Clinical Safety of Selected Ayurvedic Formulations in Common Eye Diseases

RESEARCH ARTICLE 10.5005/jp-journals-10064-0022 Clinical Safety of Selected Ayurvedic Formulations in Common Eye Diseases 1 Shruti Khanduri, 2 Sarada Ota, 3 Alok Srivastava, 4 Mridula Dua, 5 Deepa Makhija, 6 Pradeep Dua, 7 Babita Yadav 8 Vanmala B Wakode, 9 Rakesh Rana, 10 Richa Singhal, 11 Narayanam Srikanth ABSTRACT Introduction: Allergic conjunctivitis (AC), dry eye syndrome (DES), and computer vision syndrome (CVS) are few of the eye diseases that commonly affect the working class. Allergic conjunctivitis is often associated with Kaphaja abhishyanda. Dry eye syndrome is caused due to chronic lack of sufficient lubrication and moisture on the surface of the eye. The CVS is a visual complaint that is clinically similar to DES. In Ayurveda, the symptoms of DES can be included under the spectrum of two different diseases, Krichronmeela and suskakshipaka. Tarpana, Aschyotana, Nasya, and oral use of Ayurvedic medicines are commonly advocated for eye diseases. Objective: Critical analysis and presentation of clinical safety and efficacy outcomes of classical Ayurvedic formulations, viz., Mahatriphaladya ghrita, Triphala kwatha, and Anu taila, in patients of common eye diseases. Materials and methods: Data were collected from three different clinical studies, viz., AC, DES, and CVS, that have been completed in peripheral institutes of Central Council for Research in Ayurvedic Sciences (CCRAS) and were critically evaluated to assay the safety profile of three drugs. Clinical safety assessments were done through analyzing liver function tests (LFTs) and kidney function tests (KFTs) before and after the trial period. Paired sample t-test was used to compare the mean changes from baseline to the end of the trial period. The study revealed that all the parameters were within the specified limits during the entire period. Conclusion: The findings in the three different clinical studies clearly reveal that Mahatriphaladya ghrita, Triphala kwath, and Anu taila are clinically safe, effective, and tolerable in common eye diseases. Keywords: Allergic conjunctivitis, Anu taila, Computer vision syndrome, Dry eye syndrome, Mahatriphaladya ghrita, Triphala kwath. 1-8 Research Officer (Ayurveda), 9 Statistical Officer (Statistical) 10 Statistical Assistant (Statistical), 11 Deputy Director General (Ayurveda) 1,2,6-11 Central Council for Research in Ayurvedic Sciences, New Delhi, India 3 Regional Ayurveda Research Institute for Eye Diseases Lucknow, Uttar Pradesh, India 4,5 Central Ayurveda Research Institute for Cardiovascular Diseases, New Delhi, India Corresponding Author: Shruti Khanduri, Research Officer (Ayurveda), Central Council for Research in Ayurvedic Sciences, New Delhi, India, Phone: +919213121355, e-mail: drshruticcras@gmail.com How to cite this article: Khanduri S, Ota S, Srivastava A, Dua M, Makhija D, Dua P, Yadav B, Wakode VB, Rana R, Singhal R, Srikanth N. Clinical Safety of Selected Ayurvedic Formulations in Common Eye Diseases. J Res Ayurvedic Sci 2017;1(4):223-230. Source of support: Nil Conflict of interest: None INTRODUCTION Eye is the most important sense organ in our body, and any disease that affects the functioning of eye should be diagnosed and treated with great caution. Allergic conjunctivitis, DES, and CVS are few of the eye diseases that commonly affect the working class. Ocular allergy represents one of the most common ocular conditions encountered in clinical practice. 1 The AC is an inclusive term that encompasses many allergic conditions, which cause the symptom of conjunctivitis. Irrespective of the type of cause, symptomatology consists of itching, redness, increased lacrimation, and swelling of the conjunctiva. 1 Kaphaja abhishyanda, a variety of abhishyanda mentioned in Ayurveda classics, is etiologically and clinically similar to AC. Symptoms, such as itching and chemosis are the predominant symptoms of kaphaja abhishyanda and redness of eyes is produced by the involvement of rakta. The DES is a common disorder, characterized by instability of the tear film that can be due to insufficient amount of tear production or due to poor quality of tear film, which results in increased evaporation of the tears. 2 The main symptom of dry eyes is a dry and gritty feeling in the eyes. The additional symptoms include burning or itching in the eyes, foreign body sensation, excess tearing, pain, redness of the eyes, and photophobia in some cases. 3 Around the world, it has been estimated that nearly 60 million people experience vision problems as a result of computer use, which has become a part and parcel of today s life. 4 Both visual and ophthalmic symptoms occur among computer users. These have collectively been called the CVS. However, the major contributor to CVS symptoms by far appears to be dry eye. 5 It is estimated that daily usage of the computer for more than 2 hours may result in a 90% chance to develop CVS. 6 The CVS is clinically similar to DES as they both share the Journal of Research in Ayurvedic Sciences, October-December 2017;1(4):223-230 223

Shruti Khanduri et al symptoms of dryness of eye. Visual complaints include blurred vision, burning, stinging, and photophobia. 4 In Ayurveda, the symptoms of DES can be associated with two different diseases, Krichronmeela (mentioned by Vagbhata) and sushkakshipaka (mentioned by Susrutha). The initial stages may begin with symptoms of krichronmeela and later when there are structural changes, it can be compared with suskakshipaka. 7,8 The current treatment of common eye diseases as per modern modality is limited. Frequent dosing of up to 4 times per day and topical antihistamines may be irritating to the eye, especially with prolonged use. 9 In order to limit the potential side effects and find out safe and effective drugs that give a long-lasting effect, exploration of Ayurvedic medicines is the need of the hour. There is vivid description of many Ayurvedic formulations and procedures in Ayurveda classics, which are beneficial in the treatment of common eye diseases. Ayurvedic treatment, in addition to administration of Ayurvedic medicine orally, includes Tarpana, Aschyotana, and Nasya for eye diseases. Mahatriphaladya ghrita, Triphala kwath, and Anu taila are few among the multitudes of formulations that are presently in use and this set of studies was done to analyze the safety of Mahatriphaladya ghrita, Triphala kwath, and Anu taila in patients with AC, DES, and CVS. Drug Profile In Ayurveda texts, Mahatriphaladya ghrita is exclusively mentioned in the context of Netraroga (eye disorder). This formulation is mentioned in Bhaisajya Ratnavali and its important therapeutic uses are Naktandhya (night blindness), Timira (early stage of cataract), Kaca (cataract), Nilika (mole), Patala Arbuda (growth in layers of eye), Netrabhisyanda (conjunctivitis), Adhimantha (glaucoma) Pakshmakopa (trichiasis/entropion), Netraroga (eye disorder), Adrishti (loss of eyesight), Mandadristhi (diminished vision), Netrasrava (chronicdacrocystitis/epiphora), Netrakandu (itching in eyes), Duradrishti (hypermetropia/ hyperopia), and Samipadrishti (myopia). Triphala kwath is also mentioned in Bhaisajya Ratnavali and its important therapeutic uses are for Netraroga (eye disorder) and for Dhavana (cleansing). Triphala has been used for internal and external purposes since time immemorial, and is mentioned as Chakshushya rasayana (medicine that adds vitality and promotes the health of eyes) by Ayurveda. Anu taila is mentioned in Astangahrdaya, sutrasthan and its important therapeutic uses are urdhvajatrugata Roga (disorders of body parts above clavicle), Tvakrauksya (dryness of skin), Palita (graying of hair), Skandha suskata (emaciation of shoulder), Grivasuskata (wasting in cervical region), and Vakshasuskata (emaciation of chest muscles) (Table 1). 224 Table 1: Components of Mahatriphaladya ghrita, Triphala kwath, and Anu taila Mahatriphaladya ghrita 10 Sanskrit name Botanical/English name Part used Triphala Rasa Terminalia bellerica Pericarp kwatha Terminalia chebula Pericarp Emblica officinalis Pericarp Bhrngaraj Ras Eclipta alba Plant (whole) Vasa Rasa Adhatoda vasica Leaf Satavari Rasa Asparagus racemosus Root tuber Ajakshir Goat milk Guduchi Ras Tinospora cordifolia Stem Amalaki Rasa Emblica officinalis Pericarp Kana Piper longum Fruit Sita Sugar candy Draksha Vitis vinifera Dry fruit Haritaki Terminalia chebula Pericarp Bibhitaka Terminalia bellerica Pericarp Amalaki Emblica officinalis Pericarp Nilotpala Nymphaea stellata Flower Madhuka Glycyrrhiza glabra Root Ksira Kakoli Fritillaria roylei Subterranean root Madhuparni Tinospora cordifolia Stem Nidigdhika Solanum xanthocarpum Plant (whole) Ghrita Clarified butter from cow s milk Triphala kwath 11 Amalaki Emblica officinalis Pericarp Bibhitaka Terminalia bellerica Pericarp Haritaki Terminalia chebula Pericarp Anu taila 12 Jivanti Leptadenia reticulata Root Jala Coleus vettiveroides Root Devadaru Cedrus deodara Heart wood Musta Cyperus rotundus Rhizome Tvak Cinnamomum zeylanicum Stem bark Usir Vetiveria zizanioides Root Sweta sariva Hemidesmus indicus Root Sweta candana Santalum album Heart wood Daruharidra Berberis aristata Stem Madhuk Glycyrrhiza glabra Root Plava Cyperus scariosus Rhizome Agaru Aquilaria agallocha Heart wood Satavari Asparagus recemosus Root tuber Pundrahva Nelumbo nucifera Flower Bilva Aegle marmelos Root/stem bark Utpala Nymphaea stellata Flower Dhavanidvaya Brhati Solanum indicum Plant (whole) Kantakari Solanum surratense Plant (whole) Surabhi Alpinia officinarum Root/leaf Sthiradvaya Salaparni Desmodium gangeticum Plant (whole) Prsniparni Uraria picta Plant (whole) Krimihara Embelia ribes Flower Patra Cinnamomum tamala Leaf Suksmaila Elettaria cardamomum Seed Renuka Vitex negundo Seed Kamal Nelumbo nucifera Androecium Jal Potable water Taila Sesamum indicum Seed oil Ajadugdha Goat milk

OBJECTIVE Critical analysis and presentation of clinical safety and efficacy outcomes of classical Ayurvedic formulations, viz., Mahatriphaladya ghrita, Triphala kwatha, and Anu taila, in patients with common eye diseases, generated through multicenter (AC and DES)/unicenter (CVS) open labeled studies at different CCRAS centers. MATERIALS AND METHODS The formulations fulfilling the physicochemical standards and quality parameters, and prepared as per standard operating procedures, were used for all the studies. These three different clinical studies were approved by the Institutional Ethics Committee of all the participating centers and done in accordance with World Health Organization Good Clinical Practice Guidelines. The study medications included Mahatriphaladya ghrita (15 ml twice daily given with lukewarm water for a period of 12 weeks) in the AC and DES for 84 days. Mahatriphaladhya ghrita was also used in CVS in the dose of 5 ml twice daily for 42 days. Triphala kwath was used for aschyotana in AC (10 drops twice a day for 12 weeks) and Mahatriphaladya ghrita topically for Tarpana in DES and CVS (20 ml once a day for 5 consecutive days in the morning and repeated at an interval of 4 weeks in DES, 3 days in the morning and repeated at 15 days in CVS). Anu tail nasya, 8 drops in each nostril was administered for 7 days in CVS. Followup was done finally after 2 weeks without medication and to record the onset of any adverse reaction during the intervention in all the three studies. Open labeled multicenter clinical trials were done in selected peripheral institutes of CCRAS to evaluate the safety and efficacy of Mahatriphaladya ghrita, Triphala kwath, and Anu taila in common eye diseases. All the three studies were registered in the Clinical Trial Registry of India. The details are briefed in Table 2. The data obtained from the completed clinical studies were analyzed prospectively to assess the safety profile of Mahatriphaladya ghrita through LFTs and KFTs. Statistical Analysis Laboratory parameters at the beginning and at the end of the trial period were compared using paired t-test. A p-value of <0.05 was considered significant. All statistical analysis was performed using Statistical Package for the Social Sciences version 15.0. OBSERVATION Study I: Effect of Mahatriphaladya ghrita and Triphala kwath in AC Oral administration of Mahatriphaladya ghrita and Triphala kwath Aschyotana for 84 days revealed significant Clinical Safety of Selected Ayurvedic Formulations Journal of Research in Ayurvedic Sciences, October-December 2017;1(4):223-230 225 Table 2: Brief description of studies conducted in the management of AC, DES, and CVS Study interventions Dosage schedule Intervention period Sample size No. of centers Current names Name of study Study period Study design 12 weeks 12 weeks For oral 15 ml BD with lukewarm water. For Aschyotana 10 drops BD 54 Mahatriphaladya ghrita Triphala kwath 2 1. Central Ayurveda Research Institute for Cardiovascular Diseases, New Delhi 2011 2012 Open label interventional single arm prospective multicenter study Clinical evaluation of Mahatriphaladya ghrita in the management of AC (CTRI/2012/07/002777) 2. Ayurveda Regional Research Institute, Patna 12 weeks Tarpana is to be done for 5 consecutive days in the morning and repeated at an interval of 4 weeks For oral 15 ml BD with lukewarm water. Topical Tarpana 20 ml once OD 59 Mahatriphaladya ghrita 2 1. Central Ayurveda Research Institute for Cardiovascular Diseases, New Delhi 2. Ayurveda Regional Research Institute, Patna 2011 2012 Open label interventional single arm prospective multicenter study Clinical evaluation of Mahatriphaladya ghrita in the management of DES (Shushkakshipaka) (CTRI/2012/03/002532) 42 days Tarpanfor 3 days, i.e., 8th, 9th, and 10th day and at the interval of 15 days, i.e., 26th, 27th, 28th day 7 days For oral 5 ml BD with lukewarm water. For Topical Tarpana 20 ml OD For Nasya Anu tail 8 drops in each nostril 62 Mahatriphaladya ghrita 1 Central Ayurveda Research Institute for Cardiovascular Diseases, New Delhi 36 months Open label interventional single arm prospective unicenter study Clinical evaluation of efficacy of Mahatriphaladya ghrita and anu taila nasyam in the management of CVS (CTRI/2015/02/008438)

Shruti Khanduri et al improvement in the common complaints, such as lacrimation (<0.001), photophobia (<0.001), burning sensation (<0.001), foreign body sensation (<0.001), redness (<0.001), and anxiety (<0.001) of the patients suffering from AC. Among the total 54 patients who completed the trial, the majority were males and 44.4% of patients were belonging to Vata-Pittaja Prakriti. About 92.6% were literate and 9.3% hailed from lower socioeconomic stratum. About 22.2% were vegetarians. The therapy also provided statistically significant changes in qualitative parameters, such as lacrimation, photophobia, burning sensation, foreign body sensation, redness, anxiety, etc. Serum lipid profile (serum cholesterol, serum triglycerides, and low-density lipoprotein), serum bilirubin, serum glutamate pyruvate transaminase (SGPT), serum glutamic oxaloacetic transaminase (SGOT), serum alkaline phosphatase, total protein, serum albumin, serum globulin, blood urea, and serum creatinine were within normal limits during the entire period, and the values were compared with paired t-test before and after the trial. There was no detectable change in these parameters. No significant adverse drug reactions or adverse events were observed during the study (Tables 3 and 4, Graphs 1 to 4). 226 Table 3: Demographic profile of the patients in AC, DES, and CV Demographic profile AC (n = 54) DES (n = 59) CVS (n = 62) Sex Male 32 (59.3%) 28 (47.5%) 44 (70.9%) Female 22 (40.7%) 31 (52.5%) 18 (29.1%) Education Not able to read 4 (7.4%) 8 (13.6%) and write Literate 50 (92.6%) 51 (86.4%) 62 (100%) Socioeconomic status Below poverty line 5 (9.3%) 18 (30.5%) 4 (6.5%) Above poverty line 49 (90.7%) 41 (69.5%) 58 (93.5%) Diet Vegetarian 12 (22.2%) 28 (47.5%) 30 (48.4%) Nonvegetarian 42 (77.8%) 31 (52.5%) 32 (51.6%) Prakriti Vataja 2 (3.7%) 1 (1.7%) Pittaja 9 (16.7%) Kaphaja Vata-Pittaja 24 (44.4%) 30 (50.8%) 36 (58.1%) Pitta-Kaphaja 11 (20. 4%) 18 (30.5%) 26 (41.9%) Vata-Kaphaja 1 (1.9%) 8 (13.6%) Sannipataja 7 (13.0%) 2 (3.4%) Patients completing the trial from different geographical locations Delhi 10 (18.5%) 28 (47.4%) 62 (100%) Bihar (Patna) 40 (74.0%) 31 (52.5%) Table 4: Efficacy and safety profile of the patients with AC, DES, and CVS AC DES CVS Parameters BT AT p-value BT AT p-value BT AT p-value Serum cholesterol (mg/dl) 185.03 (26.766) 185.90 (25.871) 0.718 179.97 (34.902) 180.32 (34.514) 0.897 150.73 (38.383) 149.50 (33.568) 0.776 Serum triglycerides (mg/dl) 108.13 (32.912) 106.24 (33.673) 0.701 126.24 (53.773) 127.22 (47.886) 0.867 93.52 (49.791) 94.61 (53.910) 0.806 Low-density lipoprotein (mg/dl) 115.208 (18.884) 116.97 (18.943) 0.325 116.93 (24.206) 116.83 (21.385) 0.976 89.68 (29.212) 97.10 (33.980) 0.127 High-density lipoprotein (mg/dl) 51.03 (4.654) 50.45 (4.497) 0.417 46.52 (9.030) 46.92 (6.458) 0.747 46.73 (9.941) 47.89 (8.588) 0.297 Very low density lipoprotein (mg/dl) 21.15 (6.559) 20.67 (6.737) 0.626 24.68 (9.639) 25.15 (9.537) 0.646 18.96 (9.991) 18.79 (11.092) 0.850 LFT Serum bilirubin (Indirect) (mg/dl) 0.31 (0.072) 0.33 (0.131) 0.118 0.35 (0.140) 0.36 (0.253) 0.546 0.43 (0.419) 0.39 (0.262) 0.379 Serum bilirubin (Direct) (mg/dl) 0.50 (0.173) 0.51 (0.154) 0.540 0.42 (0.223) 0.42 (0.191) 0.949 0.31 (0.144) 0.307 (0.161) 0.481 SGPT (IU/L) 34.20 (10.164) 38.24 (17.234) 0.071 38.29 (16.357) 37.37 (17.586) 0.682 31.95 (15.214) 32.05 (22.071) 0.974 SGOT (IU/L) 20.80 (5.318) 22.96 (7.400) 0.019 23.47 (7.632) 24.17 (8.579) 0.475 25.84 (9.621) 28.65 (21.744) 0.273 Serum alkaline phosphatase (IU/L) 275.31 (206.964) 230.85 (169.968) 0.012 165.56 (94.279) 145.07 (68.311) 0.022 94.20 (26.721) 94.61 (37.083) 0.917 Total protein (gm/dl) 7.54 (0.505) 7.60 (0.462) 0.446 7.55 (0.589) 7.37 (0.466) 0.012 7.10 (0.733) 7.02 (0.459) 0.463 Albumin (gm/dl) 4.29 (0.340) 4.28 (0.287) 0.756 4.27 (0.306) 4.20 (0.277) 0.052 4.51 (0.413) 4.52 (0.266) 0.808 Globulin (gm/dl) 3.24 (0.442) 3.30 (0.373) 0.364 3.27 (0.489) 3.18 (0.415) 0.094 2.60 (0.540) 2.50 (0.380) 0.238 KFT Blood urea (mg/dl) 25.01 (5.931) 25.87 (5.863) 0.448 25.19 6.360) 24.44 (6.582) 0.482 21.60 (5.826) 20.40 (5.653) 0.062 Serum creatinine (mg/dl) 0.81 (0.100) 0.85 (0.119) 0.007 0.87 (0.136) 0.90 (0.145) 0.078 0.92 (0.199) 0.91 (0.177) 0.845 Uric acid (mg/dl) 4.78 (0.933) 4.97 (0.920) 0.104 4.61 (0.918) 5.06 (0.942) 0.001 4.89 (1.507) 4.88 (1.343) 0.957

Clinical Safety of Selected Ayurvedic Formulations Graph 1: Comparison of LFTs (SGOT, SGPT) before and after the trial in AC, DES, and CVS Graph 2: Comparison of LFT (serum alkaline phosphatase) before and after the trial in AC, DES, and CVS Study II: Effect of Mahatriphaladya ghrita in DES Oral administration and topical treatment (Tarpana) with Mahatriphaladya ghrita for 84 days revealed significant improvement in the common complaints, such as feeling of dryness in the eyes (<0.001), stuck eyelids (<0.001), burning sensation (<0.001), foreign body sensation (sandy/scratchy/itching) (<0.001), rough lids/mucoid discharge/mild blepharitis (<0.001), pricking pain (<0.001), blurred vision (<0.001), inflammation/redness (<0.001), and narrowing of palpebral aperture (<0.001) faced by patients suffering from DES. Among the total 59 patients, who completed the trial, the majority were females and 50.8% of patients were belonging to Vata-Pittaja Prakriti. About 86.4% were literate and 30.5% hailed from the lower socioeconomic stratum. About 47.5% were vegetarians. The therapy also provided statistically significant changes in serum lipid profile (serum cholesterol, serum triglycerides, and low-density lipoprotein). Serum bilirubin, SGPT, SGOT, serum alkaline phosphatase, total protein, serum albumin, serum globulin, blood urea, and serum creatinine were within normal limits during the entire period and the values were compared with paired t-test before and after the trial. There was no clinical change in these parameters. No adverse drug reactions or adverse events were observed during the study (Tables 3 and 4, Graphs 1 to 4). Graph 3: Comparison of LFT (total protein, globulin, and albumin) before and after trial in AC, DES, and CVS Journal of Research in Ayurvedic Sciences, October-December 2017;1(4):223-230 227

Shruti Khanduri et al Graph 4: Comparison of KFT (blood urea, S. creatinine, and uric acid) before and after the trial in AC, DES, and CVS Study III: Effect of Mahatriphaladya ghrita and Anu taila in CVS Oral administration and topical (Tarpana) use of Mahatriphaladya ghrita for 42 days and Anu taila Nasya for 7 days revealed significant improvement in the common complaints, such as eye strain and fatigue (<0.001), headache (<0.001), double vision (<0.001), neck and shoulder pain (<0.001), dry and irritated eyes (<0.001), blurred vision (<0.001), redness of eyes (<0.001), excessive tearing (<0.001), and photophobia (<0.001) faced by patients suffering from CVS Further, values of Schirmer s I test from the baseline to 42th day showed significant increase (p >0.001). Among the total 62 patients who completed the trial, the majority were males and 58.1% of patients were belonging to Vata-Pittaja Prakriti. About 100% were literate and 6.5% hailed from lower socioeconomic stratum. About 48.4% were vegetarians. The therapy also provided statistically significant changes in serum lipid profile (serum cholesterol, serum triglycerides, and low-density lipoprotein). Serum bilirubin, SGPT, SGOT, serum alkaline phosphatase, total protein, serum albumin, serum globulin, blood urea, and serum creatinine were within normal limits during the entire period, and the values were compared with paired t-test after the trial. There was no detectable change in these parameters. No significant adverse drug reactions or adverse events were observed during the study (Tables 3 and 4, Graphs 1 to 4). All the three studies were registered in the Clinical Trial Registry of India. The data regarding demographic profile, efficacy and safety, obtained from the three studies, are given in Tables 3 and 4, Graphs 1 to 4. DISCUSSION This study was to assess the safety profile of these drugs by analyzing the liver function and kidney function 228 before and after the trial. Drug compliance and development of adverse effects, if any, were scrutinized. In-depth observations revealed that blood urea, serum uric acid, serum creatinine, total protein, serum globulin, serum albumin, SGOT, SGPT, and bilirubin levels in the body were within the range at the end of the treatment. The patients were closely monitored and no adverse events/ adverse drug reactions were reported during the trial period in the case of all three formulations and, hence, Mahatriphaladya ghrita, triphala khwath, and Anu taila can be said to be clinically safe and effective in common eye diseases. The AC is an inclusive term that encompasses many allergic conditions that cause the symptoms of conjunctivitis, and is very common in children and adult population alike. The DES is a common disorder, which presents with dryness of eyes and gritty sensation in the eyes. The additional symptoms include burning or itching in the eyes, foreign body sensation, excess tearing, pain, and redness of the eyes, and photophobia. Computer vision syndrome is clinically similar to dry eye. Visual complaints include blurred vision, and ocular symptoms associated with the syndrome include sensations of burning, stinging, and photophobia. With the advent of technologies, such as the computer and mobile, improper dietetics, and lack of proper eye care, these conditions are on the rise. Ayurveda has a broad scope in this area, owing to its unique preventive and curative aspects. In the above three studies, the prakrti of these patients was observed to be Vata Pittaja predominantly and followed by Pitta Kaphaja prakrti. In DES, females were more affected and males were most affected in case of AC and CVS. The CVS was seen only in educated persons as it often comes with the increased use of the computer. This study provides evidence in support of the potential safety and efficacy of three formulations that are specific to ophthalmic care: Mahatriphaladya Ghrita,

Clinical Safety of Selected Ayurvedic Formulations Triphala Kwath, and Anu Taila in subjects suffering from common eye diseases. Ghrita is Vata Pitta Shamak and Triphala is Tridosh Shamak. Mahatriphaladya ghrita has a rejuvenating effect on eyes and is used for preventing and managing eye diseases. In these studies, significant changes were noticed in the above-mentioned qualitative parameters of AC like redness, anxiety, lacrimation, photophobia, burning sensation, and foreign body sensation, as assessed by statistical evaluation, which showed a p-value <0.001. In symptoms of DES like dryness of eye, pricking pain, mucoid discharge, stuck eyelids, blurred vision, burning sensation, and foreign body sensation, statistically significant change was observed as assessed by the statistical evaluation, which showed p-value <0.001. Also, in symptoms of CVS, like redness, headache, excessive tearing, blurred vision, dry and irritated eyes, neck and shoulder pain, double vision, photophobia, eye strain, and fatigue, statistically significant changes were observed as assessed by statistical evaluation, which showed p-value <0.001. CONCLUSION The study to evaluate the safety and efficacy of Mahatriphaladya ghrita, triphala kwatha, and Anu taila was conducted at two peripheral institutes of CCRAS. The analysis of outcome of these scientifically planned studies demonstrates that despite the differences in gender, socioeconomic status, age group, and Prakrti, Mahatriphaladya ghrita, triphala kwatha, and Anu taila proved to be very much safe, effective, and tolerable in the management of common eye diseases. No adverse events or adverse drug reactions pertaining to drug interaction were noticed during the trial period. REFERENCES 1. La Rosa M, Lionetti E, Reibaldi M, Russo A, Longo A, Leonardi S, Tomarchio S, Avitabile T, Reibaldi A. Allergic conjunctivitis: a comprehensive review of the literature. Ital J Pediatr 2013 Mar;39:18. 2. Phadatare SP, Momin M, Nighojkar P, Askarkar S, Singh KK. A comprehensive review on dry eye disease: diagnosis, medical management, recent development, and future challenges. Adv Pharm 2015 Jan;2015:704946. 3. Ohashi Y, Ishida R, Kojima T, Goto E, Matsumoto Y, Watanabe K, Ishida N, Nakata K, Takeuchi T, Tsubota K. Abnormal protein profiles in tear with dry eye syndrome. Am J Ophthalmol 2003 Aug;136(2):291-299. 4. Wimalasundera S. Computer vision syndrome. Galle Med J 2009 Sep;11(1):25-29. 5. Blehm C, Vishnu S, Khattak A, Mitra S, Yee RW. Computer vision syndrome: a review. Surv Ophthalmol 2005 May- Jun;50(3):253-262. 6. Hazarika AK, Singh PK. Computer vision syndrome. SMU Med J 2014 Jul;1(2):132-138. 7. Vaidya, BHP. Ashtanga Hridaya by Vagbhata, with commentaries of Arunadatta and Hemadri chapter 15/16 utharasthana. 8th ed. Varanasi: chaukhambha orientalia. 8. Sushrut Samhita, uttartantram, sarvagatrog vidyaniya 6/16. p. 1100. 9. Leonardi S, Marchese G, Marseglia GL, La Rosa M. Montelukast in allergic diseases beyond asthma. Allergy Asthma Proc 2007 May-Jun;28(3):287-291. 10. Anonymous. The Ayurvedic Pharmacopoeia of India (Ministry of Health and Family Welfare, Govt. of India, New Delhi): part II. 1st ed. Vol. 2. New Delhi: The Controller of Publications; 2010. 11. Anonymous. The Ayurvedic Formulary of India (AFI) (Ministry of Health and Family Welfare, Govt. of India, New Delhi): part II. 1st ed. New Delhi: The Controller of Publications; 2000. p. 71. 12. Anonymous. The Ayurvedic Pharmacopoeia of India (Ministry of Health and Family Welfare, Govt. of India, New Delhi): part II. 1st ed. Vol. 3. New Delhi: The Controller of Publications; 2010. Journal of Research in Ayurvedic Sciences, October-December 2017;1(4):223-230 229

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