India is the second most populous country in the world and emerging burden of the cardiovascular deaths (CVD) in the country is alarming.¹In 1990 CVD accounted for 20% of all deaths in this region.²Out of these coronary heart disease 60% and stroke 40% were responsible for it in. Currently 30% of all deaths that is almost 20 lakhs, are annually caused by CVD in India.^3,4High blood pressure or hypertension is among the major risk factors for increasing CVD in India.³

Until 1940, a majority of cardiovascular diseases were treated with traditional drugs obtained from plants, but with time, entry of conventional modern medicine has overshadowed the phytopharmaceutical products.^5,6 In lieu of the fact that the incidence of hypertension is still rising alarmingly, there is dire need to search for an effective and safe remedy because of lack of current therapies to either provide complete cure or treating the patients at the cost of adverse effects.^7,8

Ayurveda has no direct reference of blood pressure or hypertension in its classics. The term like hypertension was coined after the invention of Sphygmomanometer. According to Acharya Charaka, in case of an unknown disease, the physician should try to understand the nature of the disease through Dosha, the site of manifestation, etiological factors and then should initiate the treatment,⁹So, it becomes necessary to study the factors which are involved in hypertension and find the effective therapy for the same.

Hypertension if uncontrolled, may lead to several dreadful complications; stroke is one of those complications.¹⁰ In our hospital, Pakwasa Samanvaya Rugnalaya, most of the patients come for the treatment of stroke. Many of them are found to be suffering with hypertension. To treat hypertension a combination of ten herbs is used which is called as Shamak Yoga (SY) literally meaning, a combination which pacify the given condition. This combination was used to relieve anxiety, palpitation and insomnia.

SY is not described in Ayurvedic texts as a specific formulation but it is in use in Pakwasa hospital since more than 25 years. In an unpublished pilot study, Dr Shrikant Kashikar studied the effect of SY in anxiety. He found that it lowers the systolic blood pressure by 10 mmHg. In the light of this study it was decided to study the effect of Shamak Yoga (SY) on raised arterial blood pressure in comparison of Atenolol.

MATERIAL AND METHODS:

Study design-

Single blind prospective randomized control trial.

Intervention

Experiment Drug: -

Shamak Yoga:

It is a mixture of powders of root of Vacha (Acorus calamus), Shati (Hedychium spicatum), Tagar (Valeriana wallichii), Pushkarmool (Inula racemosa), fruit of Ela (Elettaria cardamomum), root of Ashwagandha (Withania somnifera), Panchang of Bramhi (Bacopa monnieri), Shankhapushpi (Convolvulus pluricaulis), root of Jatamansi (Nardostachys jatamansi) and Musta (Cyperus rotundus) in equal proportion. All of the above drugs were purchased from local vendor of repute. They were washed with tap water and dried in shelter. All the herbs were taken in equal proportion and grinded to fine powder form. This powder was sealed in opaque PVC packs of 2gm each.

Dosage:

2 gm twice a day Vyan and Udan Kala (After lunch and dinner) with plain water.

Control Drug:

Tablet Atenolol, it was purchased from generic medicine store.

Mode of administration:

Oral

Dosage:

50mg once a day after breakfast with plain water.

Duration of the Intervention:

4 weeks

Follow-up: -

Weekly; Day 0, 7^th, 14^th, 21^st and 28^th

Assessment Criteria:

Subjective Criteria:

Group A included tremors, tingling sensation, sense of weakness, blurred vision, burning micturition and heartburn. Group B included loss of appetite, Ghabarahat, dyspnea on exertion, nausea, vomiting, chest symptoms, edema and perspiration. Group C included headache, giddiness, fatigue, dizziness, sleeplessness, body ache and palpitation.

Objective Criteria:

1. Systolic blood pressure (Day 0, 7^th, 14^th, 21^st, and 28^th)

2. Diastolic blood pressure (Day 0, 7^th, 14^th, 21^st, and 28^th)

Blood pressure measurement:

To determine systolic and diastolic blood pressure the Korotkoff sound I and V was used.¹¹

Investigations:

Investigations were carried out to rule out secondary hypertension or any other pathologic condition. Hb%, TLC, DLC, ESR, BSL-F PP, urine examination, ECG and X ray chest PA view were done on Day 0 and 28^th.

34 patients were recruited; 20 patients in experimental group and 14 patients in control group were recruited randomly irrespective of sex, gender, cast, religion and socioeconomic status according to the inclusion criteria. Patients were examined according to the pro forma. Age, Sex, Aakriti, Deha Prakriti, Manas Prakriti, Agni, Koshtha, dietary habits, addiction and socioeconomic status were noted along with the symptoms present.

14 patients were studied in control group of Atenolol. 1 patient didn’t turn up for follow-up. 20 patients were studied in experimental group of SY.

RESULTS:

In this study maximum number of patients were from age group 41-70 years 26 out of 34(76.4%). 20 patients were males (58.8%). 58.8% were non vegetarians in their dietary habits. 19(55.8) patients were addicted to tobacco smoking, chewing or brushing. 9(26.4%) patients were addicted to alcohol. 16(47%) patients had Madhyam Akriti. 50% patients were of Vatapittaja Prakriti and 24 patients (70.5%) had Rajas Manas Prakriti. Majority of the patients, 41% were suffering with Mandagni. 50% patients had Kroora Koshtha.

The mean fall of systolic blood pressure in Experimental SY group was 15.8mmHg and 13.5mmHg in control group. The “t” vales for this fall are 10.2484 and 8.6153 respectively. Similarly in case of diastolic blood pressure, mean fall in SY group was 10.7 and 12.3077 in control group and “t” values are 8.2825 and 5.7660 resp. “P” for all these “t” values is less than 0.001, showing that the fall in systolic and diastolic blood pressure was statistically significant. Comparing these two groups and applying unpaired “t” test shows that “t” values are statistically insignificant. These observation show that experimental drug Shamak Yoga is effective and comparable with control drug Atenolol.

Hb%, TLC, DLC, blood sugar, urine examination, ECG and X ray chest did not show any significant changes after four weeks of therapy.

Table no. 1 Percentage of relief in symptoms –

	1^st week	2^nd week	3^rd week	4^th week
Group A symptoms
Atenolol	11.11	33.33	33.33	33.33
Shamak Yoga	22.03	31.18	40.54	42.42
Group B symptoms
Atenolol	30.43	33.33	55.55	55.55
Shamak Yoga	34.56	64.28	72.34	72.34
Group C symptoms
Atenolol	22	40.47	57.14	65
Shamak Yoga	37.5	64.28	73.17	82.92

Group A - tremors, tingling, Sense of weakness, Hyperacidity, blurring of vision and burning micturition

Group B - loss of appetite Ghabarahat, dyspnea on exertion, nausea, vomiting, chest symptoms, edema, and perspiration

Group C - headache, giddiness, fatigue, dizziness, sleeplessness, body ache and palpitation

The table no.1 shows that both Atenolol and SY are not much effective on symptoms of group A. Atenolol shows zero growth in recovery rate after second week whereas efficacy of SY is better with better recovery rate. After studying the group B symptoms, it is clear that initially effective Atenolol again showed zero growth in recovery rate after third week similar to SY but percentage of relief of symptoms with SY was one and half time more than that of Atenolol. Group C showed that both SY and Atenolol had best effect on these set of symptoms, maintaining the progressive trend of relief percentage throughout the duration of study. Here also SY showed better percentage of relief on these symptoms.

DISCUSSION:

Samprapti (Ayurvedic pathogenesis) of hypertension makes it clear that Kapha Prakopa and Aam Dosha cause Sanga or obstruction in the movement of Vata. Shamak Yoga’s drugs contains Tikta and Kashaya rasa with Ushna Virya, these properties are responsible for Kapha Shamana. Presentation of hypertension is very similar to Pittavritta Vata¹². Shamak Yoga contains Tikta, Kashay and Madhur Rasa, which pacifies Pitta. With the treatment of Aavaraka, aavritta Vata gets regularized causing control of hypertension. Vikrit karma of Pitta can be compared with dysfunctioning of endocrine syste¹³. We are well aware that angiotensin system and adrenal functions are some of the most important factors for maintaining arterial blood pressure¹⁴. Pitta shamana helps to regularize endocrine function. SY contains Brahmi, Shankhpushpi, Jatamansi, Tagar and Ashwagandha. These drugs have calming and anxiolytic effects^15-21, which help to control hypertension.

Majority of old age patients in the study proves the importance of Vata in hypertension. Asamyak Ahara and Vihar are also responsible for hypertension; this was evident in the study that most of the male patients had irregular routine and dietary habits^22,23. Patients taking Rajasik Ahara with spicy and high calorie food formed the major number of hypertensives in this study. Rajas Prakriti people with short temperament and aggressive nature were maximum in number. People with Vishamagni and Mandagni were more in number. Maximum patients had Kroora Koshtha in this study^24,25.

SY did not show any major side effects except drowsiness in two patients and mild body ache in a patient.

CONCLUSION:

SY was found comparable effective for systolic and diastolic blood pressure in mild hypertensive patients. SY is most effective on symptoms like headache, giddiness, fatigue, dizziness, sleeplessness, body ache and palpitation and moderately effective on included loss of appetite, Ghabarahat, dyspnea on exertion, nausea, vomiting, chest symptoms, edema and perspiration. SY is not effective on symptoms like tremors, tingling sensation, sense of weakness, blurred vision, burning micturition and heartburn.

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Received on 21.11.2020 Modified on 17.01.2021

Research J. Pharm. and Tech. 2021; 14(9):4925-4928.

DOI: 10.52711/0974-360X.2021.00856