Status of evidence on efficacy and safety of Indian Traditional medicine (AYUSH) for Pre-diabetes and Type-II Diabetes Mellitus: Protocol for Qualitative Review & Evidence Map synthesis (Preprint)
Authors: R Galib , Ahmad Azeem , S. Gundeti Manohar , R Meena , Wilson Eugene , Itrat Malik , Javed Ghazala , Quamri Mohd Aleemuddin , Singh Chalia Deepti , Yadav Pooja , T P Athul , K P Karthik , C S Anjana , H S Mythri , Dileep Aparna , Shetty P Shifa 
Published: February 2025

BACKGROUND

Introduction: Non-communicable diseases, particularly Diabetes, are a growing global burden, with India rapidly becoming the diabetes capital of the world. Data on diabetes Awareness, treatment, and control from 20,78,315 Indians in NFHS-5 in 2023 revealed that of those with the disease, 27.5% (27.1–27.9%) were aware, 21.5% (21.1–21.7%) were receiving treatment, and only 7% (6.8–7.1%) had their diabetes under control.
Over 81% of people with diabetes hail from low-and middle-income countries. With their emphasis on lifestyle management and holistic approach, traditional medical systems present a promising alternative that may help lessen the burden of diabetes through sustainable and natural methods. Traditional medicine uses many therapeutic concepts to manage diabetes, but there is no appropriate methodology to demonstrate their effectiveness.

OBJECTIVE

The aim of this study is to develop a protocol that qualitatively evaluates the status of evidence on safety and efficacy of Indian Traditional systems of Medicine (AYUSH) for the management of Pre-diabetes and Type- II Diabetes Mellitus to establish a road map of evidence through research for better outcomes in future.

METHODS

All study designs including Systematic reviews and meta-analysis, Narrative reviews, RCTs, non-randomized CTs , parallel arm intervention trials, Pre-test post-test trials, observational studies (including cross-sectional , case- control and cohort studies), case series and case reports from the first available published literature to July 2024 will be assessed. All the AYUSH interventions studied in India as Standalone or Add-on to Standard of Care for the management of Diabetes will be included in the study. The database search will be performed with all AYUSH key words related to Prediabetes and Type II Diabetes mellitus using Boolean operators. The safety and efficacy of AYUSH interventions will be evaluated based on specified Subjective and objective measures including Clinical recovery, Quality of Life, any adverse events that are specific or otherwise based on LFT, KFT, and Lipid profile etc.

RESULTS

protocol is developed.

CONCLUSIONS

Large translational gaps remain despite increased awareness of the global diabetes crisis and ongoing multinational efforts to curb rising diabetes rates which makes way for the contribution of Traditional system of medicine. Though there are differences in treatment types available in India's traditional medicine systems, a protocol has been developed to effectively map the evidence for all treatments available for Type II diabetes and prediabetes in AYUSH systems of medicine.

CLINICALTRIAL

PROSPERO (International Prospective Register for Systematic Reviews) Reg. No. – CRD42024545045