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| CLINICAL RESEARCH |
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| Year : 2014 | Volume
: 35
| Issue : 1 | Page : 28-34 |
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Clinical evaluation of Lekhaniya Kashaya Vasti in the management of Sthaulya (obesity)
Meera Antiwal1, Jai Prakash Singh2, Shri Kant Tiwari1
1 Department of Kaya Chikitsa, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India
2 Department of Kaya Chikitsa, National Institute of Ayurveda, Jaipur, Rajasthan, India
| Date of Web Publication | 29-Sep-2014 |
Correspondence Address:
Jai Prakash Singh
Lecturer, P.G. Department of Kaya Chikitsa, National Institute of Ayurveda, Madhav Vilas Palace, Amer Road, Jaipur - 302 002, Rajasthan
India
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/0974-8520.141907
 Abstract | | |
Background: Obesity is considered the world's oldest metabolic disorder. It is not a single disease entity, but a syndrome with many causes including combination of genetic, nutritional and sociological factors. The World Health Organization (WHO) considers obesity as "Insidious, creeping pandemic which is now engulfing the entire world". Diet and life-style play a significant role both in the development and control of obesity Sthaulya (obesity). In Ayurveda, Acharyas have mentioned about the use of Lekhaniya Vasti to manage the Sthaulya. Aim: To evaluate the efficacy of Lekhaniya Kashaya Vasti in patients of Sthaulya. Materials and Methods: A total of 70 patients of Sthaulya were registered. Further they were divided into 2 groups each having 35 patients. In Group I (Lekhaniya Kashaya Vasti) group out of 35 patients 32 and in Group II (Pathya) group out of 35 patients 33 completed the follow-up. Results: In Group I, mean change was observed in body mass index (P < 0.001), waist hip ratio (P < 0.001). Overweight (P < 0.001), Kshudraswas (breathlessness) (P < 0.001) and Nidraadhikyata (excessive sleep) (P < 0.001) which is statistically significant in comparison with Group II. Conclusion: Trial drug is very good combination for Medoghna activity. Keywords: Lekhaniya Vasti , metabolic disorder, obesity, Pathya, Sthaulya
How to cite this article:
Antiwal M, Singh JP, Tiwari SK. Clinical evaluation of Lekhaniya Kashaya Vasti in the management of Sthaulya (obesity). AYU 2014;35:28-34 |
| Introduction | |  |
Obesity is a global problem; affecting estimated 300 million people world-wide its prevalence is increasing in both developed and developing countries throughout the world. [1] Obesity is a world-wide epidemic that is characterized by excess adipose tissue and that contributes to numerous chronic diseases and early mortality. [2],[3],[4],[5] This epidemic has received both national and international attention due to obesity's detrimental impact on health, the enormous economic burden it imposes and its increasing prevalence. [6] The present epidemic of overweight and obesity in the whole world is an unintended consequence of the economic, social and technological advances realized during the past several decades. [7] With the onset of the industrial revolution increase in the average body size of the population is an additional concern to health care professional. Now a day in fast pace life people are more inclined to food which low in cost, palatable and readily available in prepackaged forms, but it serves high caloric density resulting in obesity. Labor-saving technologies like electronic devices in home have greatly reduced the amount of physical activity that used to be the part of everyday life in olden days, have further promoted a sedentary life-style, particularly among children. The elevating Body Mass Index (BMI), particularly caused by abdominal or upper-body obesity, has been associated with a number of diseases and metabolic abnormalities, many of which have high morbidity and mortality.
Objective
The objective of the study is to evaluate the efficacy of Lekhaniya Kashaya Vasti in patients of Sthaulya on subjective, objective and biochemical parameters.
| Materials and Methods | | |
The present study was carried out at Kaya Chikitsa Out Patient Department and Indoor Patient Department of Sir Sunder Lal Hospital, Institute of Medical Sciences, Banaras Hindu University, Varanasi between the periods of June 2009 to July 2010. A total of 70 patients of Sthaulya were divided into 2 groups in each group 35 patients were registered, in Group I out of 35 patients 32 and in II group out of 35 patients 33 completed the follow-up.
Ethical consideration
The Institutional Ethical Review Committee of Banaras Hindu University approved the study (Ref. No. Dean/(Ay.) 2008-09/612). A specially prepared informed consent was maintained and sensitive issues, confidentiality, the privacy and safety of subjects were protected throughout the trial.
Study design
This is a randomized controlled stratified, open level study.
Inclusion criteria
- The patients age range between 20 and 60 years
- The patients having clinical signs and symptoms of Sthaulya
- The patients having BMI in between 25 and 39.99 kg/m 2 .
Exclusion criteria
- Patients below the age of 20 years and above 60 years
- Patients with hypothyroidism
- Patients undergoing long-term steroid therapy
- Patients with diabetes and malignant hypertension
- Patients with evidence of renal, hepatic and cardiac involvement
- Patients with BMI more than 40 kg/m 2 and less than 25 kg/m 2 .
Every patient was registered after fulfilling the inclusion criteria underwent assessment of symptoms and different components of weight, BMI, anthropometric parameters.
Follow-up study
A total of three follow-ups were done at the interval of 1 month each and all the subjective and objective parameter were recorded each time.
Study groups
Treatment schedule for Group I (n = 32)
In this group, Lekhaniya Kashaya Vasti was given to total 35 registered patients and out of 35 patient 32 completed the course.
Contents and preparation of the Lekhaniya Kashaya Vasti
It has been formulated from different Ayurvedic texts on the basis of their properties which are described under Sthaulya Chikitsa and its contents are as fol1ows:
Chitraka (Plumbago zeylanica L.) 2 g, Mustaka (Cyperus rotundus L.) 2 g, Shunthi (Zingiber officinale Roscoe.) 2 g, Aamalaki (Emblica officinalis Gaertn.) 2 g, Haritaki (Terminalia chebula Retz.) 2 g, Vibhitaka (Termenalia bellirica Roxb.) 2 g, Vidang (Embelia ribes Burm. f.) 2 g, Guggul (Commiphora mukul (Stocks) Hook.) 3 g, Apamargatandul (Achyranthes aspera L.) 2 g, Amrita (Tinospora cordifolia (Thunb.) Miers) 2 g, Arjun (Termenalia arjuna (Roxb.) Wight and Arn.) 2 g, Bilwa (Aegle marmelos (L.) Correa. ex Roxb.) 2 g, Vacha (Acorus calamus L.) 1 g, Katuka (Picrorhiza kurroa) 1 g.
In addition to all contents of Lekhaniya Kashaya, the following drugs were added in the Lekhaniya Kashaya Vasti prepration:
- Saindhava Lavana-10 g,
- Madhu (Honey)-10 g,
- Gomutra (Cow urine)-100 ml,
- Tila Taila (Sesame oil)-100 ml
Process of administration of Lekhaniya Kashaya Vasti
Langhana therapy-light meal (Yusha, Manda, Krishara).
Deepana-Chitraka Churna 1.5 g two times in day with luke warm water before meal for 3 days.
Pachana-Chitrakadi Vati 2 Tablet (500 mg) two times in day after meal for 3 days.
Snehana Karma-Abhyanga with Tila Taila was followed by Swedana Karma (Sarvanga Nadi Sweda) starting from day 1 st to 16 th day.
- From 4 th day of treatment-Tila Taila Anuvasana Vasti was given
- 5-7 th day-Lekhaniya Kashaya Vasti
- 8 th day-Tila Taila Anuvasana Vasti
- 9-11 th day-Lekhaniya KashayaVasti
- 12 th day-Tila Taila Anuvasana Vasti
- 13-15 th day-Lekhaniya Kashaya Vasti
- 16 th day-Tila Taila Anuvasana Vasti.
Duration
This procedure was repeated once in every month consecutively for period of 3 months.
Treatment schedule for Group II (n = 33)
To this group, the Pathya Ahara-Vihara was given and out of 35 registered patients 33 completed the course. General scheme of Pathya which was advised to the patients [Table 1].
The calorific value of this diet was estimated. It provides 800-1100 kcal/day with 9 g fibers, 40 g fat, 50 g protein and 100 g carbohydrate.
Energy consuming practices in Pathya groups
Patients were advised to practice regular exercise. Here are some specific energy consuming practices in Pathya group (as per the Ayurverdic texts).
Patients were advised to sleep only 5-6 h during night and avoid sleep during day time. Patients were totally prohibited to take sweet and salty items, fried items, fast food, Chhole, Rajma, Urad, meat, milk products, cold drinks, chocolate, alcohol substances, fruits, dry fruits, curd, pickles, Papad, potato, sweet-potato, bread, butter, Paneer, fermented items etc.
Clinical assessment of the disease
Subjective criteria
Angachalatva
- Absence of Chalatva-0
- Little visible movement after fast movement-1
- Little visible movement even after moderate movement-2
- Movement after mild movement-3
- Movement even after changing posture-4.
Kshudra Shwasa
- No Dyspnea-0
- Dyspnea after heavy works but relieved soon and up to tolerance-1
- Dyspnea after moderate works but relieved later and up to tolerance-2
- Dyspnea after little works but relieved later and up to tolerance-3
- Dyspnea after little works but relieved later and beyond tolerance-4
- Dyspnea in resting condition-5.
Gatrasada
- No fatigue-0
- Little fatigue in doing hard work-1
- Moderate fatigue in doing routine work-2
- Excessive fatigue in doing routine work-3
- Excessive fatigue even in doing little work-4.
Atikshudha
- Person not at all taking food-0
- Person taking food in less quantity once a day-1
- Person taking food in less quantity twice in a day-2
- Person taking food in moderate quantity twice in a day-3
- Person taking food in normal quantity twice in a day-4
- Person taking food in excessive quantity thrice in a day-5.
The assessment was carried out before starting the treatment and at each 3 follow-ups of 30 days and the improvement was assessed on the basis of percentage relief and statistical evaluations.
Criteria for assessment of overall effects
For the gross assessment of the result obtained with the clinical trial, the response of the treatment was determined in terms of:
Subjective improvement
Patients were specifically asked about feeling of well-being and improvement in Angachalatva, Atishudha, and Kshudra Shwasa at each follow-up of treatment.
Clinical improvement
Reduction in weight, BMI, arm circumference, Waist Hip Ratio (WHR) was noted at each follow-up.
Hematological and biochemical assessment
Lipid profile, liver function test value was recorded before and after the treatment in registered cases to evaluate the nature and extent of change in relation to course of disease. Hemoglobin in g%, total leucocytes counts, differential leucocytes counts, Erythrocyte Sedimentation Rate (ESR), serum creatinine, blood urea and blood sugar values were recorded before and after the treatment in registered cases to evaluate the safety profile of the drug.
Statistical analysis
The data collected were transferred on master chart showing various items/variables in columns and subjects in rows. The analysis of data was performed using statistical software SPSS version 16 and it is developed by International Business Machines Corporation.
Intra-group (within the group) comparison
To test the significance of mean of difference of paired observations (before treatment v/s after treatment) paired t-test was applied.
Inter-group comparison (between the groups)
In case of more than two independent groups, one-way analysis of variance was applied and value of F test was determined, whenever F test resulted statistically significant, post-hoc test was applied for multiple comparisons, identifying significant pairs of groups.
| Results | | |
In symptoms like Angachalatva, significant mean reduction was observed and inter group comparison was not significant whereas in Kshudra Shwasa, Gatrasada, Atipipasa symptoms significant mean reduction was observed and Group I was more effective than Group II and on inter group comparison Group I was significant than Group II [Table 2] and [Table 3]. | Table 2: Effect of therapy on subjective parameters in 65 patients of Sthaulya
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 | Table 3: Comparative effect of therapy on subjective parameters in 65 patients of Sthaulya (Comparison between the groups on difference of BT and AT by one way ANOVA test)
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For an individual, obesity is usually the result of an imbalance between calories consumed and calories utilized. For the present study Lekhaniya Vasti was selected to manage the disease Sthaulya. In whole, with the use of Lekhaniya Vasti, highly significant mean reduction in weight, BMI and WHR were observed in Group I as compare to Group II while in Group II mean weight, BMI and WHR are remained more or less similar at every follow-up and on inter group comparison Group 'I' was better than Group 'II' [Table 4] and [Table 5]. | Table 4: Effect of therapy on objective parameters in 65 patients of Sthaulya
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 | Table 5: Comparative effect of therapy on objective parameters in 65 patients of Sthaulya (Comparison between the groups on difference of BT and AT by one way ANOVA test)
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In the present clinical study statistically no change was observed in blood urea, blood sugar, serum creatinine and liver function test after trial therapy. Significant mean reduction was observed in serum Low-Density Lipoprotein (LDL), serum triglycerides, Very Low Density Lipoprotein (VLDL) and cholesterol level in I group than Group II, whereas in level of serum High-Density Lipoprotein (HDL) no significant change was observed after trial therapy in both the groups [Table 6] and [Table 7]. Safety profile of the drug serum bilirubin, serum glutamic oxaloacetic transaminase, serum glutamic-pyruvic transaminase, alkaline phosphate, serum creatinine and blood urea, there was no significant change in the level of these biochemical parameters within the both groups [Table 8],[Table 9] and [Table 10]. | Table 6: Effect of therapy on lipid profile test in 65 patients of Sthaulya
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 | Table 7: Comparative effect of therapy on Lipid profile in 65 patients of Sthaulya (Comparison between the groups on difference of BT and AT by one way ANOVA test)
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 | Table 8: Effect of therapy on liver function test in 65 patients of Sthaulya
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 | Table 9: Effect of therapy on other biochemical parameters in 65 patients of Sthaulya
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 | Table 10: Comparative effect of therapy on other biochemical parameters in 65 patients of Sthaulya (Comparison between the groups on difference of BT and AT by one way ANOVA test)
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| Discussion | | |
Probable mode of Action of Lekhaniya Kashaya Vasti
- Most of the time there is presence of Ama at Dhatu level, on starting Vasti schedule with Anuvasan Vasti, it can increase the Ama so just to prevent the formation of Ama and to maintain the Samaagni, Deepana-Pachana therapy was given
- As a whole the effect of Vasti is encolinic (action on tissue of colon), endcolonic (action inside colon) and diacolonic (for systemic action). The mean retention time of Lekhaniya Kashaya Vasti observed was 35 ± 4.5 min. Thus Vasti Dravyas when reaches in large and small intestine get absorbed from intestinal mucosa, further, due to Laghu, Ushna and Tikshna Guna (properties) of Vasti Dravaya, obstruction of channels are broken down the and morbid material from all over the body are expelled out, thus breaks the pathogenesis of disease Sthaulya (obesity) [8]
- Vasti help in Vatanulomana by Tikta (bitter), Katu (astringent) Rasa (taste) and Tikshna Guna present in trial drug, thus helps in the correction of passage of Apana Vayu and these qualities irritate the intestine leading to increased contraction of intestine hence provides less time for absorption of fat from intestine. Vasti therapy may be stimulator for many intraluminal, luminal and whole body function [9]
- Trial drug possess cholagogue property, Tikta, Katu Rasa, Tikshna properties irritate the intestine leading to increased propulsive movement of intestine. [10] Hence, provides less time for absorption of fat from intestine
- Dravyas present in the trial drug possess choleretics action which causes excretion of bile which further leads to decrease absorption of fat from intestine [10]
- Trial drug has, Kutki, have irritant property which damage the structure of villi in intestine hence causes decreased capacity for absorption [11]
- Sesamum oil has Katu and Tikta Rasa property. Due to this, it reduces excessive Meda of the body. It also contain Agnideepaka and Vata Nashak property. Agnideepaka property enhances the Jathragni as well as Dhatwagni. Excessive Abaddha Meda will change in Baddha Meda due enhancement of Jatharagni[12]
- Tikshna Guna acts on Srotas (channels) immediately and pierces the smallest cells of the vessels and removes the obstruction caused by lipids. [13] These Gunas also activate the Jatharagni and Dhatvagni and maintain their status. [14] Tikta, Katu Rasa, Laghu, Ushana properties present in trial drug are very useful for Ama Pachana, so by means of these properties digestion of Ama, restoration of Agni (Deepana) at the Dhatu level, removal of excessive Kledaka Kapha takes place. Tikta and Katu Rasa are also Kleda and Meda Nashaka.[15],[16] Tikta and Kashaya Rasas have Lekhana Guna that scraps out excessive Kapha and Meda from srotas. In addition to Lekhana, Kashaya Rasa also has the property of Shoshana[17],[18] which absorbs the excessive fluids and lipid substances caused by hypercholesterolaemia. Laghu Guna acts as Kaphahara, reduces the tissue weights (Langhana) [15],[19] and clears the channels of the body (Srotoshodhana). All Dravyas are Ushna in Virya, which oppose any increment of Kapha and Medas by the Vilayan property.[18],[20]
| Conclusion | | |
In present clinical study, significant reduction in BMI and WHR was seen in Group I as compared to Group II. The Lekhaniya Kashaya Vasti is effective (P < 0.001) for weight reduction. Hence, it can be concluded that trial drug is a very good combination for Medoghna activity.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7], [Table 8], [Table 9], [Table 10]
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