Research article Clinical Evaluation of Tab. Lipodieresis and Phalatrikadi Lekhana Basti (Both Kalpita Yoga) in the Management of Sthaulya (Obesity)

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1 Research article Clinical Evaluation of Tab. Lipodieresis and Phalatrikadi Lekhana Basti (Both Kalpita Yoga) in the Management of Sthaulya (Obesity) Dr.Seetha Madhavi, Assistant Professor, Department of Panchakarma, MSM Institute of Ayurveda, BPS Mahila Vishvavidyalaya, Khanpur Kalan, Sonipat, Haryana Received 1 Mar 2014; Accepted 18 Mar 2014 Corresponding Author*: seethamadhavi85@yahoo.com ABSTRACT Sthaulya (Obesity) is a social, psychological and somatic disorder leading to miserable life and a challenge to the physician in treatment since it exacerbates a large number of healthrelated problems, independently and as an involvement with other diseases. The etiological factors mainly vitiate the Meda-Kapha and this vitiated Meda obstruct the path of Vata, which results in to provocation of Vata. In the pathogenesis of obesity two factors are of prime significance, Tikshna Jatharagni (Intense metabolism) and Medodhatvagni-mandya (Reduced fat metabolism). Irrationality between two levels of Agni makes the disease Krichha Sadhya (Difficult to treat), but Shodhana (Purification) and Shamana (Palliative) therapy can give better solution for this problem. In the present study, Phaltrikadi Lekhana Basti and Tab. Lipodieresis compound were selected for the management of Sthaulya and the study was carried out at Hospital, National Institute of Ayurveda, Jaipur to evaluate effect of Tab. Lipodieresis compound and Phaltrikadi Lekhana Basti in the management of Sthaulya. The duration of the treatment in all the groups was one month with follow-up for one month. The data composed during the study were analyzed statistically. Key-words: Sthaulya, Obesity, Lekhana basti, B.M.I. How to Cite this Article Dr.Seetha Madhavi; Clinical Evaluation of Tab.Lipodeiresis and Phalatrikadi lekhana Basti (Both Kalpita yoga) in the management of Sthoulya. Soushrutam Int.Res.J. Of Phar. & Plant sci., Vol 2(2), 2014:

2 INTRODUCTION Sthaulya (Obesity) is included under eight undesirable conditions (Ashtau Nindita, Shleshma Nanatmaja, Samtarpana (diseases due to excessive nutrition s) Nimittaja, Ati Brihmana Nimittaja and Bahu Dosha Janita Vikara.) (Shastri, K. Nath; Chaturvedi, GN 1989) furthermore Sushruta has emphasized on Dhatvaagnimandya (Metabolic disturbances) in the Samprapti vighatana (Aetiopathogenesis) of Sthaulya in his treatise Sushrutha samhita. The patients of Sthaulya exhibits very eccentric phenomenon. Their appetite is excessive and whatsoever they eat is rapidly digested, which indicates hyper functioning of the Jatharagni (Digestive fire). (Shastri, K. Nath; Chaturvedi, GN 1989). Beside this, patients suffer from Alasya (laziness) may be due to less supply of energy, which may be due to hypo functioning of Bhootagni. Further Dhatvaagni also seems to be disturbed, because in Sthaulya patient mainly Medo- Dhatu is formed and there is deficiency of other dhatus. (Shastri, K. Nath; Chaturvedi GN 1989). Hence, it can be inferred that in Sthaulya; Jatharagni is Tikshna, Bhootaagni is Manda (Poor) and Dhatvaagni is concerned in their respective functions. On the basis of the above mentioned facts of pathogenesis of Sthaulya, it can be said that the drug, which decreases Jatharaagni particularly Abhyavaharana Shakti, increases Bhutaagni and corrects the functions of Dhatvaagni and at the same time have Shlesma- Medohara (which removes or dries up excess Medas and Sleshma ) and Vata-Shamaka, actions, may be suitable for its management (Shastri, Lalchandra Vaidya 1981). Taking all the above mentioned facts in consideration, we have chosen some drugs of Lekhaniya Mahakashaya along with other drugs which are suggested by different ancient scholars in their treatises (Shastri Ambikadutt 2012) for the treatment of Obesity and added some more drugs which also have Deepana (Appetisers), Pachana (Digestives), Chedana, Kaphavata Shamaka and Lekhana (which scrapes excess Medas) properties, and existing an herbal formulation [Kalpita Yoga] Tab. Lipordireasis and Phalatrikadi Lekhana Basti (Rukshoshna bastayasthikshna) (Shastri, K. Nath; Chaturvedi, GN 1989) for the present study. Tab.Lipodireasis has been administered with Honey as an adjuvant (Shastri, K. Nath; Chaturvedi GN 1989). The majority of these drugs of 136

3 Tab. Lipordireasis and Phalatrikadi Lekhana Basti are Lekhana, Medohara, Deepana, Pachana, Srotoshodhaka, Amapachana, Shoshana and Kapha- Vatahara indicated in the treatment of Sthaulya in Ayurvedic classics. MATERIALS AND METHODS A. Aims and objectives 1. To highlight the original approach of Ayurvedic system of medicine in understanding the Samprapti (Aetiopathogenesis) of Sthaulya Roga with modern background. 2. Clinical evaluation of Tab. Lipodieresis and Phaltrikadi Lekhana Basti on the basis of various scientific parameters in certain obese patients. B. Selection of the patients Patient reporting in the O.P.D/I.P.D. Dept. of Panchakarma, National Institute of Ayurveda Hospital. Jaipur has been selected based on classical reference of obesity irrespective of age, sex, religion, caste etc. C. Criteria of diagnosis The diagnosis was mainly based on the clinical presentation as mentioned in the Ayurveda texts as well as medicine texts along with Body mass index (BMI). A detail Performa incorporating all the clinical aspects mentioned for Obesity was prepared accordingly, detailed clinical history was taken and physical examination was done. D. Criteria for selection of patients Patients in the age group of years were selected for the present study. Other criterion for inclusion was as followed: E. Subjective Criteria Patients having clinical presentation of Sthaulya (obesity) as mentioned in the Ayurvedic texts as well as medicine texts. F. Objective Criteria For the present study BMI more than 30 was taken for considering the patients having BMI were included for the present study. BMI calculated on the basis of height and weight of each patient. Standard range of normal body weight in relation to height mentioned by Life Insurance Corporation of India was adopted. An international criterion for BMI was used to calculate the BMI by the following formula: BMI= Weight (in kg)/ Height (in meter) G. Exclusion Criteria Patients in the age group of less than 20 years and more than 50 years were not included for the present study. Obese patient suffering from hypothyroidism, obesity due to hormonal imbalance, cardiovascular diseases, hemiplegic, associated with severe hypertension and 137

4 from other such diseases in which the patients can t do his routine physical activities were excluded. Very obese patients having BMI more than 45 were excluded from the present study. H. Investigations Lipid profile was carried out approximately in all the patients before and after the study and Fasting blood sugar was carried out in suspected cases only. I. Other examination and tests Weight was recorded before starting the treatment and later on every week of the study. Weight was also recorded of all the J. Scoring criteria of Subjective parameter: patients who have come for the follow-up study. Circumferences of fatty parts were recorded before and after every week, till the completion of the course of treatment, to assess the effect of therapy. The effectiveness of therapy on body fat was assisted by measuring the skin fold thickness by Vernier calipers before and after the treatment in particular area of middle portion of the biceps and triceps muscles, middle portion of the supra-iliac region and the anterior surface of midthigh region and of abdominal muscle at umbilicus. Table No.1 Daurbalya (Decrease of Strength) 0 Can do routine exercise 1 Can do exercise without difficulty 2 Can do only mild exercise 3 Can do mild exercise with difficulty 4 Cannot do even mild exercise 138

5 Table No.2 Daurgandhata (Bad Odor) 0 Absence of bad smell 1 Occasional bad smell in the body removed after bathing 2 Persistent bad smell limited to close area difficult to suppress with deodorant 3 Persistent bad smell felt from long distance is not suppressed by deodorant 4 Persistent bad smell felt from long distance even intolerable to pt. Table No.3 Swedabadha (Excess Perspiration) 0 Sweating after heavy work & fast movement/in hot season 1 Profuse sweating after moderate work and movement 2 Sweating after little work and movement 3 Profuse sweating after little work and movement 4 Sweating even at rest or in cold season Table No.4 Kshudatimatram (Excessive Hunger) 0 Taking diet 3 times a day without any supplementary diet 1 Taking diet 3 times a day with any supplementary diet 2 Taking diet 2-5 times a day without any supplementary diet 3 Taking diet 2-5 times a day with any supplementary diet 4 Taking irregular for intermittent diet 139

6 Table No.5 Pipasatiyoga (Excessive Thirst) 0 Normal thirst 1 Up to one liter intake of water 2 Up to 1-2 liter intake of water 3 Up to 2-3 liter intake of water 4 More than 3 liter intake of water Table No.6 Javoparodha (Decrease in enthusiasm and activity) 0 Person go for walk daily 1 Person go for walk but unwillingly 2 Person go for walk with difficulty 3 Person go for walk alternately 4 Person thinks for walk but can't go for walk. Table No.7 Chalsphickudarastana (Flabbiness of Hips, Abdomen and Breast) 0 Absence of Flabbiness of Hips, Abdomen and Brest 1 Little visible movement after fast movement 2 Little visible movement even after moderate movement 3 Movement after mild movement 4 Movement even after changing posture 140

7 Table No.8 Kshudraswasa (Dyspnoea) 0 Dyspnoea after heavy work but relieved soon & up to tolerance 1 Dyspnoea after moderate work but relieved later & up to tolerance 2 Dyspnoea after little work but relieved later & up to tolerance 3 Dyspnoea after little work but relieved later & beyond tolerance 4 Dyspnoea at resting condition (no work condition) Table No.9 Nidradhikya (Excessive Sleep) 0 Normal sleep 6-7 hrs/day 1 Sleep up to 8 hrs/day with Angagaurava 2 Sleep up to 8 hrs/day with Angagaurava and Jrimbha 3 Sleep up to 10 hrs/day with Tandra 4 More than 10 hrs/day Table No.10 Gaurava (Heaviness) 0 No heaviness in the body 1 Occasional heaviness but does usual work 2 Continuous heaviness but does usual work 3 Continuous heaviness which hampers usual work 4 Unable to do any work due to heaviness 141

8 Table No.11 Anutsaha (Sedentary lifestyle) 0 No Alasya (doing work satisfactorily with proper vigor in time) 1 Doing work satisfactorily with late initiation 2 Doing work unsatisfactorily under mental pressure and takes time 3 Not starting any work himself and doing little work slowly 4 Does not take any initiation and don't want to work even after pressure Table No.12 Ayathopachaya (Excessive accumulation of adipose tissue) 0 No accumulation of adipose tissue 1 Partial/mild accumulation of adipose tissue 2 Moderate accumulation of adipose tissue 3 Profuse accumulation of adipose tissue 4 Extensive accumulation of adipose tissue K. Grouping of patients Thirty six patients of Sthaulya were registered for this study and were divided into three groups viz Table No.13 Distribution of 36 patients of Sthaulya in all groups Patients No. of Patients Total Group-A Group-B Group-C Completed LAMA Total

9 Leave against medical advice L. Statistical Analysis Effect of therapy was assessed after accomplishment of the treatment. All the observations, parameters were subjected to statistical analysis in term of Mean, Standard deviation (SD), Standard error (SE), Paired t-test was carried out at p-values. The obtained result were interpreted as following Insignificant - > 0.05 Significant - < 0.05, <0.02, <0.01 Highly significant - <0.001 M. Administration of drugs 1. First group was given Shamana Chikitsa (Palliative) in the form of Tab. Lipodieresis 2 gms three times a day with lukewarm water before meal for a period of one month along with Madhoodaka. (Shastri, K. Nath; Chaturvedi, GN 1989) 2. Second group was given only Shodhana (Purification) Chikitsa in the form of Phaltrikadi Lekhana Basti (Medicated enema Kalpita Yoga) in the morning for one month. Basti Chikitsa was given for 30 days according to the Karma Basti regimen (Shastri, K. Nath; Chaturvedi, GN 1989). The Purva karma (Preparatory methods), Pradhan karma (Main methods) and Paschat karma (Post operative measures) were carried out according to the textual description (Kasture H. S. 2003). 3. Third group was treated with both Shamana (Palliative) and Shodhana (Purification) Chikitsa simultaneously. Diet related restrictions and advice based on Ayurvedic classics was followed in all groups. N. Method of preparation of drug Tab. Lipodieresis compound comprises of twenty one drugs namely Triphala (Haritaki, Amalaki, Vibhitaka), Kushtha, Nagarmotha, Vacha, Ativisha, Kutki, Chirbilva, Guduchi, Katphala, Vidang, Shunthi, Patolpatra, Bilivapatra, Haridra, Daruharidra, Marich, Nimbatwak and Guggulu. Firstly the fine powder of all the drugs was taken in equal quantity. Mixture of all powders was given seven Bhavanas (Trituration) of Kulatthaq qwatha and at 143

10 the end Gomutra Kshara and Guggulu was added to it. O. Duration of treatment Duration of treatment for all the groups was one month. P. Criteria of assessment After completion of one-month duration treatment, the effect of therapy was assessed on the basis of following subjective as well as objective criterion. Q. Subjective criteria A multidimensional scoring pattern was adopted for the sign and symptoms of Sthaulya mentioned in Ayurvedic text. The score of symptoms was assessed before and after the treatment and statistical analysis was undertaken. Apart from cardinal sign and symptom other sign and symptoms were also assessed. This assessment was done before starting the treatment and thereafter 15 days till completion of therapy. The paired t test was applied for the statistical analysis of the results. Moreover assessment of Dhatu, Dushya, Srotasa based on their dominant symptoms was also carried out. Table No.14 Comparison of the effects of therapies on Subjective parameters of 30 patients of Sthaulya Subjective Parameters Group A Group B Group C % of Relief P % of Relief P % of Relief P < <0.001 Daurbalyata < 0.02 Daurgandha 40 > > < 0.05 Swedabadha < < <0.001 Kshudatimatra < < <0.01 Pipasatiyoga 30 < < <0.01 Javaparodha < < <0.01 Chalsphikaudar < <0.01 Stana <0.001 Kshudra swasa < < <0.001 Nindradhikya 37.5 < < <0.001 Gaurav < < <0.001 Anutsaha < < <0.01 Ayathopachaya 37.5 < < <

11 Table No. 15: Comparison of the effects of therapies on Objective parameters of 30 patients of Sthaulya Objective Parameters Group A Group B Group C % of Relief P %of Relief P %of Relief P Haemoglobin 8.83 < < >0.05 Blood Sugar 1.13 > > >0.05 HDL 16.6 < < > > < >0.05 LDL Triglyceride 2.88 > > >0.05 S. Cholesterol 2.51 > < >0.05 BMI 3.83 < < <0.001 Weight 3.84 < < <0.001 Hip circum < < <0.001 Mid thigh circum < < <0.001 Mid arm circum < < <0.001 Waist circum < < <0.001 DISCUSSION All the patients tolerated medicines very well and no side effects or toxicity effects of any of these drugs were reported by any of the patients selected in current series of 30 patients of Sthaulya Roga (Obesity), suggesting there by that the drugs selected for the current clinical trial are absolutely safe for internal use by the patients. It is not worthy here that the average reduction in body weight & BMI in Tab.Lipodieresis treated group was 3.84% & 3.83%, in Phaltrikadi Lekhana Basti group it was 4.26% & 4.37%. And in mixed group where Tab.Lipodieresis and Phaltrikadi Lekhana Basti was simultaneously used, it was 6.10% and 6.15%. Therapy has dominant results in Daurbalyatā, Swedabadha, Gaurava, Pipasatiyoga and C.S.U.S. Therapy also has mental effect so that patient feels activeness and alertness in daily routine. Therapy s major effect is over Anutsaha. Therapy has reduced LDL, Blood sugar, Triglycerides and Serum Cholesterol and enhancement in HDL and Hemoglobin. 145

12 All three Groups show highly significances in Waist, Hip, Mid thigh measurement, BMI and weight CONCLUSION The treatment modality was planned considering the pathological conditions mentioned in the classical texts. Among the two trial groups Basti (Enema) provided better result in almost all the parameters because it eliminates Doshas (Humours) from the body and simultaneously absorbed the drug and execute their action of Samprapti Vighatana (Aetiopathogenesis) at cellular level. It can be concluded that Tab.Lipodieresis and Phalatrikadi Lekhana Basti has potent effect on various clinical parameters. But when Tab.Lipodieresis and Phalatrikadi Lekhana Basti was administered together they have produced highly significant improvement in objective as well as subjective parameters. Earlier mentioned observations were suggested of the fact that Shamana therapy (Palliative) in the form of administration of Tab. Lipodieresis had shown significant subjective and objective improvement while the administration of Phalatrikadi Lekhana Basti i.e. Shodhana therapy (Purification) has produced comparatively better results than group (A) in subjective and objective parameters. The clinical response is further enhanced to the level of highly significant level when Shamana therapy [Tab.Lipodieresis] and Shodhana therapy [Phalatrikadi Lekhana Basti] were administered collectively. Basti is a purification mechanism in which vitiated doshas, malas and toxins are expelled out from the rectal canal and thus complete cleansing effect is produced and Vatika functions are properly regulated in the body (Shastri K, Chaturvedi G.N 1989) which helps in providing long lasting beneficial effects in the patients of Sthaulya. Acknowledement I am Thankful to Prof. M.C.Sharma Director, National Institute of Ayurveda, Jaipur and Prof. R. S Sharma, Head P.G Department of Panchakama and superintendent of the Hospital of National Institute of Ayurveda Jaipur for their guidance and other facilities provided for this study. I owe my thanks to Dr. O.P. Sharma, Guide of this research work, hospital staff, laboratory staff, library staff of National Institute of Ayurveda and patients for their sincere support in this clinical trial. I am thankful to Dr. Hemant Kumar seetha, (AMO) Govt. of Rajasthan for his helpful criticism and discussion in preparing this paper. 146

13 REFERENCES Kasture H. S. (2003), Ayurvediya Panchakarma Vigyana: 7th edition, Shri Vaidyanath Ayurveda Bhawan Limited. pp.172. Shastri K Nath, Chaturvedi GN (1989) Charaka Samhita, Vidyotini Hindi Commentary, Varanasi: Chaukhambha Bharati Academy, pp.407,411,415. Shastri, Shambhunath (1952) Sushruta Samhita, Subodhini Hindi Commentary, Sutrasthana, Dosha Dhatu Mala Kshaya Vriddhi Vijaniyam Adhaya 15/35, 1 st edition, Shri Saraswati Pustakalaya, Chauk, Kanpur; pp. 45. Shastri Ambikadutta (2012) Sushruta Samhita, Ayurveda Tatva Sadipika Hindi Commentary, Chikitsa Sthan 38/82, Reprint edition, Chaukhambha Sanskrit Sansthan,Varanasi; pp.214 Shastri Lalchandra Vaidya (1981) Vagbhata, Ashtanga Sangraha Sarvangasundari Hindi Commentary, Sutrasthana 1/24/15, nd edition,vaidyanath Ayurveda Bhavan Limited; Nagpur; pp. 692, 695. Sharma P.V (1990) Dravyaguna Vigyana, Vol.11 Varanasi: Chaukhambha Bharati Academy; pp.30,55, 356,371,443,572,817. Source of Support: Nil Conflict of Interest: None declared 147