Knowledge Attitude and Practice (KAP) 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.

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.