment and at the end of 12 weeks	—

Secondary

Measure	Time frame
NILTimepoint: NIL	—

Countries

India

Contacts

Public ContactDr SHANKAR N S

All India Institute of Medical Sciences

dsarya16@gmail.com011-26594266

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026