Comparison of the Effectiveness of Centella Asiatica and Placebo on Infection Control and Foot Ulcer Healing in Diabetic Patients

Determiningof the Effectiveness of Centella Asiatica and Placebo on Infection Control and Foot Ulcer Healing in Diabetic Patients

A phase 3 randomized, double-blind, placebo-controlled trial with a parallel group design involving 80 diabetic patients who were referred to the Wound Control Center between January 2025 and April 2025. The randomization will be done through drawing a number.

Location of research: Imam Reza and Best Hospitals in Tehran; Study Population: Hospitalized diabetic patients and those who are referred to the Wound Care Center; Type of Blinding: Double-blind / Method of Blinding: In both study groups, diabetic patients and specialist physicians aren’t aware of each patient’s received treatment

Inclusion criteria: patients with type 1 or type 2 diabetes; aged 18 years and older. Exclusion criteria: patients with poor nutritional status (serum albumin < 3 g/dL), poor diabetic control (HbA1c < 10%), anemia (hemoglobin < 10 g/dL), and a leukocyte count of < 1,000 per cubic millimeter.

Intervention group (Centella asiatica): Diabetic patients will receive Centella asiatica capsules, one daily after meals for 14 days. These capsules have an IRC code in the pharmaceutical industry and an FDA drug manufacturing license. Control group (placebo): Diabetic patients will receive a placebo, just like those in the treatment group. Both groups receive standard diabetic wound treatments, including wound debridement and the application of advanced, specialized dressings.

Wound surface area and depth measurements; wound infection control

In this double-blind clinical trial study, 80 diabetic patients aged over 18 years who were referred to the Wound Control Center of Imam Reza Hospital, affiliated with the Army University of Medical Sciences, were selected and randomly assigned to two control groups: the placebo capsule users and the Centella Asiatica capsule users, with 40 individuals in each group. Each participant in the study is assigned a specific number determined by a drawing a number. Numbers from 1 to 80 are written and placed in a box. Numbers from 1 to 40 are assigned to the treatment group, while numbers from 41 to 80 are assigned to the placebo group. Each participant's number is determined by lottery, ensuring that each individual is randomly placed in one of the groups. The lottery continues until the sample size reaches 80 participants.

The present research is a double-blind study in which neither the diabetic patients (in both study groups) nor the specialist doctor knows who will receive which treatment. In other words, in this research, the researchers who are in contact with the subjects do not know who will receive the real drug, Centella Asiatica capsules, and who will receive the placebo; the participants will also not know to which group they belong. Both the medicinal herb Centella asiatica and the placebo will be provided in capsule form in a pharmacy jar. All capsules will have a similar size, shape, color, weight, smell, and soft texture, and will be dispensed in identical pharmacy jars. The placebo capsules will be administered at the same frequency as the Centella asiatica capsules (one capsule after food, once daily, for 14 days).

In this study, we aim to share information related to the evaluation of wound healing, blood glucose levels, serum levels of inflammatory markers (CRP and ESR), WBC counts, and the control of diabetic foot infections during the treatment process.

The access period will begin once the results have been printed.

Open access will be available to medical researchers, clinical specialists, scientific institutions, universities, and hospitals.

Any statistical analysis and use of documentation that opens up clinical trial data and its impact on research, meta-analysis, and study design improvement is permitted. Therefore, the use of data must align with the creation of knowledge.

Dr. Zahra Jahanbakhsh; AJA university of medical sciences, Etemad zadeh street, Fatemi-Gharbi Street 09124370274 Dr. Mahmoud Momenzadeh Wound Repair Center ,Imam Reza Hospital, Etemad zadeh street, Fatemi-Gharbi Street 09127101386

The usual time from the request of the researcher to access the clinical trial data and documentation will be between 3 and a maximum of 5 working days. The process for researchers who wish to reuse clinical data for research and quality improvement involves submitting a formal administrative request. Additionally, access to the data will be structured to ensure that patient privacy is adequately protected. We hope that by implementing this process, we will reduce the obstacles to clinical research.

Centella asiatica (C. asiatica), due to the presence of compounds such as asiaticoside, asiatic acid, madecassic acid, and other biologically active compounds, exhibits various medicinal activities, including antibacterial, antidepressant, antiemetic, antineoplastic, antioxidant, antithrombotic, anxiolytic, digestive protection, immune modulation, antigenotoxic effects, nerve regeneration, reproductive health, and wound healing. The primary compounds of C. asiatica are triterpene fractions that show a wide range of defensive and therapeutic effects, the most important of which are collagen production and wound healing. Centella asiatica extract is used to improve microcirculation, skin inflammation (eczema, atopic dermatitis, leprosy, varicose ulcers, etc.), fever, intestinal problems, and diseases of the reproductive system. Therefore, in this study, we intend to take a step towards healing diabetic foot ulcers by leveraging the therapeutic effects of Centella asiatica.