A clinical study on the effect of Triphaladi Kala Basti with Arjuna Punarnavadi Ghanavati in the management of essential hypertension.

INTRODUCTION: Hypertension, one of the grave conditions, accounts for 6% of deaths worldwide. In 2010 increased blood pressure was the cause of an estimated 9.4 million deaths. According to Ayurveda, systemic arterial hypertension can be considered as Tridoshaja condition with predominance of Vata and Pitta along with invovment of Rasa, Rakta and Meda. Basti Karma a medicated enema procedure is the best treatment for vitiated Vata Dosha and it regulates the movement of Vata Dosha.
OBJECTIVES: The present study was conducted to evaluate effect of Triphaladi Kala Basti procedure given along with Arjuna Punarnavadi Ghanavati in the management of essential hypertension.
MATERIALS AND METHODS: Fifteen patients who were diagnosed cases of essential hypertension as per the 7th JNC and World Health Organization criteria for diagnosis of hypertension were treated with Triphaladi Basti followed by oral administration of Arjuna Punarnavadi Ghanavati.
RESULTS: Administration of Basti and Arjuna Punarnavadi Ghanavati were effective in reducing both systolic and diastolic blood pressure level which was highly significant (P < 0.001).
CONCLUSION: Triphaladi Kala Basti procedure along with oral administration of Arjuna Punarnavadi Ghanavati is moderatly effective in management of systemic arterial hypertension.

Introduction

Systemic arterial hypertension is resultant of prolonged and excess of stress caused by blood on the wall of arteries. It is an elevated arterial pressure level >140/90 mmHg. Essential hypertension affects 90%–95% of hypertensive patients. It has been estimated that hypertension accounts for 6% of deaths worldwide.[1] The most devastating aspect of this disorder is that it is not characterized by any of the cardinal symptoms and causes damage to vital organ over a period. Persistent hypertension doubles the risk of cardiovascular disease, including coronary heart disease, ischemic and hemorrhagic stroke and renal failure.[1] The National Health and Nutrition Examination Survey reported that about 16 million hypertensive patients take medicine, but still do not have their blood pressure under control. In 2010 increased blood pressure was the cause of an estimated 9.4 million deaths.

Although antihypertensive therapy clearly reduces the risk of cardiovascular and renal disease, long-term use of antihypertensive drugs is associated with adverse effects.[2]

According to Ayurveda hypertension is caused by vitiation of Tridosha specially Vata-Pitta. Ayurveda through its holistic approach and radical treatment like Panchakarma, corrects basic pathology by eliminating chief causative factors. Basti Karma (medicated enema procedure) is choice of treatment for vitiated Vata Dosha. Basti Karma regulates the activity and movement of Vata. Thus, with this thought, Basti Karma with Sroto-Shodhaka (macro & micro channels cleanser) drug like Triphala was selected for study followed by oral administration of Arjuna-Punarnavadi formulation.

Aims and objectives

The present study was planned to evaluate the effect of Triphaladi Kala Basti procedure and oral administration of Arjuna Punarnavadi Ghanavati in the management of essential hypertension.

Materials and Methods

Fifteen patients were selected from out-patient department and IPD of Panchakarma, National Institute of Ayurveda, Jaipur, who were diagnosed as cases of essential systemic arterial hypertension as per the 7th JNC and World Health Organization (WHO) criteria for diagnosis of hypertension. The study was approved from Institutional Ethics Committee (registration no. RAU/ACa/622/12-13), Dr. Sarvepalli Radhakrishnana Rajasthan Ayurved University, Jodhapur.

Inclusion criteria

Patients of either sex from the age group 20 and 60 years

Patients who were diagnosed cases of essential hypertension were selected

Patients of stage 1 hypertension, stage 2 hypertension, isolated systolic hypertension as per the 7th JNC and WHO criteria were included [Table 1]

Table 1

7th Joint National Committee and WHO criteria for diagnosis hypertension (HTN)

Category of HTN	Systolic BP (mmHg)	Diastolic BP (mmHg)
Normal	<120	And <80
Prehypertension	120-139	Or 80-89
Stage 1 hypertension	140-159	Or 90-99
Stage 2 hypertension	≥160	Or ≥100
Isolated systolic hypertension	≥140	And <90

HTN: Hypertension, BP: Blood pressure

Patients fit for clinical trial.

Exclusion criteria

Secondary hypertension

Pregnancy-induced hypertension

Patients on oral contraceptive pills, steroids

Patients associated with serious illness such as malignancy, HIV and tuberculosis.

Criteria for assessment

Subjective parameters

Shirahshoola (headache)

Bhrama (giddiness)

Klama (fatigue)

Hritdravata (palpitation)

Swedadhikyata (excessive sweating)

Anidra (insomnia).

Assessment of above subjective parameters was done according to grading pattern [Table 2].

Table 2

The scoring pattern of subjective parameters

Parameters	Applied condition	Score
Shirahshool (headache)	Nil	0
	Rarely headache, relieves without medication	1
	Frequently headache relives by rest, does not disturb daily activities	2
	Frequently severe headache disturbs daily activities requires medication	3
	Continuous/severe headache disturbs sleep and daily activities and also not managed by the medication	4
Bhrama (giddiness)	Nil	0
	Rarely Bhrama for some moment during change of posture	1
	Often for few seconds during change of posture	2
	Often, even in lying condition also	3
	Patient unable to hold himself without any support	4
Klama (fatigue)	Nil	0
	Rarely feeling of tiredness without any exertion	1
	Rarely feeling of tiredness without any exertion with inability in concentration	2
	Frequently feeling of tiredness without any exertion with inability in concentration	3
	Continuous feeling of tiredness without any exertion with inability in concentration
Swedadhikyata (excessive sweating)	Able to do both routine and special activities without discomfort	0
	Mild sweating by heavy work	1
	Sweating with moderate work relieves soon	2
	Severe sweating with moderate work	3
	Severe sweating with mild work	4
Hritdravata (palpitation)	No palpitation	0
	Palpitation occasionally	1
	Palpitation sometime	2
	Palpitation frequently	3
	Palpitation almost common	4
	Palpitation at rest	5
Anidra (insomnia)	Sound sleep	0
	Disturbed sleep (wake up 1-2 times a night)	1
	Difficult to onset sleep remains disturbed in night	2
	Very less sleep for small intervals, makes patient irritable	3
	Not getting sleep without medicine	4

Objective parameters

Change in both systolic and diastolic blood pressure level in supine position before treatment and after treatment was assesed.

Patient consent

The treatment procedure with its different steps and the outcome was properly explained in detail to the patients. Written consent from the patient was obtained before enrolling them in the clinical study.

Treatment protocol

Basti procedure

Triphala oil Anuwasana Basti (60 ml) and Triphala decoction Niruha Basti (Triphala decoction (240 ml), honey (80 ml), Saindhava Lavana (rock salt) (5 g), Triphala oil (120 ml), Shatapushpa powder [30 g]).

Basti was administered as Kala Basti schedule:

A – Anuwasana Basti

N – Niruha Basti.

Preparation of the patient

On each day, patients were subjected to whole body massage with Dashamoola oil for 25–30 min followed by whole body mild fomentation for 5–10 min for 16 days. Dashamoola decoction was used for Swedana. After recording the vitals, the patients were advised to lie comfortably in the left lateral position on table.

Preperation of Basti Dravya

Anuvasana Basti

60 ml of lukewarm Triphala oil with Shatapushpa powder and rock salt (Saindhava Lavana) (each 1 g) filled into enema syringe fitted with rubber catheter (no. 08).

Niruha Basti

Honey (80 ml) was taken in round bottom bowl. To this rock salt (Saindhava Lavana) (5 g) was added and mixed well with the help of mortar till sound disappears. Then, lukewarm Triphala oil (120 ml) was poured in to it slowly with continuous trituration till homogenous mixture was formed. Shatapushpa powder (30 g) was taken in one bowl and Kalka (paste) was prepared using Triphala decoction, this was added slowly and mixed properly. later on, lukewarm Triphala decoction (240 ml) was added to it little by little and stirred well to get homogenous mixture. This was filtered and made lukewarm by heating indirectly in hot water bath, then poured into Basti Putaka [i.e. polythene bag tied to Basti Netra (cannula of this apparatus)].

Method of administration of Basti Dravya

Anuvasana Basti

The anal orifice and the tip of the catheter were lubricated with oil and after removing the air from the syringe and the catheter, the catheter was introduced into the anus gently up to 3 Angula (fingers) and the piston of the syringe was pressed slowly with uniform force and the oil was pushed into the rectum. The patient was asked to take deep breath and not to shake his body while catheter was introduced.

Then, the patient was advised to lie down in the supine position with hand and legs freely spread over the table. Thereafter, the legs of the patient were raised for three times; the buttocks were gently tapped, simultaneously taps were given on the soles and palm also.

Oil was smeared over Basti Netra (cannula of enema apparatus) and to the anal orifice, slowly Basti Netra was inserted inside the anal orifice in the direction of vertebral column till the first Karnika (mark) touches the anus. The patient was asked to take deep breath and then Basti Dravya (medicated oil or decoction for enema) was pushed with gentle pressure without shaking the hands. After that slowly Basti Netra was taken out and patient was asked lie down in supine position till he feels urge for defecation.

The observations such as time of administration of Basti Dravya, time of expulsion and Samyak Lakshana (symptoms of proper administration of enema), Vyapada (complication) if any and vitals were noted on each day. Patients were advised to take lukewarm water, avoid heavy and oily foodstuffs and suppression of natural urges, excess traveling or, exercise for one month after completion of Basti procedure.

Arjuna Punarnavadi Ghanavati

After Basti procedure Arjuna Punarnavadi Ghanavati 2 tablets twice a day was administered (each tablet of 500 mg) for 30 days. Then, follow-up of the patients was done weekly up to 1 month. Patients were not taking any other of medicine during follow-up period.

Observations and results

Maximum 60% of patients were from the age group of 41–50 years, 66.66% were female, 86.66% were married, 86.66% were of Hindu religion, 46.66% were graduate, 73.33% were from middle class, 86.66% were having Mandagni (reduced appetite), 73.33% were having Madhyama Koshtha (normal bowel habit), 46.66% belonged to Vata Kapha constitution, 53.33% patients were taking sweets and 60% patients were having addiction to tea.

Data related to disease

53.33% of patients were not having the positive family history, 60% patients were having chronicity of the disease between 4-10 years. 80% of patients were having history of day sleep, 26.66% of patients were having history of anxiety and stress, 66.66% of patient were taking antihypertensive drugs regularly and 26.66% of patients were not taking any antihypertensive medicine.

Data related to treatment

After administration of Anuwasana Basti, 93.33% of patients passed oil with stool and 86.66% patients attained Indriya Prasadana (improved perception and function of organs of body). Signs of properly conducted procedure of Niruha Basti (such as Prasrushta Vita, Mootra, Sameerana proper evacuation of bowel and improved urine output) was observed in 100% patients, Agni Dipti (increased appetite) in 100% patient and lightness in the body in 80% of the patients. Complains of headache and loose motion were observed in 6.66% and 20% of patients, respectively.

The data obtained in clinical study was subjected to statistical tests and was analyzed in two parts:

Objective parameters

Subjective parameters

Statistical analysis

Student paired t-test (two-tailed, dependent) was used to find the changes in objective parameters

Wilcoxon test was applied for the assessment of subjective parameter before treatment and after the treatment.

Results

The mean value of systolic blood pressure before administration of Basti was 154 mmHg which was reduced to 132.14 mmHg after completion of Basti procedure and it was maintained up to 132 mmHg after oral administration of Arjuna Punarnavadi Ghanavati which was statistically highly significant. Basti procedure was highly effective in reducing both systolic and diastolic blood pressure which was statistically highly significant (P < 0.001). After oral administration of Arjuna Punarnavadi Ghanvati blood pressure was maintained within normal range which was statistically highly significant (P < 0.0001). The mean value of diastolic blood pressure before treatment was 102 mmHg which was reduced to 85.33 mmHg after Basti procedure, with 16.34% of relief which was statistically highly significance (P < 0.0001). After oral administration of Arjuna Punarnavadi Ghanavati, the mean value of diastolic blood pressure, became 87.33 with 14.37% of reduction, on follow-up diastolic blood pressure maintained on 87.33 with same 14.37% of relief [Tables 3 and 4].

Table 3

Effect of Basti procedure on chief complains (Wilcoxon match paired signed rank test)

Chief complain	BT	After administration of Basti	Mean diff	Percentage relief	SD	SE	w	P
		After oral administration of Arj.Pun.Vati
Hritdravata (palpitation)	2.533	1.600	0.9333	36.84	0.5936	0.1533	78	0.0005
		0.8000	1.733	68.41	0.7988	0.2063	120	<0.0001
Bhrama (giddiness)	1.867	1.133	0.7333	39.27	0.4577	0.1182	66	0.0010
		0.7333	1.133	60.68	0.5164	0.1333	105	0.0001
Klama (fatigue)	1.733	1.067	0.6667	38.47	0.4880	0.1260	55	0.0020
		0.8667	0.8667	50.01	0.5164	0.1333	78	0.0005
Shirahshoola (headache)	1.333	0.6667	0.6667	50.01	0.4880	0.1260	55	0.0020
		0.4667	0.8667	65.01	0.6399	0.1652	66	0.0010
Anidra (insomnia)	1.467	0.8667	0.6000	40.89	0.5071	0.1309	45	0.0039
		0.4000	1.067	72.73	0.5936	0.1533	91	0.0002
Swedadhikyata (excessive sweating)	1.267	0.8667	0.4000	31.57	0.5071	0.1309	21	0.0313
		0.4000	0.8667	68.40	0.6399	0.1652	66	0.0010

Arj. Pun. Vati: Arjuna Punarnavadi Ghanavati, BT: Before treatment, SD: Standard deviation, SE: Standard error

Table 4

Effect of Basti procedure on systolic and diastolic blood pressure (paired t-test)

BP	Mean BP (mmHg)		Mean difference	Percentage relief	SD	SE	t	P
	BT	After administration of Basti
		After oral administration of Arj. Pun. Vati
		Follow-up
Systolic blood pressure	154.00	132.14	20.714	13.45	16.723	4.470	6.792	<0.0001
		132.00	22.000	14.28	16.125	4.163	5.284	0.0001
		135.33	18.667	12.12	18.465	4.768	3.915	0.0016
Diastolic blood pressure	102	85.333	16.667	16.34	8.997	2.323	7.174	<0.0001
		87.333	14.667	14.37	11.872	3.065	4.785	0.0001
		87.333	14.667	14.37	12.459	3.217	4.559	0.0004

Arj.Pun. Vati: Arjuna Punarnavadi Ghanavati, BP: Blood pressure, SD: Standard deviation, SE: Standard error, BT: Before treatment

Discussion

Hypertension may be considered as Tridoshaja Vyadhi with the dominance of Pitta and Vata Dosha, Dushti of Rasa (plasma), Rakta (blood) and Meda (fat) with Srotorodha (obstruction in channels) and Sirashaithilya (tortuous of veins). Among Panchakarma treatment, Basti procedure is the best treatment for correction of Vata Dosha. Basti procedure, though it is considered as the best remedy for morbid Vata, it is advised even for the treatment of Pitta Dosha, Kapha Dosha and Sarvadhatu Ashrita Vyadhi (systemic disorder).[3] Using various combinations of ingredients, it is considered good even in other Dosha, Koshtha (ablomin) and Marma (vital parts of body), Asthi and Sandhi Ashrita (incumbent on bones & joints).

Thus, after treatment the cleansing effect of Basti in the colon may have its effect all over the body in general and in particular on circulatory system. Thus, Basti procedure with drug Triphala having Lekhana (scraping), Srotoshodhaka (body channals cleanser) and Rakta-Pittashodhaka (blood purifier) property might have helped to reduce the blood pressure.

In hypertension or in the complications of hypertension, there is involvement of vital organs such as brain, heart and kidney, Arjuna Punarnavadi Ghanavati contains herbs which are organ specific and basically Rasayana (rejuvenating), Medhya (brain tonic), Mutrala (diuretic), Deepana (appetizer) and Hridya (cardiac tonic) in nature provided better and long-lasting relief.

Shamana drug

Arjuna Punarnavadi Ghanavati was prepared using Arjuna (Terminelia arjuna Roxb.ex DC.), Punarnava (Boerhaavia diffusa Linn.), Guduchi (Tinospora cordifolia (Willd.) Miers ex Hook. f. et Th.), Gokshura (Tribulus teerestris Linn.), Shankhapuhspi (Convonvulus pluricaulis Chois.), Draksha (Vitis vinifera Linn.), Haritaki (Terminelia chebula Retz.), Pushkarmoola (Inula resimosa Hook.f.) and Shunthi (Zingiber officinale Roscoe.) The purpose behind taking this Shamana Yoga (palliative treatment) is to alleviate remaining Doshas after Shoddhana (detoxification of body).

Arjuna possess Hridya (cardiotonic) property. Guduchi is the drug known for its pacifying tendency against vitiated Vata-Pitta and rejuvenating property. Recent research work on Guduchi had proved that it repairs the damaged cells of body. The most important biological properties of Guduchi reported are antioxidant, anti-diabetic, anti-inflammatory, anti-arthritic, anti-stress, hepatoprotective, immunomodulatory and anti-neoplastic activities.[4] Shankhapushpi is nootropic and neuro-tonic property. Convolvulus pluricaulis (The chloroform fraction of the total ethanolic extract) elicited a significant antidepressant-like effect in mice by interaction with the adrenergic, dopaminergic and serotonergic systems.[5] Hritaki is Tridoshahara, It is mild laxative, study was done on aqueous extract of Terminalia cheubla, showed that it inhibits the development of age-induced damages by protecting against oxidative stress.[6] Shunthi is anti-inflammatory and is used in cardiac pain. Recent study on Zingiber officinalis, in spontaneously hypertensive rats, showed that it reduces systolic blood pressure, atherogenic index and triglyceride levels, more potent in reversing endothelial dysfunction while was devoid of cardiac stimulatory effect.[7]

Punarnava

Research on Boerhavia diffusa reveals that, this medicinal plant might be potent and novel therapeutic agents for scavenging of NO and the regulation of pathological conditions caused by excessive generation of NO and its oxidation product, peroxynitrite, NO damages endothelial layer of arteries which leads to high blood pressure, B. diffusa helps to inhibit damage to arteries and thus reduces blood pressure.[8]

Conclusion

Hypertension is Tridoshaja Vyadhi with the dominance of Pitta and Vata Dosha. The cleansing effect of Basti in the colon may have its effect all over the body in general and in particular on the circulatory channel system which may help to reduce blood pressure and oral administration of Arjuna Punarnavadi Ghanavati contains drugs which are basically Rasayana (rejuvenating), Medhya (brain tonic), Mutrala (diuretic), Deepana (appetizer) and Hridya (cardiac tonic) in nature and thus also help to maintain blood pressure level. Thus it can be concluded that. Triphaladi Kala Basti procedure with Arjuna Punarnavadi Ghanavati is moderately effective in the management of essential hypertension.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.