TITLE: Knowledge Attitude and Practice of Diabetic Retinopathy Amongst Diabetic Patients - A Cross-Sectional Survey Study and Evaluation of Efficacy of Shilajatu Rasayana with And Without Kanasaindhavadi Anjana in The Management of Pramehaja Timira–NPDR – An Open Label Two Arm Randomized Comparative Clinical Trial.
RESEARCH QUESTION A. For the cross-sectional survey What is the level of knowledge, attitude and practice regarding diabetic retinopathy among diabetic patients and KAP factors associated with management of diabetic patients? B. For Comparative clinical trial on Shilajatu Rasayana with and without Kanasaindhavadi Anjana in the management of Pramehaja Timira Non-Proliferative Diabetic Retinopathy (NPDR) Is Shilajatu Rasayana is effective in the management of Pramehaja Timira- NPDR and does the addition of Kanasaindhavadi Anjana enhance the treatment efficacy? HYPOTHESIS For the Comparative clinical trial on Shilajatu Rasayana with and without Kanasaindhavadi Anjana in Pramehaja Timira (NPDR). NULL HYPOTHESIS: Shilajatu Rasayana with Kanasaindhavadi Anjana does not provide significantly greater improvement in the management of Pramehaja Timira (NPDR) compared to Shilajatu Rasayana alone ALTERNATE HYPOTHESIS: Shilajatu Rasayana with Kanasaindhavadi Anjana provides significantly greater improvement in the management of Pramehaja Timira (NPDR) compared to Shilajatu Rasayana alone INTRODUCTION IMPORTANCE OF KNOWLEDGE ATTITUDE AND PRACTICE STUDY OF DIABETIC RETINOPATHY Knowledge, attitude and practices (KAP) studies are essential tool in understanding assessing the awareness, perception and behaviors of common people regarding specific health conditions. In the context of diabetic retinopathy KAP Studies helps to identify the gap in knowledge and awareness of the disease and which hamper effective management of disease and lead to complicated disease progression. LACUNAE i. Low awareness and knowledge ii. Inadequate attitudes and practices TRANSLATIONAL VALUES i. Improves patient’s education: Understanding the KAP of diabetic patients regarding diabetic retinopathy enables health care professionals and government to address the knowledge gap and to design targeted educational interventions. ii. Enhanced screening and early detection: by improving the knowledge and attitudes, patients are more likely to participate in regular screening and in early detection of diseases and proper management. SHILAJATU RASAYANA WITH AND WITHOUT KANASAINDHAVADI IN THE MANAGEMENT OF PRAMEHAJA TIMIRA (NPDR) Diabetic retinopathy is the common and potentially blinding complication of diabetes, characterized by progressive damage to retina. Burden of diabetic retinopathy is continuing to rise as the incidence and prevalence of the diabetes increasing worldwide. Early detection and, managements are crucial for preventing visual loss. Shilajatu sevana is mentioned in Prameha chikitsa for reducing the complications. Rasayana chikitsa is potential in managing diabetic complication. Shilajatu Rasayana is explained in Ashtanga Hridaya as Sheeghra Rasayanaphala (has fast rejuvenating power). Kanasaindhavadi Anjana is mentioned in Sannipatika Timira Chikitsa in Astanga Hridaya. LACUNAE Absence of targeted retinal research in ayurveda: Specific research targeting retinal tissues and effect of Shilajatu Rasayana on retinal cells, human trials are missing even though Shilajatu is mentioned in the management of Prameha complications. TRANSLATIONAL VALUES Potential adjunctive effect of Rasayanas in managing Madhumeha complications. Micro vascular support: Role of Shilajatu Rasayana in improving tissue nourishment and microvascular support. Immune modulatory effect of Shilajatu Rasayana in stabilizing retinal health. OBJECTIVES: PRIMARY
FOR KAP STUDY 1.To evaluate the knowledge, attitude and practice (KAP) regarding diabetic retinopathy among diabetic patients.
FOR CLINICAL STUDY 2. To evaluate the changes retinal hemorrhages in patients with Pramehaja Timira (NPDR) with Shilajatu Rasayana alone and Shilajatu Rasayana with Kanasaindhavadi Anjana.
SECONDARY OBJECTIVES: 1.To evaluate the changes in retinal oedema and number and size of hard exudates in terms of OCT and Fundus photography in patients with Pramehaja timira (NPDR) of both trial groups. 2. To evaluate the quality of life in terms of visual acuity in patients of Pramehaja Timira (NPDR) of both trial groups.
METHODOLOGY PART -1: Survey study Aim: to assess the knowledge, attitude and practice regarding diabetic retinopathy among diabetic patients. Study involves survey using structured questionnaires. (previously validated questionnaire KAP - 45) Study settings: AIIA, Diabetic OPD Study design: Cross sectional study Study population: Patients diagnosed with diabetes attending diabetic OPD of AIIA
Assessment Parameters: Qualitative
INCLUSION CRITERIA Patients with diagnosed diabetic mellites. EXCLUSION CRITERIA Nondiabetic patients. Sample size: 400 Methods of data collection: 400 consecutive patients of diabetes attending diabetic OPD of AIIA from 2025-2026 with informed written consent will be recruited for survey. A validated questionnaire on KAP is administered in English as well as local language. The questionnaire will not be shown to the patient. The patient will not be given the answer options or prompted regarding the options. Some questions do not have a right answer and hence, are left unmarked. Correct answers in knowledge and practice sections are highlighted in green. In the Attitude section, the responses best indicative of positive attitude are highlighted in green. Some questions in knowledge and practice sections may have more than one correct answer. Each correct response is given a score of one. PART -2: CLINICAL STUDY TYPE OF STUDY DESIGN: An open label, two arm, randomized, comparative clinical trial. Sample size: 36 eyes in each group Group A: Receiving Shilajatu Rasayana alone Group B: Receiving Shilajatu Rasayana with Kanasaindhavadi Anjana STUDY SETTINGS: Intervention groups (A & B): Department of Shalakya tantra of AIIA, Sarita vihar, New Delhi.
Patients attending Eye OPD of department of Shalakya tantra, AIIA, New Delhi with signs and symptoms of NPDR will be taken irrespective of sex, religion, occupation, education etc. They will be screened based on inclusion and exclusion criteria. STUDY POPULATION Patients diagnosed with non-proliferative diabetic retinopathy (NPDR) and under standard of care for diabetes. Eligibility criteria for participants INCLUSION CRITERIA Patients suffering from type II DM having mild to moderate NPDR. Patients willing for ayurvedic treatment. Patients between 30 - 70 years Taking any of Anti-hyperglycemic agents. EXCLUSION CRITERIA History of glaucoma Severe NPDR with macular thickness above 300microns Patients with moderate or severe cataract changes Hypertensive retinopathy changes. Patients with PDR and other complications. Patients with complications like diabetic nephropathy. Patients having systemic diseases like uncontrolled hypertension HbA1c is more than 10 after OHA/ insulin Greater than 200mg/dl FBS after OHA/ insulin Patients with Cardiovascular complaints DIAGNOSTIC CRTITERIA Signs and symptoms Diminished vision Floaters Flashes of light Dark adaptation ICD 11 NPDR Grouping Trial group Group A: Patients receiving standard of care for the management of diabetes will be given Shilajatu Rasayana Shilajatu Rasayana prepared with Triphala Kashaya (as mentioned in classics) – 6 gm Triphalabhavita Rasayana twice daily for 49 days Group B: Patients receiving standard of care for the management of diabetes will be given Shilajatu Rasayana 6gm Triphalabhavita Rasayana twice daily and Kanasaindhavadi Anjana for 49 days. Total duration of the Trial: 79 days (49 days Shilajatu Rasayana sevana + Kanasaindhavadi Anjana + follow up after 30th day)
Group Intervention Days Dose Time Administration Group A Shilajatu Rasayana 49 6 gm Twice daily Oral (After Food)
Group B Shilajatu Rasayana 49 6gm Twice daily Oral (After Food) Kanasaindhavadi Anjana 49 60 mg Twice daily Anjana (Topical)
Sno. Drug Scientific/ Botanical Name Quantity
1. Shilajatu Rasayana Shilajatu (Black bitumen) 6gm
Haritaki (Terminalia chebula Retz.) Vibhitaki (Terminalia bellerica Roxb.) Amalaki (Phyllanthus emblica)
Sno. Drug Scientific/ Botanical Name Quantity
1.Kanasaindhavadi Anjana yoga Usira (Veteveria zizanoids) 60mg (As Anjana) in each eye Kana (Piper longum Linn.) Saindhavam (rock salt) Ghrita (Cow’s ghee) Madhu (Honey)
Group A – 36 eyes Group B – 36 eyes RANDOMIZATION Block randomization with variable block size. SEQUENCE GENERATION Computer generated sequence. MASKING Open label two arm trial. ASSESSMENT PARAMETERS SUBJECTIVE ASSESSMENT CRITERIA (ASSESSMENT WILL BE DONE ON THE BASIS OF GRADING PATTERN WHICH WILL BE VALIDATED PRIOR TO ITS IMPLEMENTATION) Diminished vision (Snellen’s chart) Floaters Flashes of light Dark adaptation OBJECTIVE ASSESSMENT S. No PARAMETERS INSTRUMENT BEFORE TREATMENT ON 0TH DAY ON 21st TH DAY AFTER TREATMENT ON 49th DAY AFTER FOLLOW-UP ON 79th DAY 1. Visual acuity testing ETDRS LogMAR SCALE + + + + 2. Fundus photo (seven field) ZIESS VISUCAM 500 + + + + 3. Macular Thickness ZEISS CIRRUS HD - Optical Coherence Tomography (OCT) + + + + 4. C peptide + - + 5. CBC with ESR - + - + 6. FBS - + - + 7. PPBS - + - + 8. HbA1C - + - + 9. Lipid profile - + - +
OUTCOMES PRIMARY FOR KAP STUDY 1.The changes in the knowledge, attitude and practice (KAP) regarding diabetic retinopathy among diabetic patients. FOR CLINICAL STUDY 2. The changes in retinal hemorrhages in patients of Pramehaja Timira (NPDR) with Shilajatu Rasayana alone and Shilajatu Rasayana with Kanasaindhavadi Anjana. SECONDARY 1.The changes in retinal oedema and number and size of hard exudates in terms of OCT and Fundus photography in patients with Pramehaja timira (NPDR) of both trial groups. 2. The change in the quality of life in terms of visual acuity in patients with Pramehaja Timira (NPDR) of both trial groups.
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