Type 2 diabetes mellitus (T2DM) remains a major global health problem due to its high prevalence, long-term complications, and substantial economic burden. Conventional antidiabetic therapies, including insulin and oral hypoglycemic agents, may cause significant side effects during long-term use and are contraindicated in certain clinical conditions. Therefore, safe and effective herbal-based alternatives are needed.
Previous preclinical and early clinical studies have shown that bitter melon (Momordica charantia L.) and snakehead fish (Channa striata) possess antidiabetic and anti-inflammatory properties, including improvement in glucose regulation, stimulation of insulin secretion, and regeneration of pancreatic cells. However, clinical evidence on their combined use remains limited.
This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the effect of daily supplementation with a combination of bitter melon extract and snakehead fish powder on glycemic status in adults with Type 2 diabetes mellitus. Ninety eligible participants will be randomly assigned to a treatment group receiving 500 mg/day of the herbal combination or a placebo for 4 weeks. Glycemic status will be assessed primarily through glycated albumin (GA) levels.
The findings of this study are expected to provide scientific evidence regarding the safety and efficacy of this herbal combination as a complementary antidiabetic therapy.
Diagnosed with Type 2 Diabetes Mellitus (DMT2).
Fasting plasma glucose ≥ 126 mg/dL and ≤ 200 mg/dL or random blood glucose between 200-300 mg/dL.
Age 20-65 years
Duration of diabetes 0-15 years.
Pregnant or breastfeeding; or having impaired kidney or liver function (serum creatinine > 1.5 mg/dL; SGOT/SGPT > 2× upper limit).
Allergy to snakehead fish powder (Channa striata) or bitter melon extract (Momordica charantia).
Using antidiabetic medications other than metformin, or unable/unwilling to comply with study procedures.