Fundamental and Clinical Study to Evaluate Efficacy of Drakshadya Ghrita on Amlapitta

Introduction: Ayurveda's fundamental concepts are based on the Sankhya philosophy of universe creation, according to which man is a Microcosm of a Universe within himself. The introduction of external factors into the human body's internal environment happened by AGNI (Digestive element ). All diseases are caused by to defacement of Agni . (1) Also Amlapitta is a disease caused by a disruption in the Agni level. The classical literature on Amlapitta explains that Amlapitta is such a condition in which Drava guna and Amlaguna (sourness) of Pachak Pitta (Gastric juice ) increase which is normal for Katu rasa (bitter taste). (2) Aacharya Vagbhat in Ashtang Hriday Samhita has explained basic fundaments for Vataj, Pittaj, and Shleshmajvyadhichikitsa. Ghrita is par excellent ( parma-aushadha ) Shamana Dravya for pitta Dosha . (3) DrakshadyaGhrita is the most effective formulation of Ghrit Kalpana mentioned for Amlapitta in Yogratnakar Samhita. (4) Material and Method: DrakshadyaGhrita was prepared by Yogratnakar Formulation. Open Clinical trial of DrakshadyaGhrita was conducted on 45 patients of given inclusion criteria for 10 days with these Assistment criteria - Hrutkanthdaha, Avipaka, Utklesh, Amlodgar, Gaurava, Agnimandya. Observation and Result : Effect on Agnimandya symptoms, Mean 1.06 before treatment which is reduced to 0.11, SD score was 0.96 before treatment which is reduced to 0.31 and Median score was 1 reduced to 0 after treatment after follow-up up with 89.62 % improvement, and there is a statistically significant change (p<0.0001 HS). Discussion: Patients had shown improvement in all the criteria of assessment of Amlapitta. No adverse effect was observed. Thus DrakshadyaGhrita can be recommended for the management of Amlapitta.

Introduction:Ayurveda's fundamental concepts are based on Balanced Agni is the key to living a long , healthy and fulfilling life whereas impaired Agni is a surefire way to court imbalance , disease and discontent.Amlapitta is a disease of Annavahastrotas (5) (Digestive System )occurs by the vitiation of Athat can be found in any corner of the world .People now a days practise incorrect nutrition and lifestyle due to a lack of understanding of AshtauAahar Vidhi Vishesha Ayatan (Concept of Dietics ) (6) , AaharvidhiVidhan (Concepts of food intake ) (7),Viruddhahara (incompatible food ) (8) and Asatmya Ahara ,Improper following of Dincharya and Rutucharya.However, in this fast-food era, people are willing to overlook everything in order to attain their goal .No gain without pain , So Hurry, worry, stress, strain, and anxiety are all on the table.All of them accelerate the vitiation of dosha by disturbing action of Agni leads resulting in Hrutkanthdaha ,Amlodgaar, Avipaka like symptoms.(9) This is in most cases due to excessive secretion of acidic material in the stomach.In Ayurvedic terminology , this is reffered as Amlapitta , where vitiation of Pitta Dosha occurs along with kapha Dosha (10) According to Modern therapy it is better to consider Amlapitta as a syndrome (acid reflux syndrome) (11) rather than a particular gastrointestinal disease.Sign and Symptoms of Amlapitta closely resembles with gastritis,(12) non-ulcer dyspepsia ,(13) hyperchlorhydria, (14) as well as hypochlorhydria (15) and in chronic stage, it may lead to gastric ulcer.Modern medicine use H2 blockers and proton pump inhibitors for symptoms of this disease, which shows remarkable relief in symptoms, but long term use of H2 blockers and proton pump inhihibitors causes side effects like dizziness, headache, gynacomastia, loss of libido, temporary oligospermia ,atropicgastritis etc.( 16) The disease's peculiarities include its high prevalence, wide range of symptom manifestations, and the need for long-term dietary control.If not treated in a timely manner, it can lead to serious complications, and relapses are common.In a demographic survey, its prevalence range observed is about 11% to 38.8% of world population.(17)Rapidsocioeconomic development and the westernization of Asian lifestyles, including changes in diet and an increase in average body mass index , are likely to be the key factors in change in epidemiology.
Even though Amlapitta is not a dreadful disease but it hampers day to day activity of the patient.This work was aimed to see the efficacy of DrakshadyaGhritain Amlapitta as Shamakyoga.Contents of this Yoga are easily available , cost effective and easy for preparation because of all these reason this formulation was selected.
Aim: To evaluate, Fundamental and clinical efficacy of DrakshadyaGhritain Amlapitta .

Objectives:
1. To study fundaments about the efficacy of DrakshadyaGhritain Amlapitta.DrakshadyaGhrita which is described under Amla Pitta ChikitsaRogadhikar of Yogratnakar was taken as trial drug in the present study.

2.Collection of Raw Drug :
Raw drugs were collected from the Manas Ayurved ,Ghatate Layout , Civil lines , Nagpur.

3.Identification and Authentification :
Raw drugs of Drakshadya Ghrita were identified and authentified by Department of Dravya Guna .

Procedure of making GhritaMurchana :
Kalkawas prepared from all the drugs coarse powder by adding Matulungaswarasa .In a large iron vessel with wide mouth Goghrita was taken and heated over Madhyamagnitill complete evaporation of moisture content become possible at the temperature around 140oC.The Kalka was added to the Ghrita after slight cooling, at temperature around 85oC.When Kalka becomes light brown in color, water was added in proportion to 4 times of Sneha.After addition of water, it was heated on Mandagni with intermediate stirring.Heating duration was adjusted so as to complete the Snehapaka till Sneha Siddhi Lakshana appeared and then SnehaPaka is complete.Then vessel was taken out from the fire and Ghritawas filtered through clean cloth in its mild hot stage.Murchita Sneha was stored in a glass jar container after cooling .'

Diagnostic Criteria:
Amlapitta affected patients will screen via pre-assessment criteria base on general sign and symptoms of Amlapitta.

Inclusion Criteria:
 Patients age between 18 and 60 years. Patients having signs and symptoms of Amlapittasuch as Daha ,Avipak , Utklesh , Amlodgara , Gaurava , Agnimandya will selected. Patients who gives written consent.

Exclusion Criteria:
 Patients of age <18 years and >60 years. Patients already diagnosed with or having any history of other systemic diseases such as cardiovascular ,nephropathic , neuropathic , Diabetes Mellitus and any type of malignant disorders will excluded.

Statistical Analysis:
Subject parameters will be express in frequency and percentage subjective parameters will be compared before and after treatment by performing wilcoxon sign rank test.P< 0.0.5 will be considering as statistical significance statistical software STATA vention 14.0 will be used for data analysis.DISCUSSION:In this discussion part, the observations of the study was analyzed as follows.

1) Effect on Amlodgara :
This Lakshana is mainly due to Vata Pitta Dosha.When there is Vidagdata andShuktatha of Aahara then there is Amla Udgara.Statistical analysis showed that the mean score which was 1.26 in beforetreatment, was reduced to 0.40 in after treatment , and there is a statistically significant change.(P<0.001)

2) Effect on Hrutkanthdaha:
This Lakshana is mainly due to Pitta Dosha.When there is Vidagdata andShuktathaof Aahara then there is Hrutkanthadaha.Statistical analysis showed that the mean score which was 1.28 in beforetreatment, was reduced to 0.84 in after treatment , and there is a statistically significant change.(P<0.001)

3) Effect of Avipakaain Amlapitta
Avipakaais developed mainly because Kapha Dosha.Statistical analysis showedthat the mean score which was 1.24 in before treatment, was reduced to 0.29 the after treatment and there is a statistically significant change.(P<0.001) 4) Effect of Gaurav in Amlapitta Gauravis developed mainly because Kapha Dosha.Statistical analysis showedthat the mean score which was 1.35 in before treatment, was reduced to 0.20 the after treatment and there is a statistically significant change.(P<0.001) The treatment was given for 10 days with DrakshadyaGhrita as shamanawhich was highly significant.The treatment modalities are safe and are of therapeutic value.The above said observations indicate that patients have shown improvement in all the criteria of assessment of Amlapitta.The therapeutic effects like normalcy of Agni , Gain of strength are due to decrease of the Amlapitta symptoms.The ultimate effect will be curing the Agnimandya and correction of Agni .

CONCLUSION:
The following conclusions are drawn from the clinical study undertaken withShamana in Amlapitta through DrakshadyaGhruta .1. Faulty dietary habits and sedentary lifestyle are main contributing factor in theestablishment of disease.Excess intake of Amla, Katu Rasa Dravyas and food articles like Dadhi, Masha, Drava Aahara were the commonest aetiological factors found in this study.2. The present study was carried for a limited time and it showed encouragingresult.No adverse effects were reported by any of the patients.3. DrakshadyaGhrita gives remarkable improvements in Hrutkanthdaha (88.28%),Avipaka (76.61%),Amlodgar (68.25 %) ,Utklesh (100% ) ,Gaurav (85.19 %) , Agnimandya (89.62 %) and overall effect of treatment 84.65 %.It is statistically significant.4. The present study has shown significant results in all types of Amlapittaandhighly effective in Amlapitta.5.It was found to be effective in Amlapitta of mild and moderate severity.

Stastical presentation of Comparison of mean ,SD , Median score , % Effectiveness of Therapy of Pramukh Lakshanas before and after treatment .
Pittashamakproperties , properties that are opposite to Pitta guna and Karma .Pitta have mildsneha and dravain nature while Ghritacalled Mahasneha (Best in Sneha Dravyas ).The outcomes were measured before and after the completion of the treatment by assessment criteria.Data analysis consisted of two parts,  To describe the characteristics of the subjects by using descriptive methods with help of general points like age, sex, diet, Prakruti, Vyasan, etc  Comparision of before-treatment measurements of the outcomes with that of after-treatment.