a comparative study of lekhan therapy in the management of sthoulya

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Nayak Annada Prasad / IJRAP 3(4), Jul – Aug 2012 508 Research Article www.ijrap.net A COMPARATIVE STUDY OF LEKHAN THERAPY IN THE MANAGEMENT OF STHOULYA (OBESITY) Nayak Annada Prasad* Dept. of Kayachikitsa, MSM Institute of Ayurved, BPS Women University, Sonipat, Haryana, India Received on: 08/05/12 Revised on: 23/06/12 Accepted on: 02/07/12 *Corresponding author Dr A.P Nayak, Lecturer, MSM institute of Ayurved, Khanpur kalan, Sonepat, Harayana, India Email: [email protected] ABSTRACT Obesity is the world’s oldest metabolic disorder. The WHO now considers obesity to be a Global epidemic and a public health problem. Globally an estimated 300 million adults are now obese and many are overweight. Prominent health risks associated with obesity are hypertension, type-2 diabetes mellitus, dyslipidemia, stroke, gall bladder stone, osteoarthritis, respiratory problem etc. As per Ayurveda, Acharya Charak has counted Sthoulya under the eight varieties of impediments which are designated as Nindita Purusha. According to Chikitsa Sutra of this disease, Lekhan therapy is an important therapeutic measure in Sthoulya as said by Acharya Charka. Moreover lekhan basti is the other and most effective therapy in the management of Sthoulya. To assess the effect of lekhan therapy by two therapeutic modules, 24 Sthoulya patients were selected for this study and were divided into two groups. Group A patients were given 15 lekhan basti in alternate day. After completion of basti, lekhan vati was given for two months. In group B, patients were given lekhan vati for three months, which was selected from Ca.Su.4:9 as lekhaneeya dasemani and is added with Varun and Vidang. The effects of two therapeutic modules were assessed statistically based on the Performa prepared. This was a humble effort to compare the effect of lekhan basti and lekhan vati in the management of Sthoulya. In this study we have found that lekhan basti followed by lekhan vati was more effective in combating the disease than only lekhan vati therapy. Keywords: Sthoulya, Lekhan Basti (L.B.), Lekhan Vati (L.V.), Lekhan therapy, Obesity INTRODUCTION Obesity is defined as body weight above a desirable standard, as a result of lack of physical activity with increased intake of food. Issue of weight and health as we can say, are more complex than simply consuming fewer calories or switching from butter to margarine. Obesity is well defined in Ayurveda by ancient scholars as Sthoulya and Atisthoulya. In this context Acharya Susruta also mentioned that Madhyam Sarira 1 is best but Ati sthula and Ati krisha are always affected with some diseased conditions. Sthoulya is a notorious disease which disturbs the total metabolic system of the body. Various treatment modalities have been defined for Sthoulya in our Sahmitas. Among them langhan, swedan, lekhan, guru- apatarpan 2 , Kaphaghna karma and Vaman, Virechana, Basti karma has more importance. Charak has recommended ushma-tikshna basti, where as Sushruta has indicated lekhan basti for Sthoulya. Many Research scholars of Indian medicine have been submitted their thesis on various aspects of this disease. About twenty thesis have been submitted on Guggulu and four thesis on lekhan basti. For the treatment of Sthoulya Charak has recommended lekhaneeya mohakashaya 3 , where as Susruta has mentioned lekhan basti 4 with exact composition. For Lekhan purpose we had added Varun 5 and Vidang 6 with lekhaneeya gana and prepared lekhan ghanavati, which was given in group B. All the drugs (12) of lekhan ghanavati was also used as kwatha dravya in lekhan basti along with all the additives as mentioned by Susruta, which was given in group A. So here we made an endeavor to know the effect of lekhan basti and lekhan vati in the management of Sthoulya by two therapeutic modules. So here we were interested to establish a safe and complete solution for this problem, with the help of Ayurvedic formulation and panchakarma, especially lekhan therapy. Aim and objectives · To study the proper etiopathogenesis of Sthoulya according to Ayurveda and Modern medicine. · To assess the effect of lekhaneeya gana (Kinchit Parivartit) in the form of ghanavati and lekhan basti in the management of Sthoulya. · To compare the effect of lekhan therapy by two therapeutic modules i.e. lekhan basti followed by lekhan vati and only lekhan vati. MATERIALS AND METHODS Source of Drug All the raw drugs (12) for kwatha, Tila Taila, Madhu, Saindhava, Yavakshara and Lekhan Ghanavati was provided by Dang Gilla Pharmacy, Ahmadabad, Govt. of Gujarat. Only the Gomutra was collected daily from nearby Gosala. Identification Parameter All the drugs are identified as per classical description in Charak sahmita as well in Bhavaprakash by the Drug analysis officer of the Dang Gilla Pharmacy which were also authenticated by the Dept. of Pharmacognocy, IPGT and RA Jamnagar, India. Source of Formulation The prepared medicines used for the patients selected for the clinical trial, those who were attended the OPD and IPD of Govt. Akhandanand Ayurvedic College and Hospital, as well as from Maniben hospital, Ahmadabad, India. Source of Data The ethical clearance No. is PGT/Ethics / 2001- 2002/5/Agenda no. 26/27.8.2002

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Page 1: a comparative study of lekhan therapy in the management of sthoulya

Nayak Annada Prasad / IJRAP 3(4), Jul – Aug 2012

508

Research Article www.ijrap.net

A COMPARATIVE STUDY OF LEKHAN THERAPY IN THE MANAGEMENT OF STHOULYA (OBESITY) Nayak Annada Prasad* Dept. of Kayachikitsa, MSM Institute of Ayurved, BPS Women University, Sonipat, Haryana, India Received on: 08/05/12 Revised on: 23/06/12 Accepted on: 02/07/12 *Corresponding author Dr A.P Nayak, Lecturer, MSM institute of Ayurved, Khanpur kalan, Sonepat, Harayana, India Email: [email protected] ABSTRACT Obesity is the world’s oldest metabolic disorder. The WHO now considers obesity to be a Global epidemic and a public health problem. Globally an estimated 300 million adults are now obese and many are overweight. Prominent health risks associated with obesity are hypertension, type-2 diabetes mellitus, dyslipidemia, stroke, gall bladder stone, osteoarthritis, respiratory problem etc. As per Ayurveda, Acharya Charak has counted Sthoulya under the eight varieties of impediments which are designated as Nindita Purusha. According to Chikitsa Sutra of this disease, Lekhan therapy is an important therapeutic measure in Sthoulya as said by Acharya Charka. Moreover lekhan basti is the other and most effective therapy in the management of Sthoulya. To assess the effect of lekhan therapy by two therapeutic modules, 24 Sthoulya patients were selected for this study and were divided into two groups. Group A patients were given 15 lekhan basti in alternate day. After completion of basti, lekhan vati was given for two months. In group B, patients were given lekhan vati for three months, which was selected from Ca.Su.4:9 as lekhaneeya dasemani and is added with Varun and Vidang. The effects of two therapeutic modules were assessed statistically based on the Performa prepared. This was a humble effort to compare the effect of lekhan basti and lekhan vati in the management of Sthoulya. In this study we have found that lekhan basti followed by lekhan vati was more effective in combating the disease than only lekhan vati therapy. Keywords: Sthoulya, Lekhan Basti (L.B.), Lekhan Vati (L.V.), Lekhan therapy, Obesity INTRODUCTION Obesity is defined as body weight above a desirable standard, as a result of lack of physical activity with increased intake of food. Issue of weight and health as we can say, are more complex than simply consuming fewer calories or switching from butter to margarine. Obesity is well defined in Ayurveda by ancient scholars as Sthoulya and Atisthoulya. In this context Acharya Susruta also mentioned that Madhyam Sarira1 is best but Ati sthula and Ati krisha are always affected with some diseased conditions. Sthoulya is a notorious disease which disturbs the total metabolic system of the body. Various treatment modalities have been defined for Sthoulya in our Sahmitas. Among them langhan, swedan, lekhan, guru-apatarpan2, Kaphaghna karma and Vaman, Virechana, Basti karma has more importance. Charak has recommended ushma-tikshna basti, where as Sushruta has indicated lekhan basti for Sthoulya. Many Research scholars of Indian medicine have been submitted their thesis on various aspects of this disease. About twenty thesis have been submitted on Guggulu and four thesis on lekhan basti. For the treatment of Sthoulya Charak has recommended lekhaneeya mohakashaya3, where as Susruta has mentioned lekhan basti4 with exact composition. For Lekhan purpose we had added Varun5 and Vidang6 with lekhaneeya gana and prepared lekhan ghanavati, which was given in group B. All the drugs (12) of lekhan ghanavati was also used as kwatha dravya in lekhan basti along with all the additives as mentioned by Susruta, which was given in group A. So here we made an endeavor to know the effect of lekhan basti and lekhan vati in the management of Sthoulya by two therapeutic modules. So here we were interested to establish a safe and complete solution for this problem, with the help of

Ayurvedic formulation and panchakarma, especially lekhan therapy. Aim and objectives · To study the proper etiopathogenesis of Sthoulya

according to Ayurveda and Modern medicine. · To assess the effect of lekhaneeya gana (Kinchit

Parivartit) in the form of ghanavati and lekhan basti in the management of Sthoulya.

· To compare the effect of lekhan therapy by two therapeutic modules i.e. lekhan basti followed by lekhan vati and only lekhan vati.

MATERIALS AND METHODS Source of Drug All the raw drugs (12) for kwatha, Tila Taila, Madhu, Saindhava, Yavakshara and Lekhan Ghanavati was provided by Dang Gilla Pharmacy, Ahmadabad, Govt. of Gujarat. Only the Gomutra was collected daily from nearby Gosala. Identification Parameter All the drugs are identified as per classical description in Charak sahmita as well in Bhavaprakash by the Drug analysis officer of the Dang Gilla Pharmacy which were also authenticated by the Dept. of Pharmacognocy, IPGT and RA Jamnagar, India. Source of Formulation The prepared medicines used for the patients selected for the clinical trial, those who were attended the OPD and IPD of Govt. Akhandanand Ayurvedic College and Hospital, as well as from Maniben hospital, Ahmadabad, India. Source of Data The ethical clearance No. is PGT/Ethics / 2001-2002/5/Agenda no. 26/27.8.2002

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For the clinical part of the present study 24 patients- having disease Sthoulya, were randomly selected from OPD and IPD of Govt. Akhandanand Ayurvedic College and Hospital, as well as from Maniben hospital, Ahmadabad. These 24 patients were divided into two groups. Group A was selected for studying the effect of Lekhan Basti and Lekhan Vati. Group B was selected for studying the effect of Lekhan Vati only. Criteria for diagnosis · Patients were diagnosed on the basis of Performa

prepared with signs and symptoms of Sthoulya in Ayurvedic classics, supported by symptomatology of Obesity.

· Diagnosis of Obesity was undertaken as per LIC / WHO height- weight chart7. A person carrying 10% more weight was selected as Obese.

· Measurement of skin fold thickness8 of Triceps, Biceps muscular region and sub scapular region was carried out by skin fold calipers.

· Body Mass Index (BMI) was calculated. The value of BMI greater than 25 was considered as obese.

Exclusion criteria · Patients with severe hypertension. · Patients with evidence of renal, hepatic and cardiac

involvement. · Patients with Diabetes mellitus. · Patients with hypothyroidism. · Patients with long term steroid treatment.

Management scheme The sample of 30 patients with classical signs and symptoms of Sthoulya were randomly selected. Six patients left the treatment at different stages before completion of the course. (Table 1) Drug profile Formulation of Lekhan Basti (L.B) We Selected Lekhaneeya gana from Ca.Su.4/9 adding with Varun and Vidang for kwath to be used in Lekhan Basti along with other additives as Table 2. Formulation of Lekhan vati (L.V) The combination was processed in Ghanavati form which contains following drugs in equal parts. (Table 3)

Table 1: Management Scheme

Group No. of patients Total no. of patients

Therapy design Dose Duration Course

Completed Course

discontinued A. Lekhan Basti and

Lekhan vati group(LBLV)

12 03 15 15 Lekhan Basti on alternate day +

Lekhan Vati for rest of the days (after completion of Basti)

650 ml/day

20 tabs per day

30days +

60days =90days

B. Lekhan Vati Group(LV)

12 03 15 Lekhan Vati 20 tabs per day 90 days

Table 2: Formulation of Lekhan Basti (L.B)

Sr. No. Additives Quantity Sr. No. Additives Quantity 1 Kwath (of 1-12 drugs as in lekhan vati) 300-400 ml 4 Tila taila 80 ml 2 Gomutra 100ml 5 Saindhav 10gm 3 Madhu 80ml 6 Yavakshara 5gm

Table 3: Formulation of Lekhan Vati (L.V)

Sr. No. Drugs Sr. No. Drugs Sr. No. Drugs 1 Mustha 5 Vacha 9 Karanja 2 Kustha 6 Ativisha 10 Hemavati 3 Haridra 7 Katuki 11 Varuna 4 Daruharidra 8 Chitrak 12 Vidang

Criteria for assessment The results were assessed with regards to improvement recorded, in clinical findings and laboratory investigations. Changes observed in signs and symptoms were assessed by adopting suitable scoring method and objective signs by using appropriate clinical tools. Subjective criteria Score was given according to the severity of symptoms. Absence of symptoms- 0 Mild degree of symptoms- 1 Moderate degree of symptoms- 2 Severe degree of symptoms-3 Severity of symptoms with chronicity - 4 The detail of the score adopted for the main sign and symptoms in present study were as follows:- Chalatava Daurbalya Daurgandhya

Sweda-adhikya Kshudra svasa (dyspnoea on exertion) Pipasatiyoga Nidradhikya Kshudhatimatra Snigdhangata Alasya Objective criteria It was assessed on body weight, measurement of circumference and skin fold thickness, BMI, and biochemical investigation reports, before starting the treatment and after completion of treatment through percentage relief and statistical evaluations. Body weight:- Body weight, 10% more than standard weight according to LIC chart was recruited as obese. Measurement of circumference:-

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For present study the circumference measurement of girth of certain region by using measuring tape, before and after treatment was carried out. Measurement was taken in the following areas as- Chest: - in normal condition at the nipple region. Abdomen:-at the level of umbilicus. Hip:-at the level of highest point of buttock. Mid thigh:-mid of thigh between pelvic and knee joint. Mid arm:- mid arm from shoulders joint to elbow joint In all circumference measurements, the mean values were taken before and after treatment. Skin fold thickness :- The effectiveness of Lekhan therapy was assessed by measuring the skin fold thickness by skin fold thickness calipers before and after treatment in some particular areas like. Skin fold thickness of middle portion of the biceps muscle. Skin fold thickness of the middle portion of the triceps muscles. Skin fold thickness of the middle portion of the sub scapular region. The skin fold measurement was taken bilaterally after exposing mentioned region. BMI (Kg/m2) Investigations Following laboratory investigations were undertaken as Routine and microscopic examination of blood, urine and stool were carried out above tests to exclude other pathogenesis. 1. Blood sugar. 2. Serum cholesterol 3. Lipid profile. 4. Thyroid function test( if necessary) Criteria for overall assessment of the therapy

Grade -1 Complete remission

100 % relief of signs and symptoms >20 % reduction of body weight

Grade-2 Marked improvement

>75% relief in signs and symptoms >15% reduction in body weight

Grade-3 Moderate improvement

50-70% relief in signs and symptoms 10-15% reduction in body weight

Grade-4 Mild improvement

25-50% relief in signs and symptoms 6-10% reduction in body weight

Grade-5 Negligible improvement

<25% relief in signs and symptoms <6% reduction in body weight

Grade-6 Stable

Undiminished signs and symptoms No reduction in body weight

Statistical analysis The information gathered on the basis of observation made about various parameters was subjected to statistical analysis in terms of mean standard deviation (SD) and standard errors (SE). Paired t test was carried out at p<0.05, p<0.01, p<0.001. The obtained results were interpreted as- Insignificant = p > 0.05 Significant = p <0.01 Lightly Significant = p < 0.001 OBSERVATIONS The data comprehended while conducting this clinical study on various parameters are significant clues regarding the aetiopathogenesis and progression made in

this regards are analytically compounded. The sample was split up into five classes of 10 yrs. age group. The minimum age of the patient in this study was 17 yrs. and maximum age was 52 yrs. Maximum patients were recorded in age group 31-40 yrs (33.33%), followed by 21-30yrs (29.17%), 51-60 yrs (20.84%) and minimum was in two age group of 11-20 yrs and 41-50 yrs (8.33% each). Majority of the patients were female i.e. 75%, whereas only 25% patients were male. 66.66% of patients in this series were Hindu, 33.33% of patients were Muslims, 66.66% of them were housewives and were involved in domestic work only, 16.66% of them were business men and 8.34% of patients were service men and students each. It indicated that housewives were mostly obese and labor class people were not obese. 8.33% of patients were illiterate although 81.77% were put in literate category. Maximum i. e 87.50% were married, 12.5% were unmarried. 54.16% of patients were belonged to lower middle class, and 33.33% of patients were from middle class and remaining 12.5% of patients were belonged to upper middle class, where as no patients were belonged to lower class. 83.33% were urban inhabitant and remaining 16.66% were belonged to rural areas. Prakriti wise (Sharirik and Mansik) distribution has been dealt. Kapha- pitta prakriti recorded maximum in this sample i.e 58.33%, followed by Vata- Pitta and Kapha -Vata prakriti of 20.83% each. The status of Manasa prakriti was observed, 58.33% of patients were of Tamsik prakriti and 41.66% were of Rajsika prakriti. In Sara wise distribution 62.50 % patients were of Madhyam Sara, while 25% were Pravar Sara and 12.5% of patients were Aavara Sara. In Satva wise distribution 45.13% of patients were of Madhyam Satva 37.5% were of Avara Satva and 16.66% were of Pravar Satva . The Samhanana wise distribution of patients showed that majority of patients (62.50%) had Madhyam Samhanana followed by Pravara Samhanana 25% , remaining 12.50% patients posses the Avara Samhanana. 54.16% patients were having Avara Satmya, while 37.5% patient were having Madhyam Satmya and 8.33% were having Pravara Satmya . The height wise distribution revealed that maximum number of patients (62.5%) belonged to height of 161-170cm, 25.6% of patients were belonged to height of 141-150 cm range, 37.5% of patients were having weight in 81-90 kg range, 25% of patients were having weight in 91-100kg range, 20.83% of patient were having weight in 71-80 kg range and 16.66% were belonged to weight range of 61-70kg. 54.16% were having Madhyam Vayayam shakti, followed by 37.5% Avara Vayayam shakti, remaining 8.33% were having Pravar Vayayam Shakti. Dietary pattern of the study sample depicted that vegetarians were 58.33%, where as remaining 41.66% were accustomed to mixed diet, 58.33% of patients habituated with Vishamasana, 25% of patients had Adhyasana and 16.66% patients stick with Samasana. Analysis on the basis of Dominant Rasa in diet showed that maximum number of patients had an inclination towards Madhura rasa and Katu rasa that is 54.66% and 41.16% respectively. Affinity for Lavana rasa was 4.16%,

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62.55% patients had krura kostha , while 20.83% patients had Mrudu kostha and remaining 16.66% patients had Madhyam kostha. 58.33% were not doing any exercise, 29.16% patients were doing less or irregular exercise, where as 12.5% of the patients were doing some exercise but regularly. Maximum no of patients’ i.e. 50% belonged to the BMI range30-45kg/m2, 25% patients were belonged to the BMI range 25-30kg/m2, 20.84% patients belonged to the BMI range 35-40kg/m2 and 4.16% patients belonged to the BMI 40kg/m2. Biochemical

study of 24 patients reveled maximum no. of patients i.e. 54.16% were having S. cholesterol <200mg/dl, 41.66% were having S. cholesterol in between 200-250mg/dl and remaining 4.16% were having S. cholesterol in between 250-300mg/dl. Most of the patients i.e. 83.34% were having S. Triglyceride level <200mg/dl, while remaining 16.66% were having S. Triglyceride in between 200-500mg/dl.

RESULTS

Table 4: Effect of Lekhan basti and Lekhan vati on cardinal signs and symptoms in Group-A Cardinal signs and

symptoms Mean score %

relief SD SE t n p

BT AT Chalatva 2.41 1.33 44.81 0.38 0.11 10.54 12 <0.001 Daurbalya 2.91 0.66 77.31 0.62 0.17 13.23 12 <0.001 Daurgandhya 2.00 0.50 75.00 1.02 0.29 4.65 12 <0.001 Svedadhikya 2.41 1.00 58.50 0.66 0.19 7.42 12 <0.001 Khudrasvasa 3.00 0.58 80.66 0.86 0.24 9.37 12 <0.001 Pipasa atiyoga 2.35 1.08 56.44 0.71 0.20 5.8 12 <0.001 Nidradhikya 3.00 1.33 55.66 0.51 0.14 11.28 12 <0.001 Kshudhadhikya 3.16 1.16 71.29 0.75 0.21 10.71 12 <0.001 Snigdhangata 2.76 1.26 63.11 0.38 0.11 16.66 12 <0.001 Alasya 3.00 0.41 87.59 0.49 0.14 19.00 12 <0.001

Table 5: Effect of Lekhan basti and Lekhan vati on body weight and BMI in Group-A

Objective criteria Mean score %relief SD SE t n p BT AT

Weight in Kg 79.62 71.6 10.07 3.39 0.97 8.37 12 <0.001 BMI(Kg/m2) 32.95 29.74 9.74 1.62 0.46 7.43 12 <0.001

Table 6: Effect of Lekhan basti and Lekhan vati on circumference in Group-A

Circumference (in cm)

Mean score % change

SD SE t n p BT AT

Chest 103.60 97.91 5.49 2.23 0.67 8.32 12 <0.001 Abdomen 111.00 104.1 6.16 1.72 0.49 13.42 12 <0.001 Buttock 118.90 113.23 4.76 1.97 0.56 9.07 12 <0.001 Mid arm 32.83 31.33 4.56 1.00 0.28 3.57 12 <0.05 Mid thigh 61.66 58.08 5.80 1.44 0.41 6.29 12 <0.001

Mid calf muscle 39.50 38.00 3.79 0.79 0.22 6.81 12 <0.001

Table 7: Effect of Lekhan basti and Lekhan vati on skin fold thickness in Group-A Skin fold thickness

Mean score % change

SD SE t n p BT AT

Biceps 2.64 2.52 4.54 0.04 0.015 12 12 <0.001 Triceps 2.77 2.65 4.33 0.03 0.009 15.13 12 <0.001

Sub scapular 3.54 3.36 5.08 0.05 0.014 18.10 12 <0.001

Table 8: Effect of Lekhan vati on cardinal signs and symptoms in Group-B Cardinal signs and

symptoms Mean score %

relief SD SE t n p

BT AT Chalatva 2.33 1.50 35.62 0.38 0.11 7.54 12 <0.001

Daurbalya 2.66 0.92 65.41 0.79 0.22 8.68 12 <0.001 Daurgandhya 1.50 0.75 50.00 0.96 0.27 2.77 12 <0.001 Svedadhikya 2.33 1.00 57.08 0.38 0.10 11.60 12 <0.001 Khudrasvasa 2.41 0.75 75.93 0.38 0.11 16.63 12 <0.001

Pipasa atiyoga 1.75 0.83 52.57 0.66 0.19 4.78 12 <0.001 Nidradhikya 2.25 1.00 55.55 0.75 0.21 5.95 12 <0.001

Kshudhadhikya 2.00 1.11 45.00 0.74 0.21 3.85 12 <0.01 Snigdhangata 2.41 1.16 51.86 0.75 0.21 5.95 12 <0.001

Alasya 2.58 0.75 70.93 0.93 0.27 6.77 12 <0.001

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Table 9: Effect of Lekhan vati on body weight and BMI in Group-B

Objective criteria

Mean score % change

SD SE t n p BT AT

Weight in Kg 82.20 78.08 5.01 1.28 0.36 17.4 12 <0.001 BMI(Kg/m2) 33.08 30.62 7.43 0.66 0.19 12.97 12 <0.001

Table 10: Effect of Lekhan vati on circumference in Group-B

Circumference (in cm)

Mean score % change

SD SE t n p BT AT

Chest 103.83 99.58 4.09 2.37 0.86 4.94 12 <0.001 Abdomen 111.41 105.83 5.00 3.35 0.96 5.72 12 <0.001 Buttock 118.5 114.6 3.29 1.15 0.33 13.12 12 <0.001 Mid arm 33 32 3.03 1.27 0.36 2.77 12 <0.05 Mid thigh 56.58 54.16 4.27 1.87 0.54 4.31 12 <0.001

Mid calf muscle 37.66 36.25 3.25 0.98 0.28 5.92 12 <0.001

Table 11: Effect of Lekhan vati on skin fold thickness in Group-B Skin fold thickness

Mean score % change

SD SE t n p BT AT

Biceps 2.61 2.54 4.23 0.03 0.008 11.01 12 <0.001 Triceps 2.88 2.77 3.81 0.032 0.009 14.06 12 <0.001

Sub scapular 3.60 3.44 4.44 0.04 0.011 15.32 12 <0.001

Table 12: Percentage relief in Subjective criteria Sr. No.

Subjective criteria

% Relief by LBLV Therapy in Group-A

% Relief by LV Therapy in Group-B

1 Chalatwa 44.81 35.62 2 Daurvalya 77.31 65.44 3 Daurgandhya 75.00 50.00 4 Swedadhikya 58.50 57.08 5 Kshudrasvasa 80.66 75.93 6 Pipasatiyoga 56.44 52.57 7 Nidradhikya 56.66 55.55 8 Kshudhadhikya 71.29 45.00 9 Snigdhangata 63.11 51.86 10 Alasya 87.59 70.93

Table 13: Percentage relief in Objective criteria

Objective criteria % Relief by LBLV Therapy in Group-A

% Relief by LV Therapy in Group-B

Body weight 10.07 5.01 BMI 09.74 7.43

Measurement of circumference Chest 5.49 4.09

Abdomen 6.16 5.00 Buttock 4.76 3.29 Mid arm 4.56 3.03

Mid Thigh 5.80 3.28 Mid calf 3.79 4.27

Skin fold thickness Biceps 4.54 4.23 Triceps 4.33 3.81

Sub scapular 5.04 4.44

Table-14: Over all effects of Therapies Treatment effect No. of patients for LBLV

therapy in Group-A No. of patients for

LV therapy in Group-B Total no.

of patients % relief

Complete remission 00 00 00 00.00 Marked remission 02 01 03 12.50

Moderate remission 07 05 12 50.00 Mild remission 03 03 06 25.00

Negligible 00 03 03 12.50 Stable 00 00 00 00.00

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Graph 1: Percentage relief in Subjective criteria

Graph 2: Percentage relief in Objective criteria DISCUSSION Sthoulya is a Kapha-Vata pradhan Tridosaj vyadhi and Acharyas has recommended Vataghna and Kaphaghna annapanna and aoushadhi for this disease. So we have selected lekhan basti as it has foremost action on Vata and for proper lekhan karma, we have selected lekhan vati. We have selected lekhan basti for Sthoulya as it has less risk, safe and easy for administration in comparison to Vaman and Virechan. Probable action of lekhan basti Lekhan Basti was prepared by the combination of the taila, madhu, gomutra, lavan, which consist ushana and tikhna guna. Taila has anupravan bhava. Due to that it passes through illioceacal valve and reaches up to Ghrahani, where it absorbed. Basti inhibits the fat absorption by reaching upto Grahani. Hence it pacify Saman vayu and brought Jatharagni to its normal level and activate the Vyana vayu to break the Sroto sang and synergize the action of Lekhan therapy at the cellular level. The basti drugs consists of kasaya, tikta and katu

rasa, so that these properties potentiate the action of lekhan therapy. Probable action of lekhan ghanavati The properties of Lekhan ghanavati is tikta , katu , kashya rasa and having laghu , rukshya, tikshna guna, ushana veerya, katu vipaka, kaphavata shamak and Aakash, Vayu and Agni are the panchbhautic constituents. Out of 12 drugs in this combination first ten drugs have lekhan property as mentioned by Charak and Varun and Vidang has Medohara properties. By this lekhan and medohara action, the quantity of meda (adipose tissue) reduced from the dependable parts of the body, which brought Laghuta, and relief in Chalatva. Though the udipta jathargni get pacified, so kshudhadhikya diminished. Sweda is the mala of meda, so reduction of meda inhibit excess sweating. Due to deepan pachan properties of this combination, nutrients get digested and dhatu poshakansa can easily reach to respective dhatus enhancing the proper nutrition to all dhatus. So it seems that the above combination not only acts on symptomatology of the disease but also checks its

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progression by hitting the basic pathological process i.e. Medovaha Srotosanga and Meda Sanchaya. CONCLUSION From this clinical trial we evident that Sthoulya is a disease of hampered physiology of Dhatavagni which further cause over production of Meda. Dietary habits of patients were found to be unwholesome, as patients liked to eat only madhura rasa pradhan ahara, atisheeta, snigdha Dravya, kaphakar ahara. In 30% of patients, abdominal pain was observed after administration of Lekhan Basti. It indicated the effect of Lekhan therapy at very basic level. Just after lekhan basti therapy, reduction of average weight loss was 1.5 kg, where as post therapeutically weight loss was 9.5 kg. It suggested that after lekhan basti therapy srota sanga broken and lekhan karma took place properly. Comparison of overall effect in patients of both the groups showed that lekhan basti purvak lekhan vati therapy offered better result. Although Lekhan vati also proved its effect in alleviating symptomatology of Sthoulya but to lessen extent. In this study only one patient has complained vomiting after administration of Lekhan Basti. 20% of patients in group-A and 30% of group-B showed Sira Shoola during the course of treatment. No other side effects were encounter during the treatment period or follow up period of therapy. In follow up of patients, the weight gain after one month lekhan therapy in group -A was 0%, where as in group –B, it was 3%. The synergistic action of lekhan basti was observed in group -A. Decrease in cholesterol and skin fold thickness proved the efficiency of lekhan therapy but better result was observed in lekhan basti and lekhan vati group. From above study it was evident that superiority of lekhan basti therapy was proved beyond doubt by many research works. It is suggested that further studies should be carried out not only to assess the efficacy of the drug but also to find out the most effective therapeutic module. Due to certain limitations it was not possible to carry out chemical analysis of formulation. In future a pharmacological as well as phytochemical study may be planned.

ACKNOWLEDGEMENT I acknowledge gratitude to Vd. B.P Parmar, Principal and superintendent of Govt. Akhandananda Ayurved College and Hospital, Ahmadabad for his extensive support in providing all resources in the OPD and IPD of the hospital as well as in Pharmacy. I express my gratitude to my esteemed Guide Prof. V.N Lathia, H.O.D in the Dept. of K.C (PG) for his inspiring spirit and parental affection besides his subject knowledge and direction that helped in accomplishing this Herculean work. I acknowledge gratitude to my co-guide Dr. V.H Jhani, Dept. of K.C (PG), Akhandananda Ayurved College and hospital, Ahmadabad, for his valuable Co- operation in this project. I should express my special gratitude to the H.O.D Dept. of Pharmacognocy, IPGT and RA for identification and authentication of the Raw material before preparation of the desired formulation. I would express my sincere gratitude to Mr. Rjni, in charge Dang Gilla Ayurved Sahakari Pharmacy, Govt. of Gujarat, for his all support in preparation of the ingredients of lekhan basti and lekhan vati. I owe my thanks to my friends, hospital staffs, laboratory staffs, library staffs and patients for their sincere support in this clinical trial. REFERENCES 1. Susruta, Susruta Sahmita, , Ayurveda Tatwa Sandeepika Hindi

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