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AYUSHDHARA An International Journal of Research in AYUSH and Allied Systems ISSN: 2393-9583 (P)/ 2393-9591 (O) Research Article A CLINICAL TRIAL OF AROGYA VARDHINI VATI AND LEKHANIYA MAHAKASHAYA IN THE MANAGEMENT OF OBESITY V. B. Kumawat 1 *, Bhanupriya Kaushik 2, Rashmi 2, Abhishek Saxena 4, Uttam Kumar Sharma 5 * 1 Research Officer (Ayu.) Scientists-3 M.S. Regional Ayurveda Research Institute for Endocrine Disorders, Jaipur. 2PG Scholar, 5 Professor & HOD, Dept. of Panchkarma, Uttrakhand Ayurved University, Gurukul Campus, Haridwar. 4PG Scholar, Department of Panchkarma, HA(PG)MC & Hospital, Dehradun. KEYWORDS: Arogya Vardhini Vati, Lekhaniya Mahakashaya Obesity. *Address for correspondence Dr. V. B. Kumawat Research Officer (Ayu.) Scientists-3 M.S. Regional Ayurveda Research Institute for Endocrine Disorders, Jaipur. Email: vinodbihari100@gmail.com Ph +918003514251 ABSTRACT Obesity is a condition in which there is an excessive accumulation of fat in the body which is a risk to health. The WHO now considers obesity to be a global epidemic and public health problem. Globally an estimated 300 million adults are now obese and many are overweight. A person with a BMI of 30 or more is generally considered obese. The problem is due to calorie imbalance resulting from an excessive food intake coupled with inadequate exercise. It is associated with increased mortality by predisposing to the development of important diseases like diabetes, hypertension, atherosclerosis, heart diseases, arthritis, infertility etc and diminishes the efficacy and happiness of affected. As per Ayurveda, Acharya charaka has counted Sthoulya under the eight varieties of impediments which are designated as Ninditapurusha. As Chikitsa sutra of Sthoulya, Lekhan karma is an important therapeutic measure said by Acharya charaka. Moreover, drugs of Arogya vardhini vati and Lekhaniya mahakashaya are most effective in the management of Sthoulya. To assess the effect of Lekhan karma, 20 patients were selected for this study from the OPD and IPD of Uttarakhand Ayurved University, Gurukul Campus Hospital, Haridwar. The effect of the therapy was assessed statically based on the performa prepared. INTRODUCTION Acharya charaka has counted sthoulya under the eight varieties of impediments which are designated as Ninditapurusha. [1] Obesity is a state in which there is abnormally great amount of neutral fat in the storage depots of the body. It tends to develop in both men and women at middle age, and in women it frequently begins after childbirth. [2] Obesity is defined as body weight above a desirable standard as a result of lack of physical activities with increased intake of food. A BMI of 25 to 29.9 kg per m 2 is defined as overweight. [3] A BMI of 30 kg per m 2 or more is defined as obesity. The excessive accumulation of fat in the subcutaneous and deep tissues, is due to excessive intake as compared with output of calories. [4] Although no satisfactory etiological classification of obesity is well defined but number of factors are known to be associated with its development. Obesity is most prevalent in middle age, but it can occur at any stage of life. It is prevalent in high socio-economic group. Familial tendency exist in many cases. Endocrine factors and imbalance are also responsible for the obesity. [5] Obesity is not a new problem it is also described in Ayurvedic literature as well. Causative factors of obesity are lack of exercise, sleeping day time (Diwa swapa), excessive eating of Madhura (sweet), Snigdha (oily), Sheeta (cold) food, Bijadosha (genetic causes). [6] Due to these factors fat metabolism of human body get disturbed i.e. Medo Dhatwagni mandya, leads to excessive deposition of fat in body leads to obesity. In the past few years there has been a dramatic increase in AYUSHDHARA July - August 2018 Vol 5 Issue 4 1781

obesity and obesity related health hazards. At present in India about 30 million Indians are obese. It is predicted to double in the next 5 years. Easy access to high-calorie packaged foods, consumption of more calories than one can burn out by exercise, lack of exercise, sedentary lifestyles have resulted in almost 70% Indians in megacities such as Mumbai, Delhi, Bangalore or Chennai being overweight or obese. [7] Obese individuals are at increased risk of morbidity/ mortality from type 2 diabetes, hypertension, coronary artery disease (CAD), cancer (particularly colon, prostate, and breast cancer), sleep apnoea, degenerative joint disease, thromboembolic disorders, and dermatologic disorders. [8] In modern medicine pharmacological treatment for obesity have side effects [9,10] like drug interfere with the absorption of fat soluble vitamins like A,D,E,K. Liposuction, bariatric surgery are other treatment measures, which have many side effects and are expensive. [10] Clinically Ayurvedic medicines are found to be useful in weight reduction. Arogya vardhini vati and Lekhaniya mahakashaya [11] consist of properties of reduction of fat without interfering digestion and absorption of vitamins. Aims and Objective The aim of study was to assess the effect of Arogyavardhini vati and Lekhaniya mahahkashaya in the management of Sthoulya. Study Design Total 20 patients were enrolled in this trial. Arogyavardhini vati and Lekhaniya. Kashaya was given twice a day for 2 months. Clinical assessment of enrolled patients was done at the end of each month. Drug profile The Arogyavardhini vati described in Ras Ratna Samuchyaya contains Suddha parad, Gandhak, Lauha bhasm, Abhraka bhasma, Tamra bhasma, Haritaki, Bhibhitaka, Amalki, Suddha shilajatu, Suddha gugulu, Chitraka moola and Kutki. Lekhaniya mahakashaya is described in Charak Samhita contains 10 drugs namely- Mustak, Kustha, Haridra, Daruharidra, Vacha, Ativisha, Kutki, Chitrak, Chirbilva and Hemvati. [12] Due to unavailability of Hemvati, Shuddh guggulu was taken in place of Hemvati in this trial. Administration of the drug Tablet Arogya vardhini vati 2 tablets of 250 mg twice a day with lukewarm water after meal and Lekhaniya mahakashaya was given in decoction form in the dose of 50 ml BD empty stomach. AYUSHDHARA, 2018;5(4):1781-1785 Inclusion Criteria 1) Men and women of 20 year to 65 year of age. 2) Patients with BMI more than 30. 3) Measurement of waist circumference -Waist circumference >40 inches (>102 cm) in men and >35 inches (>88 cm) in women. 4) Patients who had obesity associated with pain in weight bearing joints. Exclusion Criteria 1) Obesity secondary to hypothyroidism. 2) Patients with hypertension, diabetes mellitus, hyperlipidemia or cushing syndrome. 3) Any concomitant serious disorder of the liver, kidneys, heart, lungs or other organs. 4) Pregnancy and lactation. 5) Person undergoing treatment for any other serious illness. Assessment Criteria In this project enrolled patients were assessed on the basis of pre-observations and post observations. Subjective Criteria Symptoms were taken in to consideration for the assessment of results. Following symptoms were observed before treatment followed by every 15 days and after completion of trial. 1. Ashkti 2. Kshudhra Shwasa 3. Trishna 4. Atinidra 5. Anga Sethilya 6. Swedadhikya 7. Alap Pranshakti 8. Udar Vridhi 9. Utsaha Hani 10. Bubuksha Vridhi 11. Vikrit Sharer Ghatan 12. Sharir Bhar Vridhi The symptoms were assessed before and after the treatment by using the grade: Grade 0 Normal, Grade 1 Mild, Grade 2 Moderate & Grade 3 Severe. Objective Criteria BMI (Body mass index) Body weight Waist circumference Waist to Hip ratio The patient was assessed before and after the treatment on above parameters. AYUSHDHARA July - August 2018 Vol 5 Issue 4 1782

V. B. Kumawat et al. Trial of Arogya Vardhini Vati Andlekhaniya Mahakashaya in the Management of Obesity Selection of Patients For the clinical study 20 clinically diagnosed cases of obesity were selected from OPD of Department of Panchakarma, Gurukul Campus Hospital, UAU, Haridwar. For the subjective assessment of result symptoms were observed before the treatment and after the treatment. Observation Details history & clinical examination of cases was done in every 15 days in 60 days of trial. Duration of Trial Clinical trial was done for 60 days. In both group patients were advised for light physical exercise like walking, diet restriction like avoidance of excess oily, spicy food & excess sweets. Table 1: The distribution of patients according to age Age Group No. of Patients Percentage (%) 21 30 years 6 30 31-40 years 9 45 41-50 years 3 15 51-65 years 2 10 Table 2: This distribution of patients according to sex Sex No. of Patients Percentage (%) Male 06 30 Female 14 70 Table 3: The distribution of patients according to socio- economic status Income status No. of Patients Percentage (%) Upper class 2 10 50 Middle class 6 30 Lower middle 4 20 Table 4: The distribution of patients according to Prakruti Dehaprakruti No. of Patients Percentage (%) Kaphaj 16 80 Pittaj 3 15 Vataj 1 5 Table 5: The distribution of patients according to Koshtha Koshtha No. of Patients Percentage (%) Mradu 4 20 Madhyam 6 30 Krura 10 50 Table 6: The distribution of patients according to dietary habit Diet No. of Patients Percentage (%) Veg. 13 65 Non-Veg and Veg 7 35 AYUSHDHARA July - August 2018 Vol 5 Issue 4 1783

RESULT AYUSHDHARA, 2018;5(4):1781-1785 Table 7: The percentage of relief in symptoms wise observation Sr. No. Parameter N Score Mean % of Relief BT AT BT AT 1 Ashkti 16 26 18 1.62 1.12 69.13 2 Kshudra shwasa 14 24 18 1.71 1.28 74.85 3 Trishna 10 20 14 2.0 1.4 70 4 Atinidra 16 28 20 1.75 1.25 71.42 5 Anga sethilya 12 24 16 2.0 1.33 66.5 6 Swedadhikya 14 26 20 1.85 1.42 76.75 7 Alap pranshakti 12 30 20 2.5 1.66 66.4 8 Udarvridhi 20 40 24 2.0 1.2 60 9 Utsaha hani 20 40 24 2.0 1.2 60 10 Bubuksha vridhi 15 30 22 2.0 1.46 73 11 Vikrit sharir ghatan 20 32 22 1.6 1.1 68.75 12 Sharir bhar vridhi 20 40 24 2.0 1.2 60 13 BMI 20 36 24 1.8 1.2 66.6 Table 8: The effect on weight, BMI and waist circumference Mean SD SE T value Remark Weight 3.1 1.56 0.49 10.5 Significant 5% level of significance (p<0.05) BMI 1.63 0.61 0.20 10.68 Significant 5% level of significance (p<0.05) Waist circumference 1.32 0.65 0.23 6.43 Significant 5% level of significance (p<0.05) DISCUSSION Total 20 patients (14 females and 6 males) were enrolled in the project. All male patients had hip waist ratio more than 0.90. Out of 14 enrolled females, 10 females had hip waist ratio more than 0.80 and 4 females had hip waist ratio more than 0.70. Among 20 enrolled patients 12 patients had BMI between 30.0 to 34.9 kg/m 2, 6 patients had BMI between 35.0 to 39.9m 2 and 1 patient had BMI between >40 kg/m 2. The results obtained by the study show a significant relief in almost all the associated symptoms of obesity. The maximum effect was observed in Kshudra swasha (74.85%) and Swedaadhikya (76.75%). The objective parameters show significant effect of treatment. The changes observed in BMI, body weight and waist circumference are encouraging. The formulation Arogyavardhini vati contains Tikta-katu ras predominance, Laghu ruksha and Sukshma guna and Ushna veerya. That s why it has Deepan, Pachana, Shrotosodhana and Lekhana properties. It corrects all three Agni specially Dhatwagni mandhyta and reduces the Ama and Abadha meda dhatu deposition. The properties of Lekhaniya mahakashaya are Katu, Tikta, Ras and having Laghu, Ruksha, Tikshana, Lekhan guna, Katu vipak and Ushana veerya, Kaphavatashamak. By this Lekhan and Medohara action, the quantity of Abadha meda reduced from the dependable parts of the body, which brought Laghuta, and relief in Chalatva. Though the Udipta jatharagni get pacified, so Ksudha adhikya diminished. Sweda is the mala of the Meda, so reduction of the Meda inhibits excess sweating. Due to Deepan pachan properties of Lekhaniya mahakashaya, nutrients get digested and Dhatu poshakansha can easily reach to respective Dhatus enhancing the proper nutrition to all Dhatus. CONCLUSION The combination of Arogyavardhini Vati and Lekhneeya Mahakashaya is an effective treatment of obesity. Both of drugs contain the properties of Lekhana, Pachana and Shodhana which are very helpful in reducing the deposited fat of the body. REFERENCES 1. Charak Samhita based on Chakrapani Datta s Ayurveda Dipika, Author name Dr. Ram Karam Sharma and Vaidya Bhagwan Dash, Reprint AYUSHDHARA July - August 2018 Vol 5 Issue 4 1784

V. B. Kumawat et al. Trial of Arogya Vardhini Vati Andlekhaniya Mahakashaya in the Management of Obesity Chapter 21-Astauniditiyayhyaya, Shloka number 3, pp. 375. 2. Sir Ronald Bodley Scott, Textbook of the practice of medicine, 12 th edition, Oxford University Press 1978, pp. 432-434. 3. E.C. Waener, Savill s System of Clinical Medicine, 14 th edition, England, Edward Arnold (Publisher) Ltd.1964, pp. 26-28. 4. E.C. Waener, Savill s System of Clinical Medicine, 14 th edition, England, Edward Arnold (Publisher) Ltd.1964, pp. 26-28. 5. Sir Ronald Bodley Scott, Textbook of the practice of medicine, 12 th edition, Oxford University Press 1978, pp. 432-434. 6. Charak Samhita based on Chakrapani Datta s Ayurveda Dipika, Author name Dr. Ram-Karam Sharma and Vaidya Bhagwan Dash, Reprint Sanskrita Series, Volume I, Charak- Vimansthan Chapter 5 Srotoviman, Shloka number 15, pp. 178. 7. Madhav Nidan by Vijayaraksita and Shrikanthadatta and extracts from Atankadarpana by Vachaspati Vaidya, Edited by Vaidya Yadavji Tricumji Acharya, Reprint edition 2010, Delhi, Publisher Chaukhamba Orientalia, Chapter 34 Medoroga Nidanam, shloka no 1,2, pp. 226, 8. Ferries Clinical Adviser Instant Diagnosis and Treatment, 2009 edition, Author Fred F. Ferri - Printed in United States of America, ISBN No- 978-0-323-04134-8, e-library copy, Website - www.mdconsult.com., Section-I Disease and Disorders, Chapter name Obesity. 9. ACP Medicine (American college of Physicians Medicine) by David C. Dale and Daniel D. Federman, 3rd edition 2007, Section III-Chapter no. 10. 10. Dr.Shashank Joshi, API Textbook of medicine 7th edition, of India, Section VIII-Metabolism Chapter 06 Disorders of Adipose tissue and Obesity chapter, pp. 264. 11. Charak Samhita based on Chakrapani Datta s Ayurveda Dipika, Author name Dr.Ram Karam Sharma and Vaidya Bhagwan- Dash, Reprint Chapter 4 Sadvirechanasatasritiyadhya, Shloka number 8, pp. 88. 12. Charak Samhita based on Chakrapani Datta s Ayurveda Dipika, Author name Dr.Ram Karam Sharma and Vaidya Bhagwan- Dash, Reprint Chapter 4 Sadvirechanasatasritiyadhya, Shloka number 8, pp. 88. Cite this article as: V. B. Kumawat, Bhanupriya Kaushik, Rashmi, Abhishek Saxena, Uttam Kumar Sharma. A Clinical Trial of Arogya Vardhini Vati Andlekhaniya Mahakashaya in the Management of Obesity. AYUSHDHARA, 2018;5(4):1781-1785. Source of support: Nil, Conflict of interest: None Declared Disclaimer: AYUSHDHARA is solely owned by Mahadev Publications - A non-profit publications, dedicated to publish quality research, while every effort has been taken to verify the accuracy of the content published in our Journal. AYUSHDHARA cannot accept any responsibility or liability for the articles content which are published. The views expressed in articles by our contributing authors are not necessarily those of AYUSHDHARA editor or editorial board members. AYUSHDHARA July - August 2018 Vol 5 Issue 4 1785