Efficacy of Shunthyadi Aschyotana (Eye drop), Mahatriphaladi Ghrita Pana and Anutaila Nasya in the management of Shushkaakshipaka (Dry eye disease)-An Open labelled Randomized clinical trial

Dry eye has been defined by the International Dry Eye Workshop as a “A multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film, and accompanied by ocular symptoms, in which tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles’’. It is also called as keratoconjunctivitis sicca (KCS), keratitis sicca, sicca syndrome, xerophthalmia, dry eye syndrome (DES), ocular surface disease (OSD), dysfunctional tear syndrome (DTS) or simply dry eyes. Numerous diagnostic procedures, such as questionnaires, tear film tests, epithelial abnormalities, and others, were listed by DEWS II in the diagnosis report. It includes Positive symptomatology (Dry Eye Questionnaire-5 >5 or OSDI >13), plus non-invasive BUT < 10 seconds or Osmolarity > 308 mOsm/L or interocular difference >8 mOsm/L, or Ocular surface staining (>5 corneal spots, >9 conjunctival spots, or lid margin).In Ayurveda, On the basis of signs and symptoms it can be correlated with Shushkaakshipaka. Shushkaakshipaka classified as Sarvagata Netraroga among all the 76 Netrarogas by Acharya Susruta and mentioned it as Vata predominant Vyadhi characterized by Kunita Vartma (Narrowing of palpebral aperture), Daruna Ruksha Vartma (Hardness and dryness at lid margin and cilia), Aviladarshana (Blurring of vision), Sudarunam Yat Pratibodhane (Difficulty to open the eyes/ Photophobia). According to Acharya Vagbhata it is a Vata-Pitta predominant Vyadhi and has additional features such as Gharsha (foreign body sensation), Toda (pricking pain), Bheda (Tearing pain), Upadeha (Discharge/stickiness of lids), Rukshatwa, Darunatwa of Vartma and Akshi (hardness and roughness of the eyelids and eye), Sheetecha (desire for cold), Shula (Pain) and Paka (Inflammation). The mainstay of management of Dry Eye Disease in contemporary medicine is by instillation of artificial tear supplements, preservation of natural tears & excess mucous may be treated by acetyl cystine & in severe cases some ocular surgeries. The tear lubricants mentioned are a failure in reproducing the tears because the natural tears are a complex mixture of lipids, mucin and water.In the present study Anutaila Nasya(Eye Drop) along with Mahatriphaladi Ghrita Pana and Shunthyadi Aschyotanahas the potential to provide more significant results

GROUP A: No. of patients: Minimum50 patients

Drug (A): Shunthyadi Aschyotana (Eye Drop)

·      Dose          : 2 drops, thrice in a day (4 hourly)

Total– 0.75 ml per day (In both eyes)

·      Duration   : 30 Days

·      Form         : Eye Drop

Drug (B): MahatriphaladiGhrita Pana

·      Dose          : 15 ml O.D. (Empty stomach in the Morning)

·      Duration    : 30 Days

·      Form         : Ghrita

·      Anupana*: KoshnaJala*

Drug (C): AnuTaila Nasya

·      Dose**:** 10Bindu (~5ml) in each nostril

·      Time**:** Aparahnna (Evening) One time

·      Duration**:** Two sittingsof Nasya for Seven days with theinterval of seven days (total = 1month)

·      Form**:** Taila

GROUP B: No. of patients: Minimum50 patients.

Drug (A): ShunthyadiAschyotana (Eye Drop)

·      Dose          : 2 drops 3times per day (4 hourly)

Total– 0.75 ml per day (In both eyes)

·      Duration   : 30 Days

·      Form         : Eye Drop

 Drug (B): Mahatriphaladi Ghrita Pana

·      Dose          : 15 ml O.D. (Empty stomach in the Morning)

·      Duration   : 30 Days

·      Form         : Ghrita

·      Anupana*: KoshnaJala*