1. What data in particular will be shared?
   Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   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 - Any purpose.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [gautam.dabhi@cvmu.edu.in].
   


6. For how long will this data be available start date provided 01-12-2024 and end date provided 31-07-2026?
   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

Introduction:

Acharya Sushruta describes six patala in Netra in which 2 Bahya vartma patala and 4 patala in netra - tejo Jalashrita, Pishitashrita, medoashrita, and last Ashtiashrita, dosha enters in 1st and 2nd patala it’s called Timir.

Dalhana described, Tejo-jalashrita patala Teja means alochaka pitta situated in siragata rakta, jala means twachagata rasa dhatu.

According to Acharya Sushruta Timir causing dosha when reach internal orbital organs through the sira and occupies pratahama patala causing blurring of vision, pratahama patalagata timira vitiates the superficial dhatu.

Acharya Sushruta has mentioned Vedhana karma one of the Ashtvidha shastra karma. Here the meaning of Viddha or Vedhana – is to pierce or penetrate something.

Acharya Vagbhat Describe Anjana types, form, matra, kal and according to dosha use of Anjana karma in sutra sthana chapter 23.

For all types of Timir Acharya Vagbhat describe Akshabeejadi Anjana in Uttartantra.

According to a study by NCBI, the prevalence of myopia in India varies between 3.6% and 36.5% depending on the type of study. Population-based studies have a prevalence rate of 3.6% to 36.5%, while school-based studies have a rate of 7.5% to 8.6%, and hospital-based studies have a rate of 9%. Most of these studies include people under the age of 40.

Myopia, commonly referred to as short-sightedness, is the most common eye disease in the world with a substantial social, educational, and economic impact on the affected one.

Simple myopia can be corrected with spectacles or contact lenses, whereas pathological myopia is often associated with potentially blinding conditions such as retinal detachment or macular degeneration.

Origin of the Research Problem:

 In modern science, the best option for myopia is wearing glasses or contact lens for myopia.

Another option is LASIK surgery but light sensitivity develops after LASIK surgery complications like Dry eye.

So, we can search for alternative medicine Vedhana karma comparison with Akshabeejadi Anjana and add on effect of Vedhana Karma.

 Key Questions:

 1. Only Vedhana karma is Effective in Prathama Patalagata Timir (Myopia <-6D)

2. Only Akshabeejadi Anjana is effective in Prathama Patalagata Timir (Myopia <-6D) 

3. Add-on effect of Vedhana karma with Akshabeejadi Anjana more effective in Prathama Patalagata Timir (Myopia <-6D)

Hypothesis:

Null hypothesis (H0)

Vedhana karma and Akshabeejadi Anjana have no significant effect in Prathama Patalagata Timir (Myopia <-6D)

 Alternative hypothesis (Ha)

 Vedhana karma and Akshabeejadi Anjana having significant effect in Prathama Patalagata Timir (Myopia <-6D)

Objectives:

Primary

1.         To study the etiopathology of Prathama Patalagata Timir in Ayurveda and Modern.

2.         To evaluate the effect of Vedhana Karma in Prathama Patalagata Timir (Myopia -<6D)

Secondary

1.         To evaluate the effect of Akshabeejadi Anjana in Prathama Patalagata Timir (Myopia -<6D)

2.         To evaluate the effect of Vedhana Karma with Akshabeejadi Anjana in Prathama Patalagata Timir (Myopia -<6D).

 Research Gap/Review of Literature (International Status/National Status and scope of the proposal):

The treatment of myopia (comparable to Prathama Patalagata Timira) has undesirable aspects such as the permanent use of spectacles.

Akshabeejadi Anjana is one of the effective treatments of Timir.

Vedhana karma, despite being simple and easy to do, remains unexplored in this condition.

Methodology:

Study design - Open Labelled Randomized Comparative Clinical Study.

Group A Vedhana karma

Group B Akshabeejadi Anjana

Group C Vedhana karma & Akshabeejadi Anjana

Sample size total – 138 (Each group 46 Patients Group A 46, Group B 46 and Group C 46)

Inclusive criteria

Patients with myopia < -6D in at least one eye, diagnosed as per ICD-10-CM Diagnosis Code H52.1 & H52.2 (Simple myopic astigmatism)

Age 18-30 years

Both Gender

Exclusive criteria

 Myopia >-6D

Patient having diseases of Corneal, Choroid, Vitreous, retinal and ciliary muscle

Contraindicated for Vedhana Karma and Anjana

Systemic diseases like DM, Hypertension, Trauma, etc.

Patient is on medication for a blood thinner