Study on the role and efficacy of Triphala Ghrita Aschyotan in Vataj Abhishyanda w.r.t Allergic Conjunctivitis

Allergic conjunctivitis is a common ophthalmic problem predominantly affecting the outdoor workers. The eyes are exposed to different environmental factors. The eye and eyelids are very common sites for allergic reactions. About 50% of conjunctivitis seen by primary physicians is allergic in nature. Vataj Abhishyanda is a clinical entity which can be correlated with allergic conjunctivitis. Triphala Ghrita Aschyotan helps to relieve the symptoms of Vataj Abhishyand w.r.t allergic conjunctivitis. Triphala Ghrita is a Vyadhi Pratyanik Dravya and helpful in topical eye allergies. Aim: To study the role and efficacy of Triphala Ghrita Aschyotan in Vataj Abhishyanda w.r. t. allergic conjunctivitis. Materials and Method: A total 60 patients of the age group 15-60 years presenting with signs and symptoms of Vataj Abhishyanda w.r.t allergic conjunctivitis were selected randomly from OPD of the department of Shalakyatantra, Government Ayurved College, Nanded (M.S.) within inclusion criteria and were treated in two groups. The 30 patients of trial group were treated with Triphala Ghrita Aschyotana and patients of control group in similar number were subjected to Ketotifen Fumarate eye drop. Results: The trial drug Triphala Ghrita is equally effective as compared to Ketotifen eye drop. Trial drug provided more relief in symptoms like Sangharsha (Itching of eyes), which is the parameter of efficacy. Conclusion:Triphala Ghrita Aschyotan is an effective, safe and potent treatment of Vataj Abhishyanda w.r.t allergic conjunctivitis.


Introduction
Ayurveda, the ancient science of India has described the importance of an eye, without which a life is miserable. A yurveda allocates prime place to sense organs, has recognized that among all sense organs, organ of sight is the greatest gift of God and it is our duty to protect and preserve the eyes. The eye is one of the most delicate organ of the body and any sort of symptom make all of us running to the ophthalmologist. This vital organ is exposed to different environmental factors. The eye and eyelids are very common sites for allergic reactions. About 50% of conjunctivitis seen by primary physicians is allergic in nature.
Sushruta has described the 76 types of eye diseases in his classical text 'Sushruta Samhita'. These eye diseases were classified according to the structures affected in the eye. These diseases are more or less comparable with modern eye diseases. One group of eye diseases known as 'Sarvagata Roga' includes the Netrabhishyanda. Netrabhishyanda is explained under the heading 'Sarvagata Roga' because all the eye disease under this heading are occupying most of the part of the eyeball like Mandala, Sandhi and Patala. Out of all these diseases Netrabhishyanda got tremendous importance because it acts as 'Root Cause' for almost all affections of the eyeball (1). Therefore a wise clinician should treat a case of developing A bhishyanda promptly for the benefit of the patient.
The symptomatology of V ataj Abhishyanda is itching and grittiness of the eyes, foreign body and pricking sensation of eyes, watering, congestion, dryness of eyes, mild lid edema, scanty discharge from eyes, numbness in and around the eye, etc (2). Patients suffering from V ataj A bhishyanda are very commonly found in O.P.D. Hence it has been decided to select V ataj A bhishyanda for the study. V ataj Abhishyanda can be correlated with simple allergic conjunctivitis.
Switching over back to modern, seasonal allergic conjunctivitis and perennial allergic conjunctivitis accounts for 66 to 90% of all cases of allergic eye diseases (3). Ocular allergy beyond being annoying, may get vary disabling and this can lead to serious physical and physiological discomfort, as well as to significant costs in terms of medical care. The management of ocular allergic reaction is primarily aimed at reducing symptomatology and quelling any significant inflammation so this disease was selected to treat with the A yurvedic line of treatment.
Kriyakalpa is the only field of Ayurvedic ophthalmology which has the potential to combat to the suffering humanity and A schyotan is one of the Kriyakalpa mentioned by Acharya Sushruta as a local treatment of eye diseases (4). It relieves the symptoms like itching, pain, hyperaemia, FB sensation, etc. and hence it is useful in all types of Netraroga including  (5). Gayadasacharya stated that Triphala Ghrita is Vyadhipratyanik Dravya (6).Triphala and Ghrita are the Chakshushya Dravya (i.e.beneficial for eyes). These Chakshushya Dravyas by its action nourishes the eyes and gives Bala to the most vital Indriya i.e. Chakshurendriya. Triphala was mentioned repeatedly in different compound preparations by Acharya. So Triphala Ghrita decided for study. Now coming to the modern line of treatment for allergic conjunctivitis which is conservative and symptomatic includes antihistamines, mast cell stabilizers, steroids and NSAIDs. Complete avoidance of allergens exposure may be difficult for many patients. Cold compresses can offer temporary relief. Topical vasoconstrictors with or without antihistamines may provide quick symptoms when the medication is abruptly discontinued. Steroids cause secondary glaucoma and cataract. The artificial tear substitutes and lubricants have short duration of action and develop sensitivity due to toxicity of preservatives in the medicine. The use of preservative free drugs is very costly and many time patients ignore the prescribed treatment. Considering all the lacunas of established treatment and increased prevalent rate of disease due to changing lifestyle it is necessary to look for the alternative therapy which is safe, cheap, easily available and more effective in allergic conjunctivitis. Hence the clinical trial was designed with Triphala Ghrita Aschyotan in Vataj Abhishyanda w.r.t. allergic conjunctivitis

Aim
To study the role and efficacy of Triphala Ghrita Aschyotan in Vataj Abhishyanda w.r. t. allergic conjunctivitis.

Objective
i) To study the effect of Triphala Ghrita A schyotan in comparison with Conventional modern treatment of allergic conjunctivitis w.r.t. V ataj Abhishyanda. ii) To avoid complications of the disease. iii) To prescribe comparatively cheap and easily available preparation in patient's interest.

Materials and Methods
A total 60 patients of the age group 15-60 years presenting with signs and symptoms of V ataj Abhishyanda w.r.t allergic conjunctivitis were selected randomly from OPD of the department of Shalakyatantra, Government Ayurved College, Nanded (M.S) within inclusion criteria and were treated in two groups. The 30 patients of trial group were treated with Triphala Ghrita Aschyotana and patients of control group in similar number were subjected to Ketotifen Fumarate eye drop.

Inclusion criteria
Patients presenting signs and symptoms of V ataj Abhishyanda w.r.t allergic conjunctivitis like itching of eyes, irritation and FB sensation, dryness of eyes, congestion of eyes i.e. redness.
Patients having excessive outdoor work and which are exposed to allergens and the other environmental factors.
Patients of either sex were included in study.

Parameters for assessment
Patients fulfilling the diagnostic criteria were taken for analysis by opting following assessment criteria:  Absolute eosinophil in tear-Present or absent The following symptoms were given score as below:  Sangharsh (i.e. itching of eyes): The graded values were later totally and individually scored and assessed statistically to find out the rate of effect of treatment. The age, sex, occupation, habitat wise distribution of patients with socioeconomic status was also recorded and assessed statistically. The effect of treatment in each group was assessed separately by analyzing the pre treatment and post treatment data, scores and values. The effect of KetotifenFumarate eye drop was assessed and analyzed statistically. The comparison of the effect of therapy of two groups done by applying Chi Square test.

Ingredients of drug for trial group: (7)
1. : Quantity same as Kwatha (640 ml) All the above ingredients are taken into utensils along with stirrer and kept on gas stove or burner. The above mixture is heated till "Snehasiddhi Lakshana" appears in mixture or 320 ml of Ghrita remains in utensil.
Dose: A dose of 2 drops two times a day for 15 day.
Dose: A dose of 2 drops two times a day for 15 day.

Observations
A majority of patients (41.66%) were reported in age group of 15-25 yrs followed by 30% in the age group of 26-35yrs. The observed M: F ratio was 1.60:1. The outdoor workers were 36.67% as consideration with occupation. The habitat wise distribution of patients shows 51.67% cases from urban and 48.33% cases from rural area from both groups. The higher incidence of patients was found in 5-8 months chronicity i.e. 24 cases (40%). Considering recurrence only 10 patients have given follow up for recurrence, out of them 3 patients were found recurrence in experimental group.7 patients from control group have given follow up for recurrence, out of them 3 were found recurrence. It may be exposure to the same allergens.

Results
By statistical analysis, it was proved that, Sangharsha (i.e. itching sensation of eyes), Nistodana (i.e. irritation and foreign body sensation of eyes) and Raag (i.e. Congestion of eyes) were improved in both groups. Paired t-test was significant in both groups (P<0.05). When unpaired t-test was applied for above symptoms, it was highly significant in Sangharsha (i.e. itching sensation of eyes) and Raag (i.e. Congestion of eyes) symptoms which indicates that the trial drug was more effective in both symptoms than control drug and unpaired t-test was insignificant for Nistodana (i.e. irritation and foreign body sensation of eyes) indicates that the trial drug and control drugs are equally effective in FB sensation and irritation of eyes.
In case of V ishuskabhava symptom in all patients cold lacrimation is too much that the Schirmer's test was negative in every patient. Dryness can only be a symptom felt by patient which makes ocular movements difficult. It merely V ishushkabhava means absence of mucoid discharge and not the dryness of eyes.
The limitations of the study are mainly the investigational parameter. The tests regarding the diagnosis of allergic eye diseases are costly like IgE count in tear, skin prick test. Also the eosinophil to come in smear it needs vigorous scraping of conjunctiva. So this thing needs careful as well as skillful efforts. The other tests are performed in big hospitals only. But to diagnose an allergic eye disease these test are used at limited extent and rely more on history. So the eosinophil parameter was not fulfilled in this in this study and it remains a challenge for the future researchers in A yurveda.
In experimental group 13 patients were cured, 10 patients were relieved and 7 patients were not cured. In control group 7 patients were cured, 13 patients relieved and 10 patients were not cured. By applying χ2 test to this it was summarized that both the treatments are effective in V ataj A bhishyanda w.r.t. allergic conjunctivitis. But the experimental group show good efficacy in all 3 symptoms. If we take the large sample the χ2 can be significant at 0.05% level.
The parameter of efficacy was Sangharsha i.e itching sensation of eyes and trial drug shows good results in this symptom than control drug. Also χ2 test to this symptom also comes significant. Hence the trial drug Triphala Ghrita Aschyotan was effective and its role in V ataj A bhishyanda w.r .t. allergic conjunctivits.    In case of all symptoms P<0.05 (t tab =2.05), hence the test is significant. That means the drug therapy Triphala Ghrita Aschyotan is effective in Vataj Abhishyanda w.r.t allergic conjunctivitis.

Table 5: Showing effect of treatment on signs and symptoms of Control Group
In case of all symptoms P<0.05 (t tab =2.05), hence the test is significant. That means the control therapy Ketotifen Fumarate is effective in V ataj A bhishyanda w.r.t Allergic conjunctivitis.
Applying unpaired t-test to compare the results achieved by both treatments are:

e. Foreign Body and pricking sensation of eyes
Here t cal is 0.64 and t tab is 2, i.e. t tab >t cal . Hence t-test is insignificant indicates that there is no significant difference of effect on Foreign Body and pricking sensation (Nistodana) of eyes of both experimental and control group. That means both the drugs are equally acting on this symptoms.

Discussion
The eyes are the most important sensory organ in the body. All out efforts should be made by man to protect the eyes, throughout the period of life. This study was selected to prescribe comparatively cheap and easily available preparation in patient's interest. The A bhishyanda is a disease which we have to treat first in all eye diseases, because it is a prime cause of other eye diseases and leads to various complications.
In V ataj A bhishyanda, V ata is a predominant Dosha and Rasa and Rakta are the Dushyas. The signs and symptoms are purely due to vitiation of V ata Dosha. The various Achakshushya Hetus vitiates Vata Dosha in the Sirasrotas of Urdhwa Jatru region. Then this vitiated Dosha move towards the eye through the eye Sirasrotas confined to the Sira in the eye. If there is Kha-Vaigunya present in the eye i.e. in the Shlaishmik Kala then Syanda is produced which is called as Vataj Netrabhishyanda. Here this Vata vitiation is Swatantra i.e. independent and Kapha and Pitta are the other dependent vitiated Dosha. V ataj A bhishyanda is a disease whose signs and symptoms can be correlated with allergic conjunctivitis.
Triphala is a trio consists of Haritaki, Amalaki and Bibhitaka (8). Sharangdharacharya mentioned that Triphala is a drug of choice for all types of Netrabhishyanda. Acharya Gayadasa quoted in Dalhana commentary that Triphala Ghrita is a Vyadhipratyanik Dravya. Triphala and Ghrita are Chakshushya Dravya i.e. both gives Bala to Chakshurendriya (9). Triphala is believed to have balancing and rejuvenating effect on the three constitutional elements in Ayurveda viz. V ata, Pitta & Kapha. Ghrita has its lubricating action by Snigdha Guna and also as it is Samskaranuvarti (10) it carries the properties of Triphala and act as a good mediator. Also the topical conventional medicaments available in the market are topical decongestants which when used

Groups
Cured Cases Not  Cured  Cases   Total   Experimental 13  10  7  30   Control  8  12  10  30   Total  21  22  17  60 for a long period actually worsen the symptoms, overuse of topical antihistamines causes dryness and topical steroids overuse can cause elevated intra ocular pressure(IOP) , leads to visual damage, increased risk of cataract and clouding of lens that can lead to impairment of vision. These topical drugs costs between 55 to 85Rs/-which are unaffordable to poor patients, while the trial drug costs only 7.5 to 9Rs/-(per 10ml) including preparation cost which is in patients interest and feasible to the researcher also. So it was decided to instill Triphala Ghrita in V ataj A bhishyanda w.r.t allergic conjunctivitis. A charya A rundatta was mentioned in his commentary about the Upashaya of disease V ataj A bhishyanda by Snigdha and Ushna Chikitsa (11). Here Ghrita is a Snigdha Dravya and best V atashamak among the Snehas and by making Triphala Ghrita luke warm we are applying it in conjunctiva so it gives a lubricating and soothing effect in allergic conjunctivitis. Aschyotan Kriyakalpa was selected for the trial because it was a prime treatment in all types of eye diseases (12). A schyotan significantly reduces the congestion of eyes, itching, pricking sensation of eyes, burning sensation, lacrimation, etc. also A schyotan can also be given in Samavastha of the eye diseases so the Kriyalkalpa Aschyotan was decided for the trial.

Probable mode of action (cause and effect relationship)
Acharya Vagbhata stated the mode of action of Aschyotan, as the Aschyotan drug goes in Urdhwajatru i.e. in region above the collar bone, spreads and brings Dosha outside by its Veerya (13).

Samprapti bhanga
The vitiated Dosha are Siranusari and they come in eyes via these Siras (15). Triphala Ghrita when instilled in eyes it breaks the Samprapti of V ataj Abhishyanda, pacify the Vata Dosha and Rakta Dushya. Absorbed more through the Sira, it reaches the circulation and thus acts.

Modern way of action
Siras are routes of pathogenesis in eyes, so drug absorption is more from these Siras in Aschyotan gives results in the symptoms like congestion of eyes. The herbal compounds given in the forms of infusion and decoction contains varying amount of saponins which increases the permeability of epithelium by reducing the surface tension. Also the drug absorption is directly proportional to the vascularity of absorbing surface. Conjunctiva is a vascular tissue containing arcades of blood vessels. So drug absorption is more and result was good. The Triphala Ghrita is a aqueous suspension where the drug is present as small particle kept suspended in an aqueous medium by a dispersing agent (medicated ghee). Particles do not leaves the eye quickly as solutions which increase the tissue contact time. The Triphala Ghrita absorbs through the conjunctival mucosa, percolates into the palpebral conjunctiva and then into the bulbar conjunctiva and acts as a lubricant also. The viscosity of Ghrita, height from which it is dropped on eye ball, frequency and its duration of instillation, size of the drop and condition of the patient and temperature of Ghrita during procedure are all contributory factors to its absorption and action. In this way Triphala Ghrita acts in allergic eye diseases through the conjunctival route of drug administration (16).

Limitations of the study:
The limitations of the study are mainly the investigational parameter. The tests regarding the diagnosis of allergic eye diseases are costly like IgE count in tear, skin prick test. Also the eosinophils to come in smear it need vigorous scraping of conjunctiva. So this thing needs careful as well as skillful efforts. The other tests are performed in big hospitals only. But to diagnose an allergic eye disease these test are used at limited extent and rely more on history. So the eosinophil's parameter was not fulfilled in this study and it remains a challenge for the future researchers in Ayurveda. Another limitation is that the allergic eye disease is a vast topic and it needs a long duration for study perhaps more than three years. So in present study sincere attempt was made to study the disease in least period.

Scope of further study
Since there is an unduly long communication that we have lost the technical aspect of all the Kriyakalpa and it's our duty now to renovate the science and technology. One can study the complex form of allergic eye diseases like Vernal Keratoconjunctivitis, Atopic Keratoconjunctivitis with the help of other forms of medicines like decoction. Allergy is a disease of present era which caused due to suppressed immunity. The modern medicines has lacuna in this area and so an Ayurvedic doctor can treat this disease according to Dosha Dushya and also can prove it on modern parameter basis. Local therapy along with Panchakarma and systemic medicines may be effective. Further study is necessary for the Brimhana of A yurvedic science.

Conclusion
Thus from above study it can be concluded that the trial drug Triphala Ghrita is equally effective as compared to Ketotifen eye drop. However the objective parameter in the above study needs to be further verified by conducting proper investigational methods in allergic conjunctivitis.