Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO

In ophthalmology, Dry Eye Syndrome is a common issue, corresponds to the traditional Ayurvedic concept of “Sushkakshipaka”. This condition is characterized by inadequate tear production, resulting in a lack of proper lubrication and nourishment for the eyes.Tears play a vital role in maintaining the cornea’s health and ensuring clear vision. Dry eye is a chronic concern, especially among the elderly, and is influenced by various factors such as ageing, medical conditions, medicine side effects, dry climates and increased screen time.In the previous studies carried out in various countries estimate the prevalence of dry eye disease to be between 5-34 %, while India is at 29.25%. Despite the vital significance of maintaining vision and the prevalence of Dry Eye Syndrome, effective treatment solution remains limited. Traditional Ayurvedic texts provide comprehensive guidance on the management of Sushkakshipaka. Arka kalpana are mentioned for the management of eye diseases. It has more shelf life, increased potency, and it is laghupaki, vyavayi and vikasi. Daruharidra arka used in this study has the properties like chakshushya, netraruja-hara, sodhahara, kanduhara, ropana. According to Susruta samhita considered Shushkakshipaka is due to due to excessive vitiation of vata. And Ashtanga Hridaya has attributed involvement of vata and pitta doshas in the pathogenesis In a recent study on dry eye management, Daruharidradi seka shows promising results in relieving ruksha, toda, raga, and daha. The ushna virya of Daruharidra helps to pacify the Vata dosha making way for samprapti vighatana and relieving symptoms. Based on this, here we are using Daruharidra arka in the management of dry eye. Carboxymethylcellulose eye drops is taken as the control group in this study. The clinical study will be carried out in 40 patients (20 patients in two groups by lot or chit method) with signs and symptoms of Dry Eye Syndrome who fulfil inclusion criteria belonging to either sex from OPD and IPD of Amrita School of Ayurveda Clinical assessment is done using subjective parameter Ocular Surface Disease Index (OSDI) Questionnaire. And Objective Parameters is done using Tear film break up time,Schirmer test 1 Consent will be taken in their own language before treatment. Subjective and objective parameters will be assessed and recorded in CRF. To group A Aschyotana is done with Daruharidra arka (3 drops) two times a day for a duration of one month. For group B Aschyotana is done with Carboxymethylcellulose eye drops (3 drops) two times a day for a duration of one month. After treatment both subjective and objective parameters will be assessed and recorded. Follow on 15th day after the treatment to assess the sustained effect of the treatment. The data obtained will be tabulated and statistically analysed using Wilcoxon signed rank test and Paired-t-test