An open label randomized controlled clinical study on the evaluation of efficacy of Shatahvadi Ghrita Tarpana in Non-Proliferative Diabetic Retinopathy, Pramehajanya Timira

The present clinical trial entitled as “AN OPEN LABEL RANDOMIZED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF SHATAHVADI GHRITA TARPANA IN NON PROLIFERATIVE DIABETIC RETINOPATHY (PRAMEHAJANYA TIMIRA)” is conducted to address Diabetic Retinopathy which is a leading cause of vision loss in working age adults. It can be silent in the beginning and progress to irreversible vision loss. It is characterized by diminished vision, floaters in vision, flashes of light in vision and delayed dark adaptation. Diabetic Retinopathy can be classified as Non Proliferative and Proliferative Stages. Non proliferative stage is the initial stage of the disease which is caused due to hyperglycemia induced microvascular occlusion and increased retinal vascular permeability. The present study was done on the non-proliferative stage.

The dissertation includes two parts. The first part of the dissertation deals with Introduction about Diabetic Retinopathy and its understating through Ayurveda and its Chikitsa. Review of Literature comprising of Netra Shareera, Anatomy of Eye and Retina in detail, Etymology, Classification, Etiopathology, Clinical features, and Treatment of different types of Diabetic Retinopathy. Etymology, Nidana of Prameha and Timira, Etiopathogenesis of Pramehajanya Timira and its Chikitsa. It also includes brief review on Netra Tarpana, Drugs used in Shatahvadi Ghrita and Durvadi Ghrita.

The second part includes Materials and Methods which comprises method of preparation of drugs, sample source, diagnostic criteria, inclusion and exclusion criteria, study design, assessment criteria, Observations and Results, Discussion and Conclusion.

The trial was registered prospectively in CTRI on 18-07-2023 with CTRI Number CTRI/2024/08/072301

   An Open labeled, Randomized, Controlled Clinical Study was carried out. 40 subjects were selected from OPD, IPD of JSSAMC&H, Mysuru and other Medical Camps and were divided into two groups (Group A and Group B) based on computerized randomization, each comprising 20 subjects.

Both the Groups were administered Mridu Rechana with Gandharvahasthadi Eranda Taila on Day 0. Group A subjects received Netra Tarpana with Shatahvadi Ghrita and Group B subjects received Netra Tarpana with Durvadi Ghrita from Day 1 to Day 7 Assessment was done on Day 0 (before treatment), Day 8 (after treatment), Day 15 (1st  follow up), Day 30 (2nd follow up) and Day 30 (3rd follow up).

The assessment was done based on Subjective Parameters such as Diminished vision, Floaters in vision, Flashes of Light in Vision and Delayed Dark Adaptation. Objective Parameters such as Visual Acuity for Distant Vision with Snellens Chart and Visual Acuity for Near vision with Snellens Near vision Chart was assessed in all assessment periods. Fundus Photography was taken to evaluate retinal features such as microaneurysms, intra retinal haemorrhages, hard exudates, cotton wool spots and venous beading on Day 0 (before treatment) and Day 30 (2nd Followup).

Statistical analysis for the above parameters was done using Wilcoxon signed-rank test, Mann-Whitney U test.  Based on observations and results, it was concluded that Shatahvadi Ghrita Netra Tarpana is effective in the management of Non proliferative Diabetic Retinopathy.

Both Shatahvadi Ghrita Netra Tarpana and Durvadi Ghrita Netra Tarpana has similar effect on Non Proliferative Diabetic Retinopathy (Pramehajanya Timira)