Clinical Study of Jasakadi Rasayan in the management of non-proliferative diabetic retinopathy with Optical Coherence Tomography (OCT) biomarkers as visual outcome predictors

TITLE- CLINICAL STUDY OF JASAKADI RASAYAN IN THE MANAGEMENT OF NON-PROLIFERATIVE DIABETIC RETINOPATHY WITH OPTICAL COHERENCE TOMOGRAPHY (OCT) BIOMARKERS  AS VISUAL OUTCOME PREDICTORS 

PRIMARY RESEARCH QUESTION-- Is Jasakadi Rasayan effective in the management of non-proliferative diabetic retinopathy, with improvement in key OCT biomarkers as visual outcome predictors?

SECONDARY RESEARCH QUESTION- Is Jasakadi Rasayan effective in lowering the HbA1c levels when administered as an adjunct therapy to standard care?

 

Study Design Type - Prospective, single-arm clinical trial

INCLUSION CRITERIA-

   

1  Patients with type 2 Diabetes,

with or without visual disturbances, but with detectable ophthalmoscopic features of mild to moderate Non-proliferative Diabetic Retinopathy (such as exudates, hemorrhage, microaneurysm, cotton wool spots)

2   Patients of either sex between 40 to 70 years old

EXCLUSION CRITERIA-

1  The patients with type 1 Diabetes or type 2 Diabetes taking insulin

2  Patients with recent cataract surgery within the previous 3 months

3  Hazy media for fundus evaluation

4  History of proliferative diabetic retinopathy (PDR) or other advanced eye diseases (retinal detachment, uveitis, Glaucoma, etc.).

5  Active uncontrolled systemic diseases

6  Pregnant or breastfeeding women

7  Participants in another clinical trial within the past 3 months

Sample size- Total 80 eyes

Trial Drug -- Jasakadi Rasayan Tablet ( It has Shuddha Jasad Bhasma, Shuddha Suvarna Makshik Bhasma, Triphala, Haridra, and Daruharidra)

Dose- Jasakadi Rasayan tablet 250 mg twice a day for 90 days

ROUTE OF ADMINISTRATION- Orally

Duration of treatment- 3 months (90 days)

FOLLOW-UPS-  After 1 month and after 3 months

Variables to be studied from Digital Fundus Photography-- Microaneurysm, Cotton Wool Spots, Hard Exudates, and Retinal Hemorrhage

OCT Biomarkers to be studied --

1  Macular oedema (EDTRS Grid)

2  Disorganization of inner retinal layers (DRIL)

3  Hyper reflective Foci (HRF)

4  Intraretinal cystoid spaces(ICS)

5  Sub-foveal neuro-retinal detachment(SND)

6  Vitreomacular traction(VMT)

Results--

The result will be drawn based on the criteria of assessment and Statistical analysis.