Researchers at the Institute of Herbal Medicine (IHM) of the National Institutes of Health (NIH), University of the Philippines Manila, have announced the development of an ampalaya (bitter melon) tablet for the management of type 2 diabetes. The tablet, derived from Momordica charantia, is positioned as a scientifically validated herbal medicine, offering a natural alternative for managing blood sugar levels.
Professor Daisy-Mae A. Bagaoisan, a registered pharmacist and research assistant professor at IHM, highlighted the growing global concern of diabetes, particularly non-insulin dependent diabetes mellitus (nIDDM), especially in low and middle-income countries like the Philippines. The ampalaya tablet aims to complement existing treatments for managing this condition.
Clinical Efficacy and Safety
The ampalaya tablet utilizes powdered ampalaya leaves, known for their potential in lowering blood sugar levels. Clinical trials, spanning phases 1 to 3, demonstrated that the tablet significantly reduces fasting plasma glucose by the third week of treatment and decreases glycosylated hemoglobin after 12 weeks. These results are reportedly comparable to those achieved with glibenclamide, a common drug used to manage type 2 diabetes.
"Our studies have shown that the ampalaya tablet can produce a significant reduction in blood sugar levels, comparable to the drug glibenclamide," Prof. Bagaoisan stated. "The tablet has undergone rigorous clinical trials (phases 1 to 3) and has been found to effectively reduce fasting plasma glucose by the third week of treatment and decrease glycosylated hemoglobin after 12 weeks."
Herbal Medicine vs. Herbal Supplement
A key distinction of this ampalaya tablet is its classification as a herbal medicine, not merely a supplement. Herbal medicines undergo rigorous testing for safety and efficacy and are regulated by health authorities like the Philippine FDA. This contrasts with herbal supplements, which are often marketed without therapeutic claims. The ampalaya tablet has undergone extensive clinical trials, proving its therapeutic effect on blood sugar levels.
Formulation and Stability
The ampalaya tablet is formulated according to WHO guidelines and remains stable at room temperature for at least one and a half years. Prof. Bagaoisan emphasized its safety profile, noting that it is a viable option for those seeking an herbal remedy with no known side effects.
Collaborative Development
The development of the ampalaya tablet involved a multidisciplinary team of experts, including pharmacognosists, agricultural specialists, pre-clinical researchers, pharmaceutical scientists, and clinicians. This collaborative effort facilitated the tablet's registration as an herbal medicine with the Philippine FDA. The technology transfer document was completed in 2006, paving the way for wider public availability.
