A TWO ARM RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED CLINICAL STUDY ON ANTI- CATARACT EFFECT OF SHWETHA PALANDU EYE DROP IN THE MANAGEMENT OF KAPHAJA TIMIRA (IMMATURE CATARACT)

Cataract is an important cause of visual impairment and blindness, affecting 12 to 15 million persons worldwide. The incidence of cataract is distinctly more in developing tropical countries. In India, approximately 3.8 million persons become blind from cataract each year. Owing to the increased rate of incidence of cataract, non availability of effective medical measures and the possible complications and contraindications of surgery, Ayurveda offers an avenue of research for the need of drugs which can effectively manage Current study is open label two arm randomized double blind placebo controlled clinical study on Anti cataract effect of Shwetha Palandu eye drop in the management of Kaphaja Timira in immature cataract.200 Patients with the classical features of Kaphaja Timira (immature cataract) will be selected for the study. A combination of ‘before and after design’ is selected to compare the effect of trail drug and placebo drug before and after treatment in 2 groups. ‘Two eye study design’ to use both the eye for data collection. ‘Worst Eye Study Design’ is taken up for the eye with lowest visual acuity for analysis when both eyes are involved. For Study Group 100 patients with Shwetha Palandu Arka eye drop and for Control Group 100 patients with Jala Arka eye drop (Placebo) will be selected. Dosage will be 3 drops 3 times daily. Duration of treatment will be 60 days.  Periodic follow up of the patients on 15th day, 30th day, 45th day, 60th day, 75th day, 90th day will be done. Subjective parameter are  Blurred vision, glare and floaters. Objective parameter are examination of lens by Slit lamp,Visual Acuity by  LogMAR chart, Contrast Sensitivity test by - PELLI ROBSON CHART,  Refraction by Auto Refractometer readings with Manual correction, Type of  Cataract by Direct Ophthalmoscope, Anterior Segment Photography for cataract with RETRO ILLUMINATION  CAMERA and Assessing cataract opacity by LOCS III GRADING. The participants will be allowed to withdrawfrom the trial if there is any major ailment necessitating the institution ofnew modalities of treatment. Any adverse event, observed during the treatmentperiod or during follow up visits will be clearly documented using ADR form and appropriate and timely management will be done.