Protocol of an Observational Study Based on the Prevalence of Essential Hypertension in Different Types of Prakruti in Wardha City, India

Background: In 2000, 26.4% people of the society were suffering hypertension in the globe and around 29.2% are considered to have hypertension till 2025. Coronary Heart Disease, Stroke and other vascular disorders are the adverse effects of hypertension. Hypertension is taxonomically adjacent to UchchaRakta Tapa in Ayurveda. Prakrutiis the morphological, physiological, and psychological basic traits, manifested in the intrauterine life and is said to be unchangeable throughout life. Objectives: The present study aims to observe the Prevalence of Essential Hypertension in different types of Prakruti to differentiate Systolic blood pressure and Diastolic blood pressure according to various Prakruti in the population of Wardha city and contribute to knowledge in this population regarding Essential Hypertension and its relation with Prakruti. Materials and Methods: Wardha. Data collected in from the hypertensive patients in Wardha district by personal interviews based on the Prakruti Questionnaires. Study Protocol Bhatero et al.; JPRI, 33(36B): 161-166, 2021; Article no.JPRI.71211 162 Results: The results will be concluded on the basis of observations drawn from the collected information.


INTRODUCTION
Prakruti (Ayurvedic constitution) is a composed phenomenon of the morphological, physiological and psychological basic traits. It is manifested in the intra uterine life according to the Beeja (genetic) and Dosha (body humours viz. Tridosha) influence and is said to be unchangeable throughout life [1]. Ayurveda gives an utmost importance to personalized therapy under "Purusham Purusham Vikshya" (an individualized approach) principle. Genetic and intrauterine influences make, every individual a distinct entity. Hence, a person has the physiological and pathological variations accordingly. If individual is revealed to any impulse exhibit differently according to different Prakruti. The variability in resistance to diseases, different natural onset of the disease and diverse therapeutic responses needs to be explored from the point of view of Prakruti [2].
Due to defective way of life hypertension is called lifestyle disorder. Wrong dietic habits and stressful psychological conditions makes the person more vulnerable for its sustainable & complex nature. Hypertension is diagnosed when Systolic Pressure is over 140 mmHg and Diastolic Pressure is over 90 mm Hg [3]. The overall prevalence of hypertension is (26.6%, 29.8% and 25%) in world [4], in India [5], and Maharashtra [6] respectively. 20.6% is the total universality of Hypertension in Wardha District. Whereas universality of males is 21.8% and females is 19.8% [7]. About 57% of deaths in India are due to Hypertension and about 24% deaths are due to CHD and Stroke [8]. Disease and death both are a common fundamental characteristics of mortal life. The survey of this search to find out the feasible remedies always a part of human growth. HTN is asymptomatic, widespread, usually easily treatable, readily visible and leads to lethal complication. They are the important character responsible for cardiovascular disease [9]. Hypertension is the major reason for brain, renal and peripheral arteries disorders as a complication which if not treated on time may cause death [10,11]. Since hypertension is asymptomatic(85%), is it also called as silent killer [12]. As specific cause of hypertension is not known till now [13]. It is assumed that hypertension is caused due to genetic and environmental factors.
It is the commonest cardiovascular disorder, posing major public health challenge to the population in socioeconomic and epidemiological transition [14]. There are many factors like Madyapan, Lavan, Diwaswap, Krodha, Shramaand Nidanarthakar Roga [15] also increase its risk. A high fat diet and body mass index has a positive correlation and physical activity is negatively related to hypertension.

Rationale of the Study
Hypertension is the burning issue leading to multiple cardiac problems in current era of modernization. It is one among the most alarming health problems and is originated silently from faulty lifestyle & wrong dietic habits. Taking into account its global incidence, its control has become the need of the hour. The lifelong and palliative treatment of hypertension is offered in contemporary medical system. Although antihypertensive treatment reduces the risk of cardiovascular and renal disease, longterm use of antihypertensive drugs is associated with various side effects. Then, there is a need to avoid this side effects and complication.

Study Design
A cross-sectional observational study using survey strategy in the form questioner based on the personal interview of the individual meeting to eligibility criteria of the study. The primary aim of the study is to determine the prevalence of Hypertension in different Prakruti of individuals located in Wardha city. In addition, as secondary objectives are aimed to compare Prakruti wise elevated Blood Pressure in the predefined population and to create awareness in the population regarding Hypertension and its relation with Prakruti.

Setting
The study will be conducted at two hospitals named as Mahatma Gandhi Ayurved College, Hospital and Research Centre, Salod (H) and Acharya VinobaBhave Rural Hospital, Sawangi (Meghe), Wardha. Data will be collected by personal interviews and the assessment of Systolic and Diastolic Blood pressure. All the subjects will be personally interviewed based on the Prakruti questionnaire. Prakruti Questionnaires will help to identify the prevalence of Hypertension according to Prakruti.

Participants
Patients having Hypertension According to ICD-10 for essential (ICD-10 Criteria I10) between age group 30-60years, irrespective of gender and people interested to take part in the study. Hypertension is diagnosed when Systolic Pressure is over 140 mmHg and Diastolic Pressure is over 90 mmHg of the patients. Patients other than hypertension and people not interested to take part in the study will be excluded.

Recruitment
By using simple random sampling, all eligible participants will be informed in advance about the nature of the study and the required time for the completion of the questionnaire. Proper informed consent has taken from the patients in their known language (Marathi / Hindi /English). The participation of the patient will be voluntary and not any financial assistance will be given. The questionnaire will be filled by the intern students during the interview of the participants. All the essential information will be recorded like name, address, affiliation, phone number, and email address for further assistance, if required. If the participants have any questions regarding research or study, that will be answered by investigating researchers.

Data Collection
For the development of the Prakruti survey questionnaire, the literature search and review regarding Prakruti analysis was carried out, and depending upon that information the questionnaire was prepared. The answers will be recorded in the questionnaire by marking the appropriate answer with the help of intern students. The assessment of Systolic and Diastolic Blood Pressure will be recorded in a special structured case proforma. After completion of the survey procedure, the participants Prakruti will be analyzed, and concerning to their Prakruti the list of Do's and Don'ts (Ahar and Vihar) will be provided.

Sample Size
The overall prevalence of hypertension Wardha district is 20.6% according to Anchala R, et al. [16]. A sample size of 650 participants with complete questionnaires is required (95% confidence interval). Expecting a 10% incomplete questionnaire or technical difficulty, at least 600 participants will be surveyed to achieve the target of 600 complete questionnaires.

Data Extraction, Management, and Statistical Methods
Manual data entry will be done in an excel sheet from marked answers in the completed Prakruti questionnaire and case record form. All the data will be analyzed with the help of statistical experts by using the Chi-square test to assess the association between categorical variables and the relation between Prakruti and variation in Systolic and Diastolic Blood Pressure. In windows, SPSS software will be used for all statistical analysis.

RESULTS AND DISCUSSION
Highly increasing the alarming systemic illness such as Hypertension as a result of adoption of unwholesome diet is the major burning issue nowadays. The current established palliative treatment although reduces the risk of cardiovascular and renal disease, however it never alters the pathogenesis of the disease. Moreover, long-term use of antihypertensive drugs is associated with various contraindications and multiple side adverse effects. Therefore, it becomes imperative to search or plan specific Ayurvedic diet or lifestyle which will be wholesome for person with specific Prakriti to prevent or control this clinical entity. The disease Essential Hypertension (EHT) is neither described in Ayurveda Samhita nor in any Samgraha Granthas. Although, the exact etiology of hypertension is not clearly known, the observations reveal that it is a multi-factorial disease involving ecological, biological as well as genetic factors. To prevent the occurrence of this disease, some dietic as well as lifestyle modifications are necessary.
As Ayurveda which is the ancient and holistic science of life,it especially emphasizes over the specific & proper diet & Behavioural regime based on the type of predominance of the Dosha in basic constitution of the Person.
As genetic factors involved in generation of Hypertension and Prakrutiof every person remains constant from the birth. Moreover, Aahara(diet), Vihara(lifestyle) and Aushadhi(medication), which are the three pillars of Prakruti-based medicine, so observations related with that can be considered outstandingly in context of Hypertension. Therefore, Prakrutibased medicine, diet & lifestyle can play a vital role in changing this scenario of hypertension.
However, on assessing the present literature, there is no any published data regarding occurrence of hypertension based on Prakruti. Therefore, this study is planned in order to establish specific and suitable recommendations based on Prakruti for diet and lifestyle for hypertensive patients to lead a complications free therapy.
Hypertension is diagnosed when Systolic Pressure is over 140 mmHg and Diastolic Pressure is over 90 mmHg of the patients. By definition, observational studies have greater heterogeneity of medical interventions and patient populations that are closer to clinical practice. Observational studies is significant because it is economically affordable than RCT and can certainly be done which is less time consuming.
On extensive review of literature, it is observed that the person with TridoshajPrakruti and Vata Pradhan Prakrutiare highly vulnerable for getting hypertension in future due to involvement of VataDosha in the pathogenesis of hypertension. This statement is supported by Anil Avhad et. al. [17,18]. Few of the related studies on hypertension from modern medicine were reviewed [19][20][21]. Studies on Ghrelin use in heart failure [22] and effectiveness of Yoga [23] were reported.

CONCLUSIONS
The conclusion will be drawn based on the observations and result identified in the current study. The higher prevalence of hypertension is expected in Vata Predominent and Tridoshaj Prakruti. Therefore to attain and maintain good health, certain protocol of lifestyle based on the Prakruti in Ayurveda can be established through this observational study that may become a ray of hope of Hypertensive patients. It may provide newer approach to collate such guidelines which may helpful to attain complications free therapy in contemporary science with its optimum outcome.

CONSENT
Before the investigation and interview, the informed consent of the participants has taken.

ETHICAL APPROVAL
The cross-sectional survey conducted for six months for that approval has taken from the Institutional Ethical Committee IEC, Mahatma Gandhi Ayurved College, Hospital & Research Centre, Salod (H).