Randomized Controlled Trial of Dhanyaka hima as an Add-on Therapy in Vyanbala Vaisamya with special to Essential hypertension

Title  Randomized Controlled Trial On Dhanyaka hima as an Add-on Therapy in Vyanbala Vaisamya with special reference to Essential hypertension.

Aim

To study the effect of Dhanyaka Hima as an Add-on Therapy in Essential Hypertension

. Primary Objectives:- To study the effect of Dhanyak Hima as an Add-on Therapy in Essential Hypertension.

Secondary Objectives:- 1) To prepare Dhanyak hima

2. to study the literature about hypertension according to Ayurveda & Modern Sciences.

3. To study the literature of Dhanyaka in Modern Science and Ayurved

Study design: A open label, parallel superiority Randomized Controlled Trial Screening of the subjects from population will be done on the basis of Inclusive criteria and exclusive criteria.

They will be divided into two groups randomly by computerised random sampling method after taking consent.

Group A ( Trial ) 50 individuals will be given Dhanyaka Hima along with anti hypertensive medication for 60 days

Group B (Control) 50 individuals will be only given anti hypertensive medication for 60 days

Then assessment will be done by objective parameters before and after study and subjective parameters

OnD-0, D-15,D-30,D-45 and D- 60 Statistical analysis with appropriate test and interpretation will be done

. Observation and Result Discussion Conclusion Duration of Treatment: 60 days Ethical Clearance: Clearance from Institutional Ethics Committee. 7.2

Study setting (location): 7.3 Duration of Study: The study will be conducted in our hospital and its periphery.

18 months after approval of synopsis 10 11 7.4 Type of study: 7.5 Sample Size: 7.6 Sampling Method:

A open label, parallel superiority Randomized Controlled Trial Study population:

On the basis of clinical examination and history, Total individuals will be selected according to their eligibility criteria.

Group A- 50 Individuals will be given Dhanyak Hima along with anti-hypertensive medication daily

Group B- 50 Individuals will be given only anti hypertensive medication daily

Inclusion criteria: 1. Age Group – 25- 60 years. 2. Irrespective of sex, education, religion and socio-economic status. 3. Patients having BP 130/80 mm Hg to 160/100 mm Hg [acc to IHA Guidelines] . 4.Patients who are taking anti hypertensive medication Exclusion criteria: 1. Patients having systemic serious complications of CVS, Renal system DM-type 2,Hyperlipidemia,Myocardial Infarction,Ischemic Heart Disease 2 Patients having abnormal ECG Values 3. Malignancy and pregnant women 4. If Patient is taking anti-hypertensive medication Withdrawal criteria: • If the selected patient who will not follow treatment protocol and instruction properly,will be conducted as dropout from study • Subject who unable to give follow up.