journal of pharmaceutical and scientific innovation gouri et al: avipattikar choorna and sutasekhar...

Chauhan Gouri et al: Avipattikar choorna and Sutasekhar rasa in the management of Urdhwaga amlapitta

JPSI 4 (1), Jan -Feb 2015 1

Journal of Pharmaceutical and Scientific Innovation

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Research Article

STUDY ON CLINICAL EFFICACY OF AVIPATTIKAR CHOORNA AND SUTASEKHAR RASA IN THE MANAGEMENT OF URDHWAGA AMLAPITTA Chauhan Gouri1, Mahapatra Arun Kumar2*, Babar Kapoor Alka1, Kumar Abhimanyu3 1Clinical Specialist, Department of Kayachikitsa, All India Institute of Ayurveda, Mathura Road, Gautampuri, New Delhi, India 2Clinical Specialist, Department of Kaumarbhritya, All India Institute of Ayurveda, Mathura Road, Gautampuri, New Delhi, India 3Director, All India Institute of Ayurveda, Director General, Central Council for Research in Ayurvedic Sciences (CCRAS), New Delhi, India *Corresponding Author Email: [email protected] DOI: 10.7897/2277-4572.0414 Received on: 28/11/14 Revised on: 09/01/15 Accepted on: 02/02/15 ABSTRACT The disease Amlapitta is a frequent presentation in clinical practice. Excess formation of vitiated pitta (Pitta Drava guna vridhi) due improper dietary and lifestyle habits is thought to be the main pathological mechanism behind manifestation of this disease. Classical Ayurvedic formulations like Avipattikar choorna and sutasekhar Rasa are often prescribed in combination for its effective management. The present study was conducted to evaluate the efficacy of both these classical formulation in the management of urdhwaga Amlapitta. The study was a single arm, open clinical trial involving 133 patients of Amlapitta attending the OPD of All India Institute of Ayurveda, New Delhi, India. All patients were screened on the basis of classical clinical findings of Amlapitta and were administered with a combination of sutasekhar rasa (125 mg twice a day orally after principal meals) and Avipattikar choorna (5 g twice a day orally after principal meals) for 04 weeks period. Scoring scale based on classical clinical features of Amlapitta was adopted for the assessment of the disease. Routine pathological tests such as blood, urine, stool, etc. were carried out. During the study, 20 patients dropped out and 113 patients were followed. After 04 weeks of treatment, Improvement in clinical features like Hrit-Kantha Daha, Tikta-Amla Udgaar, Aruchi, Utklesha, Avipaak, Gurutaa and Klama was found to be statistical significant (p ≤ 0.05). No adverse event was observed during the administration of trial drugs. Keywords: Amlapitta, Avipattikar choorna, sutasekhar rasa, Ayurveda INTRODUCTION Amlapitta is a commonly encountered disease of Annavaha srotas (Gastrointestinal system). This disease has been described in detail in classical Ayurvedic texts like Kashyap samhita1, Yogaratnakar2 and Bhaisajyaratnawali3 etc. It is characterized by cardinal features like Avipaak (Indigestion), Klama (Tiredness), Utklesa (Nausea), Tikta-Amla Udgaar (Sour and bitter belching), Gauravata (Heaviness), Hrit-Kantha Daha (Heart and throat burn) and Aruchi (Anorexia)4 Excess formation of vitiated pitta is thought to be the main pathological mechanism behind manifestation of this disease. The pitta is vitiated as a result of improper dietary and lifestyle habits. Clinical features of Amlapitta closely resemble with a condition known as Non ulcer dyspepsia or Functional dyspepsia.5 The exact data on the prevalence of amlapitta is not available till date. However, Dyspepsia is reported to be accounting for only 5 % of consultation in family practice.6 Community based studies reveal the prevalence of dyspepsia ranging from 19 % to as high as 41 % in the population.7,8 Aims and objectives The aim of this study is to evaluate the efficacy of the Avipattikar choorna and Sutasekhar rasa in management of urdhwaga Amlapitta. MATERIALS AND METHODS Study design Present study was an open, single arm clinical trial. Patients attending O.P.D. of All India Institute of Ayurveda, New Delhi, India with clinical symptoms of Urdhwaga Amlapitta were included into the study. A total of 133 patients of age above 18 years, of

either sex, satisfying the inclusion criteria were finally enrolled in the study after through baseline screening. Informed consent was taken from the patient before including them in the trial. All the patients were administered with a combination of Sutasekhar Rasa and Avipattikar Churna 30 minutes after principal meals. The patients were registered and their data for demographic and clinical profile was maintained. The drugs were given with follow ups every week for duration of four weeks. Inclusion criteria Patients aged above 18 years of either sex, with cardinal features of amlapitta like Avipaak (Indigestion), Klama (Tiredness), Utklesa (Nausea), Tikta-Amla Udgaar (Sour and bitter belching), Gauravata (Heaviness), Hrit-Kantha Daha (Heart and throat burn), Aruchi (Anorexia) and those patients who were willing to give written consent to participate in the study were included in the study. Exclusion criteria Subjects with age below 18 years, Patients with poorly controlled Hypertension (> 160/100 mm of Hg), Patients with Diabetes Mellitus {Blood Sugar-Fasting > 126 mg% and / or Blood Sugar-2 hour Post Prandial) > 200 mg% or HbA1c > 6.5 %}, Patients on prolonged (> 6 weeks) medication with H2 Blockers, Antacids, corticosteroids, antidepressants, anti-cholinergics, etc. or any other drugs that may have an influence on the outcome of the study, Patients with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) > 2 times upper normal limit) or Renal Disorders (defined as S. Creatinine > 1.2 mg/dL), Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive


JPSI 4 (1), Jan -Feb 2015 Page 12

Pulmonary Disease [COPD]), or any other condition that may jeopardize the study, Patients with evidence of malignancy, Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months, Patient with any GI complications like peptic ulcer, duodenal ulcer, perforation, stenosis, bleeding, malaena, malignancy etc., subjects with history of hypersensitivity to any of the trial drugs or their ingredients, Pregnant / lactating woman and Patients who have completed participation in any other clinical trial during the past six (06) months were excluded from the study. A total of 133 patients of age above 18 years, of either sex, satisfying the inclusion criteria were finally enrolled in the study. During the study, 20 patients dropped out and only 113 were followed till the end. Trial drug and Posology Patient enrolled in the study were administered with combination of sutasekhar rasa and avipattikar choorna. Formulation of Sutasekhar Rasa Sutshekhar Rasa contains Sodhita Parad (Purified Mercury), Sodhita Gandhak (Purified Sulfur), Sodhita Makshik (Chalcopyrite), Shankh Bhasma (conch shell), Tamra bhasma (Copper), Tankan (Borax), Sodhit vatsanava (Purified Aconitum ferox), Sodhit Dhatura (Purified Dhatura metel), Shunthi (Zingiber officinale), Maricha (piper nigrum), Pippali (piper longum), Twak (Cinnamomum zeylanicum), Patra (Cinnamomum tamala), Ela (Eletaria cardamomum), Nagakeshar (Messua ferrae), Bilwa majja (Aegle marmelos), and Bhringaraj swarasa (Eclipta alba)9 Formulation of Avipattikar choorna Avipattikar churna consists of fourteen ingredients viz., Sunthi (Zingiber officinale), Maricha (Piper nigrum), Pippali (Piper longum), Haritaki (Terminalia chebula), Bibhitaki (Terminalia bellirica), Amalaki (Embelica officinalis), Mustaka (Cyperus rotundus), vida lavana, Vidanga (Embelia ribes), Ela (Elettaria cardamomum), Twak (Cinnamomum tamala), Lavang (Syzgium aromaticum), Trivrit (Operculina terpethum) and Sharkara (Saccharum officinarum)10

Dose of trial drug · Sutasekhar Rasa: 125 mg twice a day 30 minutes after

principal meals · Avipattikar choorna: 05 g twice a day 30 minutes after

principal meals All the medicines were supplied by the Indian Medicines Pharmaceutical Corporation Limited (A Government of India Enterprise) Mohan - Dist. Almora (via-Ramnagar-244715), Uttarakhand, India. Duration of treatment: 04 weeks Diet: Patients were kept under normal diet with special restriction of Spicy and oily diet. A copy of diet chart was given to each patient. Follow-up: The patients were followed-up once in seven days up to 28 days. Laboratory Investigations · Routine hematological investigations - Hb, TC, DC, E.S.R.,

P.C.V. · Urine examination - Routine and Microscopic. · Stool examination - Routine and Microscopic.

· Biochemical examination - FBS, Sr. Cholesterol, Sr. Triglycerides, HDL, Blood Urea, Sr. Creatinine, S.G.P.T., S.G.O.T., Sr. Total Proteins, Albumin, Globulin, A/G Ratio, Sr. Alkaline Phosphate, Bilirubin (T), Bilirubin (D), Sr. Uric acid.

All above mentioned laboratory investigations were carried out before and after treatment. Criterion for assessment Amlapitta was diagnosed according to the classical clinical features such as Avipaak (Indigestion), Klama (Tiredness), Utklesa (Nausea), Tikta-Amla Udgaar (Sour and bitter belching), Gauravata (Heaviness), Hrit-Kantha Daha (Heart and throat burn) and Aruchi (Anorexia) on four point grade scale (G0 – G3).4

Table 1: Grading of clinical features of Amlapitta according to severity

Grades of severity

Characteristics

Avipaak G0 no indigestion G1 digests normal usual diet in 09 hours G2 digests normal usual diet in 12 hours G3 digests normal usual diet in 24 hours or more

Klama G0 no tiredness G1 feel tired after exertion work G2 feel tired after normal work G3 feel tired even after taking rest

Utklesha G0 no nausea G1 Feel nausea after eating some peculiar food G2 feel nausea after eating all kinds of food G3 full day nausea, not related to eating

Tikta amla udgaar G0 no sour and bitter belching G1 sour and bitter belching after taking spicy food G2 sour and bitter belching after taking any type of food G3 sour and bitter belching having no relation with food

intake Guruta

G0 no feeling of heaviness in the body G1 heaviness after taking more quantity of heavy food G2 heaviness even after taking light food G3 heaviness even on empty stomach

Hrit-Kantha Daha G0 no Burning sensation G1 burning sensation after intake of spicy food G2 feeling of burning sensation even after intake of

normal food G3 burning sensation even empty stomach

Aruchi G0 no anorexia G1 eat food only two times without any snacks in

between G2 eat only once G3 have no feeling of appetite

Statistical analysis The data generated during the study was subjected to Wilcoxon sum rank test to assess the statistical significance between before and after the administration of trial drugs. OBSERVATIONS AND RESULTS In the present study, it was observed that out of total 113 patients, 85 (75.22 %) were males and 28 (24.78 %) were females. Age wise distribution study reveals 07 patients (6.19 %) in age group 18-20 years, 17 patients (15.04 %) in age group 21-25 years, 11 patients (9.73 %) in age group 26-29 years, 28 patients (24.78 %) in age group 30-35 years, 15 patients in age group 36-40 years, 17 patients



(15.04 %) in age group 41-45 years, 08 patients (7.08 %) in age group 46-50 years, 05 patients (4.42 %) in age group 51-55 years, 02 patients (1.77 %) in age group 61-65 years, 01 patients (0.88 %) in age group 66-70 years and 02 patients (1.77 %) in age group 76-80 years. Regarding occupation wise distribution, it was observed

that out of total patients, 30 patients (26.5 %) were doing office work, 31 patients (27.43 %) were field workers, 23 patients (22.12) were house wives, 11 patients (9.73 %) were student, 10 patients (8.85 %) were teachers, 04 patients (3.54 %) were doing business and 02 patients (1.77 %) were doing some other jobs.

Table 2: The pattern of nidan sevan in patients with amlapitta

S. No. Nidan Number of patients Percentage 1 Ati Lavan-Amla-Tiksha ahaar sevan 65 57.52 2 Ati ushna bhojan 33 29.20 3 Adhyashana 45 39.82 4 Irregular diet 47 41.59 5 Addiction of tea 79 69.91 6 Addiction of smoking 61 53.98 7 Addiction of tobacco chewing 48 42.47 8 Diva swapna 41 36.28 9 Raatri jaagran 40 35.39 10 Vega vidhaarana 38 33.62

Table 3: Clinical features of Amlapitta in patients observed during baseline evaluation (N = 113)

S. No. Clinical features Total number of patients Percentage

1 Hrit-Kantha Daaha 113 100 2 Tikta-Amla Udgaar 105 92.92 3 Aruchi 88 77.88 4 Utklesha 47 41.59 5 Avipaak 72 63.72 6 Gurutaa 71 62.83 7 Klama 50 44.25

Table 4: Statistical analysis of improvement in clinical features of Amlapitta after 04 weeks of treatment

S. No. Clinical features Mean diff. Sum of positive ranks

Sum of negative ranks

Sample size (w) Mean (w) SD (w) ‘z’ value

1 Hrit-Kantha Daha 2.1 6441 0 113 32220.5 349.06 -9.23* 2 Tikta- Amla Udgaar 1.81 5356 0 105 2678 303.96 -8.81* 3 Aruchi 1.47 3916 0 88 1958 240.34 -8.15* 4 Utklesha 1.17 1081 0 46 540.5 91.53 -5.91* 5 Avipaaka 1.47 2628 0 72 1314 178.2 -7.37* 6 Gauravataa 1.34 2556 0 71 1278 174.53 -7.32* 7 Klama 0.28 820 0 40 410 74.4 -5.51*

Mean diff. = Mean difference, SD = standard deviation, * = Significant at 5 % level

After 04 weeks of treatment, statistical significant results were observed in all the features of Amlapitta. No significant difference was observed in the mean change of hematological and bio chemical parameters after the drug administration. DISCUSSION Amlapitta is a common gastric problem that is usually related with the food habits and lifestyle. In the present study, there were 85 males (75.22 %) and 51 females (24.78 %) in total. Previous study conducted by Baragi et al (2012) also reported male predominance in disease Amlapitta11. It was observed that out of 113 patients, maximum patients i.e. 28 (24.78 %) belonged to age group 30-35 years. The mean age of patients was found to be mean age of 36.3 years. Madhyamavastha is considered as pitta prakopa vaya and thus, this age group is more prone to suffer to pitta predominant diseases. Regarding occupation wise distribution of patients, it was observed that, out of 113 patients, majority of patients (27.43 %) were involved in field work. On analyzing the symptomatology of amlapitta, Hrit Kantha Daha was found to be present in all (100 %) registered patients, while Tikta-amla udgaar in 92.92 % patients, Aruchi in 77.88 % patients, Avipaak in 63.72 % patients, Gurutaa in 62.83 % patients, Klama in 44.25 % patients and utklesha was found in 41.59 % patients. These findings are in correlation with previous study conducted by Kumar et al (2011) in which hrid daha was evident in 68.29 % patients, kukshi daha in 73.17 %, Urah daha in 51.22 % and kantha daha in 46.34 % patients suffering from

amlapitta.12 Significant improvement was observed following 04 weeks of administration of drugs in all assessment parameters of amlapitta. The trial drug Avipatikar churna has fourteen ingredients with having lavang (Syzygium aromaticum), trivrit (Ipomea turpethum) and sharkara (cane sugar) as its main constituents. It is indicated in indigestion, constipation, acidity, piles and diabetes. In amlapitta there is increase in amount of vitiated pitta that causes the symptoms of indigestion, sour and bitter belching, heartburn, anorexia etc. Avipattikar choorna mainly by its deepan, pachan and sarak guna normalizes the vitiated pitta and eliminate the extra pitta from the body by its laxative action. In the initial stage of Amlapitta, due to vitiation of Pitta there is manifestation of Vidagdhajeerna which may later causes inflammation and corrosion of the Sleshmadhara kala of the Amashaya i.e. mucous membrane of the stomach and duodenum13.

Studies on efficacy of Avipattikar churna on Amlapitta disease are very less. Research evidences shows that, Avipattikar churna possess significant gastro-protective activity. Oral administration of aqueous extract of Avipattikar churna in a dose of 500 mg/kg significantly provides protection against gastric lesions as compared to ranitidine in ibuprofen, ethanol and pylorus ligation induced ulcer models. Besides this, Histopathological examination of stomach mucosa showed the protective action against mucosal epithelial damage. Reduction in acid secretory parameters (i.e. total and free acid), gastric volume and gastric irritancy index was also demonstrated.14



In vitro analysis reveals that Aqueous and methanolic extracts of Avipattikar churna possess antioxidant activity.15 One of the ingredient of avipattikar churna is maricha (Piper nigrum). In a study, five phenolic amides from Piper nigrum found to possess significant antioxidant activities that are more effective than the naturally occurring antioxidant, alpha-tocopherol.16 Another important ingredient of avipattikar choorna is Trivrit (Operculina terpethum Linn.) Experimental study shows that hydroalcoholic and methanolic extract of stem bark extracts of Operculina turpethum possess enhanced ulcer preventive and protective activities when compared with the standard drug ranitidine. Extracts of Operculina turpethum were administered in a dose of 100 mg/kg, body weight orally and effects were evaluated employing aspirin pylorus ligation model in experimental rats.17 Sutasekhar rasa (without gold) contain 16 ingredients. It is indicated in acidity, vomiting, gas formation, cough, sprue and diarrhea. It has anti-secretory property along with this it also normalizes the vitiated pitta of the body especially of GI tract when there is hyper secretion of acid in the tract it reduces its secretion. The Bhavna dravya (triturating medium) of trial drug Sutasekhar Rasa is Bhringaraj (Eclipta alba). The disease Amlapitta manifests as a result of abnormal functioning of pitta and particularly, the dravatva guna of pitta is increased.18 The drug Bhringaraj (Eclipta alba) possess ruksha and ushna properties19 and by virtue of both these properties, it reduces the abnormally increased dravatva of pitta, and helps in managing amlapitta. A recently randomized open clinical trial reported significant improvement in amlapitta features with administration of Bhringaraj tablets for duration of 04 weeks.20 Other ingredients of sutasekhar rasa like Dhatura, Vatsanabh also helps in reducing the dravatva of the vitiated pitta and thus managing amlapitta. The role of pathya diet is the most vital step in the management of Amlapitta. Thus, the patients were instructed about the proper dietetic regimen to follow. In pathya, they were advised to take coconut water, unripe coconut, coconut petha (Sweet made up of coconut) (Cocos nucifera) milk, ghee, old rice, mix dal (Legumes), roti, vegetable like patola (Trichosanthes dioica) etc. and fruits like apple, banana, pomegranate etc. In apathy ,it was advised not to take spicy food, oily food, fried food, street road food, sour item like vinegar, lemon juice, curd, tomato etc, more salty food, bitter like chillies etc, ginger, garlic hot drinks like coffee, tea, tobacco, alcohol, Betel leaves chewing was also not permitted. It was observed that when the patient were given the treatment with advice to follow the pathya and apathy, their recovery from the disease was very much satisfactory and also there was reduced chance of recurrence of the disease. CONCLUSION Amlapitta is a chronic recurring condition of gastrointestinal system and affects quality of life of patients. It is caused by the faulty life style habits like Ati Lavan-Amla-Tiksha ahaar sevan (excessive intake of salty, sour, pungent food articles), Ati ushna bhojan (excessive intake of hot food stuff), Irregular diet, Raatri jaagran (Not sleeping at night), Vega vidhaarana (holding of natural urges) and Diva swapna (Day time sleep (Table 1). This causes vitiation of the dosha (Pitta) in body and ultimately leads to manifestation of the disease. Young age people are more prone to suffer from this disease as evident from the present study as well as prior researches on this disease. Addiction like tea, smoking and Tobacco chewing play an important role in causing and aggravating the disease. (Table 1) The combination of avipattikar churna with sutasekhar rasa is very effective in managing urdhwaga amlapitta. Both the drugs are free from side effects. Moreover, by abiding the Pathya and avoiding Apathya aahaar-vihaar patients have faster recovery and have reduced at chance of recurrence.

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Source of support: CCRAS, Conflict of interest: None Declared

How to cite this article: Chauhan Gouri, Mahapatra Arun Kumar, Babar Kapoor Alka, Kumar Abhimanyu. Study on clinical efficacy of Avipattikar choorna and Sutasekhar rasa in the management of Urdhwaga amlapitta. J Pharm Sci Innov. 2015;4(1):11-15 http://dx.doi.org/10.7897/2277-4572.0414

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