Development of Padmakadi eye patch and its clinical comparative evaluation with conventional Bidalaka for anti-inflammatory activity in Anterior segment diseases- An open labelled double arm randomised comparative clinical trial.

Bidalaka is regarded as a trump card among the Ayurvedic Netra Kriyakalpas. It is a savior for all Ayurvedic eye practitioners as it is a good remedy for providing immediate relief in acute inflammatory conditions Bidalaka is a widely accepted and practiced intervention among Ayurvedic practitioners, but sufficient research studies have not been carried out to validate the efficacy of this time-tested treatment modality. Restructuring this intervention into the concept of an eye patch can change the outlook of Ayurveda medications in society. The development of an eye patch is expected to achieve the following benefits: Ensures increased contact time of medication, designed for self-application, ergonomic design, and stability of application.

The trial will have three parts: development of eye patch, insilico study, and clinical trial. The clinical trial will have 2 groups with an allocation ratio of 1:1 and a sample size of  65 people in each group and it will be for 14 days including follow-up. Patients will be recruited from All India Institute of Ayurveda OPD no.110.

Inclusion criterias are:

1.      Acute cases of Conjunctivitis/Epi Scleritis/Subconjunctival hemorrhage / Dry eye with inflammation.

2.      Aged 12 – 60 years (assent will be taken from children of age group 12-18 years.)

3.      Patients without any skin allergies towards exposure to particular materials.

Exclusion criterias are:

1.      Patients with other anterior eye diseases

2.      Patients with dry eye-induced corneal denudation

3.      Patients with raised IOP >21 mm Hg in Non-contact tonometer or Schiotz tonometry.

4.      Patients of dry eye syndrome with corneal staining.

5.      Medically unfit for completion of the trial

6.      Involvement in another interventional research study

The primary outcomes of the study are:

1. Development of Padmakadi eye patch for inflammatory conditions of  anterior segment eye diseases.

2. The anti-inflammatory activity of the Padmakadi eye patch (2 times/day) in terms of reduction in Efron grading of bulbar conjunctival redness, CCLRU grading of Bulbar redness scaleVAS scale for ocular pain and follicular grading of palpebral conjunctiva compared to Padmakadi Bidalaka (3 times/day) in a classical way for 7 days in patients of anterior segment eye diseases.

The secondary outcomes of the study are:

The computational correlation study revealing gene-target interactions among bio-actives in Padmakadi eye patch against anterior segment diseases.

Patients can decide to withdraw from the trial at any time during the course of trial without having to give their reasons of doing so. The follow-up period for the trial will be for 7 days. Continued care will be provided to patients after follow-up period, if found necessary. In case of any adverse events reported during clinical trial they will be reported to the National Pharmacovigilance Coordination Centre (NPvCC), All India Institute of Ayurveda, New Delhi (https://www.ayushsuraksha.com). Ancillary care will be provided to the patients having adverse events related to the trial, if any.