Introduction of a clinical guideline to manage type-2 diabetes by ayurvedic practitioners in India: intervention development and feasibility study Diabetes (type-2) is a complex disorder with major health, social and economic consequences. India has the world's second largest diabetes population. Diabetes is one of the top diseases for which patients consult ayurvedic (traditional medical system) practitioners. A high proportion of diabetes patients use ayurvedic treatments, often from the beginning and exclusively and throughout their lives. These are particularly popular among rural, poor, older and tribal populations. The Indian government, therefore, deploys ayurvedic practitioners in Primary Health Centres (PHCs), often as the main clinical provider. 
Despite the effectiveness and safety of several ayurvedic medicines for managing diabetes found in study settings, strong concerns remain about the sub-optimal diabetes management of many patients in ayurvedic clinical practice. The actions to be taken at different stages of the diabetes care pathway are largely left to the judgement of the individual ayurvedic practitioner, resulting in unacceptable variations in ayurvedic clinical practice. Many non-evidence based ayurvedic medicines are prescribed by ayurvedic practitioners, which can have serious adverse effects on patients. A potential solution could be the introduction of a clinical guideline that will make recommendations based on the best available evidence.
The main aim is to establish whether the introduction of a clinical guideline can improve the management of diabetes by ayurvedic practitioners as compared to usual ayurvedic management (i.e., without any clinical guideline). This will be tested in a future main study. Before this, we will develop the clinical guideline and will check with our participants if the main study can be conducted. The study will be conducted in Kerala, India - a vast population in Kerala is living with diabetes, and the utilisation of ayurveda is high. 
We will follow the standard clinical guideline development process. Recognising that the scientific evidence base is not large for many ayurvedic components (e.g., lifestyle), we will draw similar evidence from the standard western medicine clinical guidelines. A systematic review will be conducted on the effectiveness and safety of ayurvedic medicines in diabetes management, to generate evidence statements. These statements will be presented to an independent clinical guideline development committee (involving a range of stakeholders) for making the final decisions. Based on these decisions, the clinical guideline will be drafted and pre-tested among 20-30 ayurvedic practitioners. The clinical guideline will be shared with them, followed by qualitative interviews to improve it. 
Subsequently, a study will be conducted to check if the main study can be done. 12 rural PHCs with an ayurvedic practitioner will be randomly allocated either to the clinical guideline-based diabetes management group or the comparator group. At least 120 new diabetes patients, diagnosed by the participating ayurvedic practitioner, will be recruited. Quantitative data (numerical) will be collected and analysed on the study-specific issues, such as quantities that are needed to estimate study size of the main study, recruitment of PHCs and patients, follow-up of patients, and ayurvedic practitioners' adherence to the clinical guideline. Qualitative interviews will take place with all the 12 ayurvedic practitioners and 20-30 patients to explore how they have found taking part in the study and any particular issues experienced. Those who decline to participate in the study will be interviewed to explore the reasons behind.  
If the feasibility of undertaking the main study is promising, the main study will be conducted. If found to be effective, diabetes patients will benefit from improved health outcomes, such as better blood glucose control and lower diabetes complications. The related future clinical, personal and economic burden on patients and their carers and families will be reduced. The Global Challenges Research Fund (GCRF) supports cutting-edge research to address challenges faced by developing countries. The fund addresses the UN sustainable development goals. It aims to maximise the impact of research and innovation to improve lives and opportunity in the developing world.