1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Clinical Study Report
   Response -  Analytic Code
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [naminavya007@gmail.com].
   


6. For how long will this data be available start date provided 01-11-2023 and end date provided 13-01-2029?
   Response - Beginning 3 months and ending 5 years following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - nil

Introducton

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).

Dry Eye Disease (DED) is a multifactorial disorder of the tears and ocular surface characterized by loss of tear film homeostasis, resulting in ocular discomfort, visual disturbance, and tear film instability, with potential damage to the ocular surface. It is one of the most common ocular surface disorders encountered in clinical practice, with a rising global prevalence ranging from 5% to 50%, particularly affecting the elderly, females, and individuals with prolonged visual display terminal usage. Environmental factors, lifestyle changes, aging, and systemic conditions contribute significantly to its increasing incidence. Due to its chronic nature and impact on quality of life, Dry Eye Disease represents an important public health concern. The last three decades have seen the awareness of dry eye disease rise considerably around the world indicates rising of dry eye patients mainly due to visual display terminal gadget usage and lack of awareness of eye care. Prevalence of dry eye disease is estimated to be 5% to 35% worldwide i.e., 1 out of every 3 to 7 patients could have this condition".The prevalence of Dry eye disease is higher in India than the global prevalence, ranging from 18.4% to 54.3%. It is estimated that 45% of patients older than 40 years may have this problem. 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. Mainly this has a local effect only and, it can’t break the root cause of pathology which often results in recurrence. Also, the main problem is the cost of these medicines. These are prescribed as lifelong therapy and many of the patients will not be in a position to afford these expensive drops.  This has paved way for other medical systems, like Ayurveda, to propose experiments and offer alternative treatments for the Dry eye syndrome.

AIM

To check and compare the efficacy of Shunthyadi Aschyotana (Eye Drop), Mahatriphaladi Ghrita Pana and Anutaila Nasya in the management of Shushkaakshipaka (Dry Eye Disease).

OBJECTIVES OF THE RESEARCH

ü  Primary objectives- To evaluate the efficacy of trial drugs in reducing the irritation or foreign body sensation and burning sensation in the eyes of patients with Dry Eye Disease (Shushkaakshipaka)

ü  Secondary objective -To assess the recurrence of signs and symptoms of Shushkaakshipaka (Dry Eye Disease) during follow up period of 1 month.

METHODOLOGY

Review of Shushkaakshipaka and Dry Eye Disease were done in detail. The selected drugs were prepared in the pharmacy of I.T.R.A., Jamnagar. The selected drug’s pharmacodynamics, pharmacognostical of raw drug and the physiochemical analysis with different parameters of prepared drugs were reviewed. The study came in progress after obtaining ethical clearance by Institutional Ethics Committee with ethics approval no.-PGT/7/-A/Ethics/ 2023-24/760 dated 03/07/2023 and registered in Clinical Trial Registry of India (CTRI) No. CTRI/2023/08/056026 registered on 02/08/2023. Total 107 patients diagnosed to have Shushkaakshipaka with symptoms and signs were registered. The randomization of selected patients was carried out by computerized simple random table method and divided into 2 groups. 52 patients were completed the study. Three patients who left against medical advice were later excluded from the study. Group B received Shunthyadi Aschyotana (Eye Drop) two drops thrice daily and Mahatriphaladi Ghrita Pana, 15ml once daily for 1 month. In group A additionally, Anutaila Nasya (10 Bindu)- administered in two sittings of Nasya for seven days with the interval of seven days (total = 1month).   Follow up assessments occurred 45^th and 60^th day after completion of treatment.

 CONCLUSION

The present study demonstrated that the intervention administered to Trial Group A was more effective than Group B in managing dry eye disease, supporting the alternate hypothesis. Primary outcomes reducing foreign body sensation and burning sensation, showed significantly greater improvement in Group A (p < 0.05), highlighting superior symptomatic relief. Other subjective parameters, including eye strain, dryness of the left eye, photophobia, and conjunctival congestion, also showed significant advantages in Group A, while itching, blurring of vision, and difficulty in open and close eyes were comparable between groups. Objective assessments revealed that Group A achieved greater enhancement in tear film stability (TBUT) and tear secretion (Schirmer-I test), whereas improvements in fluorescein and Rose Bengal staining were similar across both groups. With respect to the secondary objective of assessing recurrence over a one-month follow-up, Group A exhibited a markedly lower recurrence rate across most symptoms. Overall, the findings indicate that the trial intervention in Group A provides clinically and statistically superior efficacy in reducing key symptoms and improving tear dynamics in dry eye disease, validating its therapeutic potential. Based on these findings, the null hypothesis is rejected, and the alternate hypothesis ie. Administration of Shunthyadi Aschyotana (Eye Drop), Mahatriphaladi Ghrita Pana and Anutaila Nasya (Eye Drop) is more effective than Shunthyadi Aschyotana (Eye Drop) and Mahatriphaladi Ghrita Pana in the management of Shushkaakshipaka (Dry Eye Disease) is accepted.