Efficacy of Akshitarpana and Pana of Mahatriphaladi Ghrita in the Management of Timira (Simple Myopia) - An Open Labelled Randomized Comparative Clinical Trial

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Introduction
Eye is the most specialized sense organ serving the most vital function providing sight to living creature Good. Vision is crucial for social and intellectual development. Acharya Sushruta has clearly mentioned that prevention of eye diseases should be the utmost aim rather than its curative aspect 5 and if neglected or improperly treated, these diseases may ultimately lead to the total loss of vision 6 .
Acharya Sushruta discoursed on the chapter seven -Drishtigata Roga Vijnaniya which deals with the Rupa, Samprapti, Pathya-Apathya, Chikitsa of the diseases which are peculiar to the Drishti of the eye. Among them the present study deals with the details of the disease named as Timira affecting the Patala 7 . Timira is considered as a disease affecting the Drishti which left untreated causes Drishtinasha.When Apathya Ahara-Vihara has been continued for a long period, it leads to Khavaigunya and vitiated Dosha takes place in the Prathama Patala can complain of "Avyakta Darshana" which can be correlated with complain of difficulty in seeing far object or all the external objects appears dim and hazy to the sight. When it occurs in the Dwitiya Patala, there are complaints of "Vihwala Darshana" can be correlated with confused visual perception and seeing false image of Makshika (fly), Mashakana (insect), Keshana (hair), Jalani (web), Mandalani (circles), Pataka (flag), Mariachi (mirage), Pariplavacha can be correlated with seeing unexciting objects and floaters. Acharya Vagbhatta added other complaints are "Bhutam Tu Yatnata Aasnna" and "Dure Sukshuma Cha Na Ikshate" in the Dwitiya Patala can be correlated with difficulty for near and distance vision 8 . According to the dominancy of Dosha among all the vitiated Doshas when reach to the Prathama and Dwitiya Patala; it causes Vataja-Pittaja-Kaphaja-Raktaja-Sannipataja Timira accordingly. Rupa of Doshika Timira occurs according to vitiated Dosha in Sansthan 9 .
According to clinical features of Prathama and Dwitiya Patalagata Timira, in Modern science can be corelated with clinical findings simple myopia. Also called physiological myopia. It is dioptric condition of the eye in which with the accommodation at the rest incident parallel rays come to a focus anterior to the light sensitive layer of retina. Among the four varieties classified clinically, simple myopia is the commonest variety. Various surveys in India have found myopia prevalence ranging from 6.9% to 19.7% 11 . Simple Myopia has been implicated as the 6th leading cause of vision impairment. In Asia, prevalence of simple myopia is higher ranging 40% in general population and 80% in students. As regards to prognosis low or International Journal for Multidisciplinary Research (IJFMR) E-ISSN: 2582-2160, Volume: 4, Issue: 4, July-August 2022 moderate degree of simple myopia are not likely to progress. Only widely used corrective lenses are just providing an aid to diminished vision. Surgical measures are carried out if required other than the glasses or contact lenses which has its own risks and complications apart from being expensive.
• Aim: To assess the efficacy of Akshitarpana and Pana of Mahatriphaladi Ghrita in the management of Timira (Simple Myopia). • Objective: To assess the efficacy of Mahatriphaladi Ghrita Pana and Akshitarpana in the management of Timira (Simple Myopia).

Materials and Methods
Institutional Ethics Committee (IEC) approval was taken prior to initiation of research. No any adverse drug reaction has been recorded during the course of the trial. Study was registered in Clinical Trial Registry of India CTRI/2020/11/029217. Patient information sheet was prepared and the patient informed consent was taken before starting the treatment.
Total 40 patients of Timira (Simple Myopia) were registered from outpatient department and inpatient department of Shalakya Tantra, IPGT&RA, Jamnagar. They were randomly allocated into two groups adopting computerised randomisation technique as follows: The patients were given treatment for a period of 30 days. After completion of the treatment, the patients were followed up for 1 month at the interval of 15 days.
Raw herbal drug of Mahatriphaladi Ghrita was procured from Pharmacy, Gujarat Ayurved University, Jamnagar and authenticated in Pharmacognosy laboratory, IPGT and RA, Gujarat Ayurved University, Jamnagar. Then the medicines were prepared adopting the standard API methods Ghrita.

Criteria of Selection Inclusion Criteria
 Patient within the age group of 10-25 years with normal fundus were included in the study.  Patients having signs and symptoms of Timira (Simple Myopia) described as per Ayurveda and Modern science.  Myopia up to -6D were included in the study.

Exclusion Criteria
 Patient below age of 10 years and above 25 years.  Patient having any other known ocular pathology.  Patient having myopia more than -6D.  Patient having myopic degenerative changes.

Investigations
Haematological examinations (Hb%, TC, DLC, ESR), Urine analysis (Physical, Chemical and Microscopic) and Biochemical-RBS has been carried out before treatment to rule out any systemic disease. Lipid profile analysis (S. Cholesterol, S. Triglycerides, S. HDL, S. LDL, S. VLDL) has been carried out before treatment to rule out any systemic disease and after treatment to note any changes in these parameters.

Criteria for Assessment
Assessment was done on the basis of scoring pattern applied for subjective and objective parameters both before and after treatment.

Subjective Criteria
Symptoms of Simple myopia i.e.

Objective Criteria
Routine Examination and investigations: • Visual Acuity with Snellen's Chart • Direct and Indirect Ophthalmoscopy The details of the score adopted for the main signs and symptoms in this study are as follows:

Statistical Analysis
The data obtained in clinical study were subjected to statistical analysis by evaluating the significance of the interventions using paired and unpaired t tests. After obtaining the P value, it was observed as insignificant P > 0.05, significant P < 0.05, highly significant was P < 0.01.

Observation
Among all the participants in this clinical trial 80% had complaints of Durastha Avyakta Darshana (Indistinct distant vision) and 47.5% had complaints of Vihwala Darshana (Blurred vision), 50% had complaints of Shiroabhitapa (Headache) and 47.5% had complains of Netrasrava (Eye discharge).

Results
In the present study total 40 patients were registered, 20 in group A and 20 in Group B, and all of them completed the course of study. The effect of therapy in 40 patients of OSMF is presented below.

Effect of Therapies on Chief Complaints Subjective Parameters Chief Complaints
In Group A, mean score of Durastha Avyakta Darshana was reduced from 1.58 to 0.47 with percentage of relief 70.31% which was statistically highly significant (p < 0.001). While, mean score of Vihwala Darshana was reduced from 1.083 to 0.250 with percentage of relief 70.31% which was statistically highly significant (p < 0.001).
In Group B, mean score of Durastha Avyakta Darshana was reduced from 1.60 to 1.13 with percentage of relief 32% which was statistically significant (p < 0.001). While, mean score of Vihwala Darshana was reduced from 1.70 to 1.33 with percentage of relief 33.33% which was statistically significant (p < 0.001).

Associated Complaints
In Group A, mean score of Shiroabhitapa was reduced from 1.08 to 0.18 with percentage of relief 83.31% which was statistically highly significant (p < 0.001). While, mean score of Netrasrava was reduced from 1.00 to 0.00 with percentage of relief 90% which was statistically highly significant (p < 0.001).
In Group B, mean score of Shiroabhitapa was reduced from 1.0 to 0.63 with percentage of relief 36.36% which was statistically significant (p < 0.05). While, mean score of Netrasrava was reduced from 1.0 to 0.30 with percentage of relief 58.33% which was highly statistically significant (p < 0.001).

Objective Parameters Visual Acuity
In Group A, mean score of Right Eye Visual Acuity was reduced from 4.30 to 3.45 with percentage of relief 19.76% which was statistically highly significant (p < 0.001). While, mean score of Left Eye Visual Acuity was reduced from 4.450 to 3.45 with percentage of relief 22.47% which was statistically highly significant (p < 0.001).
In Group B, mean score of Right Eye Visual Acuity was reduced from 4.90 to 4.45 with percentage of relief 8.33% which was statistically highly significant (p < 0.001). While, mean score of Left Eye Visual Acuity was reduced from 4.90 to 4.45 with percentage of relief 9.18% which was statistically highly significant (p < 0.001).

Refraction
In Group A, mean score of dioptric power of spherical lens in Right eye was reduced from 1.71 to 1.40 with percentage of relief 17.36% which was statistically highly significant (p < 0.001). While, mean score of dioptric power of spherical lens in Left Eye was reduced from 1.66 to 1.37 with percentage of relief 16.52% which was statistically highly significant (p < 0.001).
In Group B, A, mean score of dioptric power of spherical lens in Right eye was reduced from 1.76 to 1.55 with percentage of relief 12.05% which was statistically significant (p < 0.005). While, mean score of dioptric power of spherical lens in Left Eye was reduced from 2.06 to 1.76 with percentage of relief 12.05% which was statistically significant (p < 0.05).

Axial Length
In Group A, Axial length of right eye mean score reduced from 23.420 to 23.395 with percentage relief 0.116% and in left eye mean score reduced from 23.482 to 23.470 with percentage relief 0.059% were found. Both eye Axial length results were statistically insignificant in Group A.
In Group B, Axial length of right eye mean score reduced from 23.561 to 23.59 with percentage relief 0.004% and in left eye mean score reduced from 23.572 to 23.57 with percentage relief 0.002% were found. Both eye Axial length results were statistically insignificant in Group B.    In Group A, dioptric power of spherical lens was reduced better percentage in Right and Left Eye Visual Refraction i.e., 17.36% in right eye and 16.52% in left eye in comparison to Group B i.e., 12.056% in both right and left eye. The comparative data is statistically significant (p < 0.05) in all these parameters. In Group A, 75% of patient's patient got complete remission, 20% of patients got moderate improvement, 5% patients remained unchanged. While no patients got marked improvement.
In Group B, 20% of patient's patient got complete remission,10% of patients got marked improvement, 25% of patients got moderate improvement, 20% of patients got mild improvement and 25% patients remained unchanged.
No any adverse effect found in the present study till the follow-up period.

Probable Mode of Action of Mahatriphaladi Ghrita Akshitarpana
Akshitarpana (ocular therapy) is one of the local therapeutic procedures aimed to give nourishment to the eye through Medicated Ghrita, Ghritmanda, Vasa, Majja etc. which made stagnant in the eye for a specular time period in a particular formed frame which if promptly used reveal an objective piece of evidence of excellent responses are already been mentioned by Acharyas.
Akshitarpana acts as a prophylactic and curative therapy for maintaining the natural acuity and condition of eyes. It has Brimhana quality. It cherishes the eyes, improves and invigorates the Drishti Shakti. It is preventive and remedial procedure in Vataja and Pittaja Vikara.
The drugs used in Akshitarpana procedure is the combination of Ghrita and medicines, hence the drug can easily cross the corneal epithelium (being lipophilic) and endothelium (being hydrophilic). Also due to more contact time the active component of drug used in Akshitarpana will be absorbed more and may leads to cure the diseases by providing proper nourishment to the structures.
In Ayurveda, Mahatriphaladi Ghrita described as Rasayana having Sheeta Virya and Balya, Brimhana property to protect body from various diseases. The Ghrita has trespassing into minutest channels of the body and enters into deeper layer of Dhatus through Rupavaha Siras and purifies every minutest part of channels while pacifying Pitta dosha. So, it is highly effective in Drishtigata Roga having dominancy of Alochaka Pitta. as that of Mahatriphaladi Ghrita Akshitarpana alone in the management of Timira (Simple Myopia). The duration of the treatment is short; so, further long-duration studies are needed. It is recommended that the study should be carried out on a large number of patients with longer duration to evaluate and analyse the efficacy of drugs.

Financial Support and Sponsorship
IPGT and RA, Gujarat Ayurved University, Jamnagar, Gujarat, India.

Conflicts of Interest
There is no conflict of interest.
Consort flowchart of this study is described in Figure 1. Website : www.ijfmr.com Email : editor@ijfmr.com