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PROTOCOL
Year : 2021  |  Volume : 5  |  Issue : 2  |  Page : 95-98

Safety and efficacy of Ayurveda interventions in diabetic retinopathy: Protocol for systematic review


1 Regional Ayurveda Research Institute, Thiruvananthapuram, Kerala, India
2 Central Council for Research in Ayurvedic Sciences (CCRAS), New Delhi, India
3 National Center for Indian Medical Heritage, Hyderabad, Telangana, India
4 National Ayurveda Research Institute for Panchakarma, Cheruthuruthy, Kerala, India

Correspondence Address:
Dr. Praveen Balakrishnan
Regional Ayurveda Research Institute, Poojappura, Thiruvananthapuram 695012, Kerala.
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jras.jras_28_21

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Introduction: Diabetic retinopathy (DR), a complication of diabetes mellitus, is a leading cause of blindness on a global level. Nonproliferative diabetic retinopathy (NPDR) and proliferative diabetic retinopathy (PDR), both with and without diabetic macular edema (DME), are the stages of DR. The conventional treatment strategies for DR include intravitreal injections, laser photocoagulation, and surgical approach. There are quite a few individual studies available in various databases showing the efficacy of Ayurveda intervention in DR. However, a systematic review of these studies is not available to date. The aim of this study is to perform a systematic review of various clinical studies of Ayurveda treatments in DR, along with meta-analysis, if possible. This shall help in providing more precise estimates of the effectiveness of management of DR using Ayurveda interventions. Methods and Analysis: A systematic review of randomized controlled trials (RCTs), quasi-randomized controlled trials (QRCTs), controlled clinical trials (CCTs), multiple arms clinical trials, and single-group studies on DR published/unpublished from January 1990 to November 2020 will be conducted. The database search will be performed using the words with Boolean operators: Ayurveda OR Ayurvedic AND Diabetic Retinopathy as title, abstract, or keyword. Clinical trials of patients fulfilling the diagnostic criteria based on signs and symptoms of DR in any of its stages, irrespective of age and either gender, will be selected. Studies that are based on the Ayurvedic treatments such as Shodhana (purification therapies), Shamana (pacification therapies), Netra Kriyakalpa (topical ophthalmic application of medications), Moordha Taila Prayoga (topical application of medicine on head), Mukha Kriya Kramas (usage of medicine on/in mouth and on face such as Mukhalepa, Kabala, Gandoosha) irrespective of dosage, type, schedule, drug, form, and advised Pathayapathya (lifestyle changes) as intervention or control will be selected. Response to treatment, both subjective and objective, is the primary outcome and onset of serious adverse events is the secondary outcome. Ethics and Dissemination: Ethical approval was obtained from the Institutional Ethics Committee. The results obtained will be published in a peer-reviewed journal. Trial Registration Number: International Prospective Register for Systematic Reviews (PROSPERO) number CRD42019136750.


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