An open labelled observational clinical trial to evaluate the combined effect of virechanottara bilwadhi kashaya basti in hrudroga wsr to coranary artery disease

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Coronary heart disease is a type of heart disease where the arteries of the heart cannot deliver enough oxygen-rich blood to the heart. This is due to the buildup of cholesterol and other material, on their inner walls called atherosclerosis. As a result, the heart muscle can’t get the blood or oxygen it needs. This can lead to chest pain (angina) or a heart attack1.

Coronary artery disease is the foremost single cause of mortality and loss of Disability Adjusted Life Years (DALYs) globally. In 2015 CAD accounted for 8.9 million deaths and 164.0 million DALYs2. In India in 2016, CVDs contributed to 28.1% of total deaths and14.1% of total disability-adjusted life years3.

Hrudroga is explained in various Ayurvedic texts. It occurs due to Pranavaha – Rasavaha srotodushti. The causative factor can be understood as agnimandya (poor metabolism) leading to ama which causes rasa dushti and that may lead to upalepatva (coating), sanga (obstruction) in rasavaha srotas (vessels) which hampers vyana vayu leading to Hrudroga4

Modern interventions for CAD include stenting and bypass surgery which are time taking, invasive and expensive. Ayurvedic line of management for Hrudroga include vamana5, virechana6 and basti7 etc. The treatments such as virechana and basti are the major shodhana procedures which cleanse the body by removing the ama (toxins) thereby clearing the margavarodha (obstruction) which helps in the treatment of disease condition.

So, in the present study Virechana followed by Bilwadi Kashaya Basti7 is undertaken. For Deepana-Pachana, Trikatu churna8 is advised and for Snehapana Bilwadi taila is used followed by Abhyanga with Murchitatila taila and Bashpa sweda. Danti haritaki9 is taken for Virechana. It is sukha virechaka and niratyaya mentioned by Acharya Charaka. As Hrudaya is one of the sadyapranahara marma10. Acharya Charaka has mentioned basti for marma paripalana11. Bilwadi kashaya basti helps to regulate the movement of vata dosha, strengthens and nourishes the cardiac muscle. To put forward effective strategies for management and treatment of CAD through ayurvedic treatment this study is undertaken.

Hence the present study entitled as **“AN OPEN LABELLED OBSERVATIONAL CLINICAL TRIAL TO EVALUATE THE COMBINED EFFECT OF VIRECHANOTTARA BILWADI KASHAYA BASTI IN HRUDROGA W.S.R TO CORONARY ARTERY DISEASE "**undertaken.

OBJECTIVES OF THE STUDY:

·       Clinical evaluation of the combined effect of Virechanottara Bilwadi Kashaya Basti in Hrudroga w.s.r to Coronary Artery Disease.

Ø ASSESSMENT CRITERIA:

 •        SUBJECTIVE PARAMETERS:

 1.     Hrutshoola ( Angina )

2.     Swasavarodha(Dyspnea)

3.     Hrudrava(Palpitation)

4.     Klama ( Fatigue)

5.     Sweda (Sweating)

1. Hrutshoola (Angina)

Canadian Cardiovascular Society grading of angina pectoris

Grade I

Ordinary physical activity does not cause angina, such as walking and climbing stairs.  Angina with strenuous or rapid or prolonged exertion at work or recreation

|Grade II

Slight limitation of ordinary activity.  Walking or climbing stairs rapidly, walking uphill, walking or stair climbing after meals, or in cold, or in wind, or under emotional stress, or only during the few hours after awakening.  Walking more than two blocks on the level and climbing more than one flight of ordinary stairs at a normal pace and in normal conditions

|Grade III

Marked limitation of ordinary physical activity.  Walking one or two blocks on the level and climbing one flight of stairs in normal conditions and at normal pace

|Grade IV

Inability to carry on any physical activity without discomfort, anginal syndrome may be present at rest

According to New York Heart Association

1. Swasavarodha (Dyspnea)

 

NYHA CLASS OF DYSPNEA

DEFINATION

|Grade I

Ordinary physical activity does not cause undue dyspnea.

|Grade II

Ordinary physical activity causes dyspnea.

|Grade III

Comfortable at rest; less than ordinary physical activity causes dyspnea.

|Grade IV

Symptoms occur at rest; any physical activity increases discomfort.

Hrudrava  (Palpitation)

NYHA CLASS OF PALPITATION

DEFINATION

|Grade I

Ordinary physical activity does not cause undue palpitations.

|Grade II

Ordinary physical activity causes palpitations.

|Grade III

Comfortable at rest; less than ordinary physical activity causes palpitations.

|Grade IV

Symptoms occur at rest; any physical activity increases discomfort.

Klama ( Fatigue)

NYHA CLASS OF FATIGUE

DEFINATION

|Grade I

Ordinary physical activity does not cause undue fatigue.

|Grade II

Ordinary physical activity causes fatigue.

|Grade III

Comfortable at rest; less than ordinary physical activity causes fatigue.

|Grade IV

Symptoms occur at rest; any physical activity increases discomfort.

Sweda (Sweating)

SWEATING CLASS

DESCRIPTION

|Grade I

No sweating present, even during physical activity or stress

|Grade II

Occasional sweating, typically during intense physical activity or under significant stress

|Grade III

Frequent sweating occuring during moderate physical activity or stressful situations.

|Grade IV

Profuse sweating occuring even at rest or with minimal physical activity, often accompanied by other symptoms such as shortness of breath or chest discomfort

OBJECTIVE PARAMETERS:

1. Lipid profile

Total serum cholesterol

Normal - < 200mg/dl

Borderline high – 200-239mg/dl

High - >240mg/dl

|Low density lipoprotein

Normal -100-130mg/dl

Mild -130-159mg/dl

Moderate-160-189mg/dl

Severe - > 189mg/dl

|Triglycerides

Normal < 150mg/dl

Mild – 150- 499mg/dl

Moderate- 500-886mg/dl

Severe > 886mg/dl

High density lipoprotein

Low range -< 40mg/dl

High protective range > 60mg/dl

                                       Ejection Fraction

The simplest classification as per the American College Of Cardiology (ACC) that is used clinically as follows:

Hyper dynamic

LVEF greater than 70%

|Normal

LVEF 50% to 70%

|Mild dysfunction

LVEF 40% to 49%

|Moderate dysfunction

LVEF 30% to 39%

|Severe dysfunction

LVEF less than 30%

  Blood pressure: Recommended by American Heart Association

Blood pressure category

Systolic mm hg

Diastolic mm hg

|Normal

Less than 120

Less than 80

|Elevated

120 - 129

Less than 80

|High blood pressure (Hypertension) stage 1

130 - 139

80 - 89

|High blood pressure (Hypertension) stage 2

140 or higher

90 or higher

|Hypertension crisis

Higher than 180

Higher than 120

                                           

Ø  OVERALL ASSESSMENT:

·       Marked relief-above 75% improvement.

·       Moderate relief-50%-75% improvement.

·       Good relief -25% -50% improvement.

·        Mild relief - below 25% improvement.

·       No relief – 0%

Ø  OVERALL ASSESSMENT:

·       Marked relief-above 75% improvement.

·       Moderate relief-50%-75% improvement.

·       Good relief -25% -50% improvement.

·        Mild relief - below 25% improvement.

·       No relief – 0%