ISSN-23205091

International Ayurvedic Medical Journal

Research Article

CLINICAL EVALUATION OF THE EFFICACY OF VACHADI COMPOUND (KALPITA YOGA) AND SHIRODHARA BY KSHEERA IN THE MANAGEMENT OF RAKTAGATA VATA W.S.R.TO HYPERTENSION Dr. Deshmukh Rohini Dr. Kute Arun Dr. Buddhi Prasad Dr. Rathod Motilal Dr. Joshi Ram Kishor Department of Kayachikitsa, NIA, Jaipur ABSTRACT It has been estimated that hypertension accounts for 6% of deaths worldwide. The burden of hypertension increases with age, and among individuals aged 60, hypertension prevalence is 65.4%. Essential hypertension is high blood pressure with unknown aetiology. Out of total hypertensive patients, 95% patients are having essential hypertension.On the basis of involved and Lakshana it can be said that that it is a Vata vyadhi along with involvement of kapha, pitta dosha and rakta dhatu. In the present study out of total 34 patients, 30 patients completed clinical trial 15 subjects in group-I, treated with oral drug Vachadi Compound and rest 15 subjects treated with ksheerdhara in group-II. Both groups were found effective in reducing the systolic and diastolic blood pressure and also alleviate the symptoms of essential hypertension. Group II showed better results than Group I in subjective and objective parameters. Keywords: Raktagata vata, shirodhara, Hypertension, vachadi compound INTRODUCTION Cardiovascular disease is the leading cause of death and disability in developing nations and increasing rapidly in the developing world. By the year 2020, it is estimated that cardiovascular diseases will surpass infectious diseases as the worlds leading cause of death and disability1. It has been estimated that hypertension accounts for 6% of deaths worldwide2. The burden of hypertension increases with age, and among individuals aged 60, hypertension 2 prevalence is 65.4%. . It is likely that hypertension represents a polygenic disorder in which a single gene or combination of genes act in concert with environmental exposures to contribute only a modest effect on blood pressure. It has long been suspected that chronic stress may be a risk factor for hypertension.3 Essential hypertension is psychosomatic disease with unknown aetiology, accounting for 95% of total hypertensive patients. There are so many references in Ayurveda classics supporting the presumption that, the disease hypertension was present in the ancestral society, but in a dormant fashion, hence the descriptions are scattered here and there; like Pakshavadha, Shirahshula, Shotha, Mutra kriccha etc. in classics. Perhaps the disease was not obtained very often in the population of ancient era and due to lack of a sphygmomanometer it could not come to

Joshi Et Al; Efficacy Of Vachadi Compound (Kalpita Yoga) And Shirodhara By Ksheera In The Management Of Raktagata Vata W.S.R.To Hypertension

human knowledge as noticeable as now days. The descriptions of related organs like Hridaya, Dhamani and Sira etc. can be traced back in our epics. AIMS AND OBJECTIVES Present research study was conducted with following aims and objectives. 1. Conceptual and clinical study on essential hypertension vis--vis Raktagata Vata. 2. To evaluate the clinical efficacy of Vachadi Compound in the management of essential hypertension. 3. To evaluate the clinical efficacy of Ksheeradhara (Shirodhara) in the management of essential hypertension. 4. To compare the efficacy of Vachadi Compound and Ksheeradhara in the management of essential hypertension. MATERIALS AND METHODS Selection of the Patients The 34 clinically diagnosed patients of essential hypertension were selected randomly from OPD/IPD of Arogyashala, NIA, Jaipur. Out of these 30 patients have completed the trial and 4 patients were dropped out. INCLUSION CRITERIA a) Patients between the age group of 25 to 70 years in either sex presenting with cardinal symptoms of hypertension. b) Patients having elevated blood pressure i.e. above 140/90 mm of Hg. c) Patients willing to sign the consent form. EXCLUSION CRITERIA a) Patients with age below 25years and above 70 years. b) Patients having secondary hypertension, malignant hypertension i.e. blood

pressure above 200/140 mm of Hg, Pregnancy induced hypertension and hypertensive lactating mothers. c) Patients having any other serious illness like coronary artery disease, cerebrovascular disease, renal function impairment. d) Patients having complications of the hypertension like hypertensive retinopathy. CLINICAL TRIAL
30 diagnosed patients had undergone for clinical examination and drug therapy along with necessary dietary advice.

DETAILS OF CLINICAL TRIAL a) Experimental Groups: 34 clinically diagnosed and confirmed patients of Hypertension were randomly divided into two groups. Out of 34 patients, 2 in each group were dropped out. GROUP 1- 15 registered patients of Hypertension was administered Vachadi Compound -2 Capsules TDS for a period of 1 Months. GROUP 2- 15 registered patients of Hypertension was administered Shirodhara for a period of 1 Month. CRITERIA FOR ASSESSMENT Subjective Parameters-Symptoms of the patients viz. Shirshula, Hriddravata, Klama, Anidra etc.were assessed before and after trial. A) Objective Parameters It includes Blood Pressure measurement of the patients.

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Joshi Et Al; Efficacy Of Vachadi Compound (Kalpita Yoga) And Shirodhara By Ksheera In The Management Of Raktagata Vata W.S.R.To Hypertension

D) Hamilton Anxiety Scale - This scale C) Laboratory Parameters Laboratory investigations of patients viz. was used to assess psychological Hb%, TLC, ESR, Blood sugar, Lipid involvement of the patients. Profile, Blood urea, Serum creatinine were done before and after the treatment. Table 1: Showing contents of trial drug Sr.no Sanskrit name Botanical name Part used Ratio 1. Vacha Acorus calamus Root Valeriana wallichi Root 1/2 Convolvulus Panchanga 1 pluricaulis 4. Punarnava Boerhavia diffusa Root 1 Table 2: Showing observations in the Clinical study Observations Group % Age 46-55 yrs 35.29% Sex Female 55.88% Religion Hindu 70.59% Occupation Housewives 44.12% Marital Status Married 82.35% Socio-economic status Middle 61.76% Diet Mixed 52.94% Nature of Work Sedentary 73.52% Nidra Alpa Nidra 58.82% Malapravritti Grathita and Prakrita each 47.05% Addiction Tea, Smoking and Alcohol each 97.06%, 23.52% Sharira Prakriti Vata-Pitta Prakriti 58.82% Manasika Prakriti Rajasika Prakriti 70.59% Sara Madhyama Sara 44.12% Samhanana Madhyama Samhanana 61.76% Satva Madhyama Satva 67.65% Abhyavaharana Shakti Madhyama 61.76% Vyayama Shakti Avara 47.05% Agni Mandagni and Vishamagni 26.47% Koshtha Krura 50% Chronicity 1-2 yrs 35.29% Onset Insidious 73.52% Family History Present 52.94% Treatment History Allopathic 50% 2. 3. Tagara Shankhpushpi

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Joshi Et Al; Efficacy Of Vachadi Compound (Kalpita Yoga) And Shirodhara By Ksheera In The Management Of Raktagata Vata W.S.R.To Hypertension

BMI

Obese

38.23%

Table 3: Showing improvement in Objective parameters after treatment Objective Parameters Group BTSD Mean ATSD 149.60 9.04 143.73 15.22 93.60 6.37 91.46 9.89 51.60 16.65 47.60 15.75 Mean Diff SEM % change t p S

Group I Systolic BP Group II

155.209.2 5 1566.71

5.60

1.03

3.69

5.40

<0.001

HS

12.26

3.05

7.86

4.01

<0.001

HS

Group I Diastolic BP Group II

95.865.73

2.26

0.70

2.36

3.23

<0.001

HS

97.337.50

5.86

1.59

6.02

3.68

<0.001

HS

Group I Pulse Pressure Group II

55.0617.5

3.46

0.83

6.28

4.13

<0.01

53.8615.9

6.26

2.83

11.23

2.21

<0.001

HS

Table 4: Showing improvement in symptoms of patients in trial SYMPTOMS n Shirashula(Headache) Hriddravata(Palpitations) Klama(Fatigue) Anidra(Insomnia/Disturbed sleep) Shvasakricchata(Breathlessness) Hritshula(Chest pain) Chinta(Anxiety) Bhrama(Dizziness) Sammoha(Confusion) 14 11 14 11 08 03 11 08 03 Group I % P change 53.33% <0.01 (60%) >0.05 (73.33%) >0.05 (33.33%) <0.01 (46.66%) (13.33%) (33.33%) (33.33%) (13.33%) >0.05 >0.05 <0.01 >0.05 >0.05 Group II % change p 08(53.33%) 06(40%) 08(53.33%) 09(60%) 02(13.33%) 02(13.33%) 07(46.66%) 04(26.66%) 01(6.66%) <0.001 <0.01 <0.001 <0.001 >0.05 >0.05 <0.01 >0.05 >0.05

Result N S NS NS S NS NS S NS NS 13 09 14 14 07 05 10 06 04

Result HS S HS HS NS NS S NS NS

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Joshi Et Al; Efficacy Of Vachadi Compound (Kalpita Yoga) And Shirodhara By Ksheera In The Management Of Raktagata Vata W.S.R.To Hypertension

Swedapravartana(Sweating) 12 (53.33) >0.05 NS 10 05(33.33%) >0.05 NS Krodha(Irritability) 11 (60%) >0.05 NS 12 06(40%) <0.01 S Table 5: Showing Overall effect on Systolic and Diastolic Blood Pressure Group I Group II Blood Pressure % improvement % improvement- % improvement- % improvement- Systolic BP Diastolic BP Systolic BP Diastolic BP Controlled 20.00% 33.33% 26.66% 33.33% Marked (>75%) 13.33% 13.33% 20.00% 13.33% Moderate (50-75%) 20.00% 06.66% 20.00% 13.33% Mild (25-50%) 13.33% 06.66% 13.33% 13.33% No Relief (<25%) 33.33% 40.00% 20.00% 26.66% No any significant results were found in lab parameters which mainly relate to the disease. DISCUSSION Probable mode of action of drug Constituents of the drug in the present study may have different pharmacodynamic properties due to which, multiple mechanism of actions taken place at different sites which may be responsible for disruption of pathogenesis of disease. Maximum ingredients of drug of Vachadi Compound have ushna virya predominantly. It mainly acts on vitiated vata dosha and thereby helps to alleviate the samprapti of disease. The drug having tikta rasa mainly along with deepana, pachana 5(Vacha, Punarnava) properties helps to alleviate obstruction in the strotasa due to ama by its digestion and thereby resulting into strotoshodhana and vatanulomana. The drug posseses tridoshahara 6(Tagara, Shankhpushpi) property by which etiopathogenesis of the disease may be broken at the level of tridosha, as in essential hypertension there is involvement of tridosha. Drugs may have destroyed strotorodha due to lekhana, medohara 7 (Vacha), deepana, anulomana8 (Punarnava) properties and normalize the

route of the vata in the strotasa.along with mutrala8 (Punarnava) property and 8 mutravishodhana (Vacha) property, thereby removing kleda in the body and also reduces cardiac volume. The significant result produced by Vachadi Compound may be due to its rasayana, medhya effect thereby producing anxiolytic, antistress, CNS depressant effect by inhibiting noradrenergic sympathetic nerves supplying to the heart. Through its deepana, pachana, lekhana, mutrala, vatanulomana properties it relieved strotorodha and digestion of ama and also decreased blood volume. Thus it may have contributed to decrease in blood pressure. The drug reduces vata-pitta dosha by its madhura vipaka and produces rasayana, medhya, nidrajanana effects. It probably induced sleep through its sedative, anxiolytic and depressant action on CNS. Drug alleviates raja dosha, by their manasdoshahara guna (Tagara, 9 Shankhpushpi) . The relief in shirshula may be due to raktadoshahara and 10 hirshadoshahara properties . Drug

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Joshi Et Al; Efficacy Of Vachadi Compound (Kalpita Yoga) And Shirodhara By Ksheera In The Management Of Raktagata Vata W.S.R.To Hypertension

contribute for the reduction of psychological factors like anxiety, stress etc. They also act as nervine tonic through their medhya, rasayana property. Probable mode of action of Shirodhara In shirodhara tactile impulses from the forehead by stimulating ophthalmic nerve may cause a somato-autonomic reflex and changes in levels of various neurotransmitters including serotonin, TRH, catecholamine resulting in sympathetic suppression and physioimmunologic changes of peripheral circulation and NK cell activityexhibits symptomatic effect. Kshiradhara by increasing tarpaka kapha, reduces vata-pitta and thereby relieves hriddravata through its anxiolytic, sedative and altered sense of consciousness inducing effects on brain. Shirodhara also improves circulation to hypothalamus and thereby improves function of Autonomic Nervous System. So that significant results were obtained in symptoms like klama and ati swedapravartana. Shirodhara increases tarpaka kapha, it acts as sedative and has soothing effect on brain and it induces sleep. That is reason to reduce anidra significantly in hypertensive patients. Ksheeradhara exerts its pacifying effects on sadhaka pitta and regulates function of hridaya. Thus it helps to alleviate irritability of mind. It can be said that shirodhara by acting on the hypothalamus regulates emotions and behavioural pattern resulting in decrease of most of the psychic and somatic disorders. Shirodhara facilitates function of kapha and thereby stablilzes the mana. Agnya Chakra is stimulated by shirodhara which improves

function of mind, vitiated in stress and anxiety. Shirodhara acts on structures like Pituitary gland, pineal body, sub cortical structure of mid-brain which are related with mental functions like memory, anger, grief, pain, fear and other higher intellectual functions and corrects their functions. In this way shirodhara is responsible for improvement in anxiety at significant levels. CONCLUSION Vachadi Compound and Ksheerdhara were found effective in reducing blood pressure of mild and mild plus moderate grade respectively and also alleviate the symptoms of essential hypertension without any adverse effects. Ksheerdhara reduced both systolic and diastolic pressure in a more pronounced way. Though maximum duration of Shirodhara is 21 days as per described in texts no any untoward side effect had been observed after its administration for 1 month. During the follow up study, it was found that there was rise in systolic and diastolic pressure suggesting the palliative nature of the treatment.The plus point observed in case of Ayurvedic management is absence of and hazardous effect, which is really a great benefit to the patient and is of vital importance in view of the global acceptance of Ayurveda. Further extensive study is needed to authenticate the results of the present study, with larger samples and more precise diagnostic and assessment criteria.

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Joshi Et Al; Efficacy Of Vachadi Compound (Kalpita Yoga) And Shirodhara By Ksheera In The Management Of Raktagata Vata W.S.R.To Hypertension

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1. Daniel G et al, Clinical Cardiology. 2. Harrison's Principles of Internal Medicine 17th edition published by Tata Mc.Graw Ltd, New Delhi .page no. 3. Oxford Textbook of Medicine, David Weatherall; Oxford University Press 2003.4th Ed. Page no. 4. Charaka Samhita Chikitsasthana 28/19, CHARAKA SAMHITA with Vidyotini Hindi commentary by Pt. Kashinath Shastry and Dr. Gorakhnath Chaturvedi, Part 1 and 2, Chaukhambha Bharati Academy, 1996. 5. Dhanvantari Nighantu by Z. Ojha, Adarsh Vidya Niketan Prakashan, 1985. 6. Bhavaprakash Nighantu of Shri Bhavamishra commentary by Dr. K.C. Chunekar, Chaukhambha Bharati Academy, 2002. 7. Ashtanga Hridaya of Vagbhata with the Nirmala Hindi commentary by Dr. Bramhanand Tripathi, Chaukhambha Sanskrit Prakashana, Delhi, Sutrasthana16/36 Vachadi Gana, reprint edition 2007. 8. Dravyagunavigyana Vol.II by Priyavrata Sharma, Chaukhamhba Bharati Academy,Varanasi, 2005 9. Priya Nighantu with Padmakhya Hindi commentary by Priyavrata Sharma, Chaukamba Surbharati Prakashana, Varanasi, 1983 10. Kaiydev Nighantu by Priyavrata Sharma, Chaukhambha Orientalia, Varanasi, 1979.

Corresponding Author: Dr. Joshi Ram Kishor Professor and Head, PG Dept. of Kayachikitsa, NIA, Jaipur-Rajasthan Source of support: Nil, Conflict of interest: None Declared

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