Abstract
BACKGROUND:
Prediabetes is an emergent global health problem, reflecting the increasing prevalence of type II diabetes. Reviewing prediabetes is crucial due to its increasing prevalence, economic burden, risk factors association, the potential for real lifestyle modification, the necessity for early intervention and treatment, and its public health impact. Betel leaf chewing is deeply rooted in our tradition through Ayurveda and traditional Chinese medicine systems. Integrating traditional knowledge with current scientific research permits an all-inclusive understanding of the therapeutic potential of betel leaf. Such integration can bridge the gap between traditional practices and evidence-based medicine, providing a holistic attitude to metabolic health.
OBJECTIVES:
The aim of this study is to assess the comparative effectiveness of betel leaf chewing with Tambula granule (TG) on different biochemical parameters such as blood sugar level (BSL), fasting and post-prandial (F, PP), and glycosylated Hb% (HB A1c.) in prediabetes.
MATERIALS AND METHODS:
This prospective, open-label, randomized, comparative clinical trial will be conducted for 60 days. A total of 100 patients will participate in two groups through computer-generated randomization. Outpatients of age 30–60 years, of either sex, having fasting glucose between 100 and 125 mg/dL or postprandial glucose of 140–199 mg/dL will included in this study after written informed consent. Group A (N = 50) will receive betel leaf chewing with Ayurveda ingredients 3.5 g, BD after meal for 60 days. Group B (N = 50) received TG 3.5 g, BD after meal for 60 days. The primary outcome is to assess changes in blood glucose levels before and after the study. Parameters will be assessed at baseline 15th, 30th, 45th, and 60th day. Laboratory parameters (BSL-F, PP, and HBA1C) will be done at screening/baseline and after completion of the study period, that is, 60 days.
DISCUSSION:
Conducting a study on the efficacy of betel leaf chewing in prediabetes is vital to exploring alternative therapeutic options, incorporating traditional knowledge with contemporary medicine, understanding the bioactive compounds and mechanisms of action, assessing safety concerns, and providing evidence-based endorsements. This research can contribute to developing comprehensive and holistic approaches to managing prediabetes and preventing diabetes, improving patient care and outcomes in this field.
TRIAL REGISTRATION:
The trial is prospectively registered with the Clinical Trial Registry of India (CTRI/2021/02/031539, registered on February 25, 2021).