A Comparative Clinical Study To Evaluate the Efficacy of Uccha Raktachaphara Yog With And Without Brahmi Taildhara In Cases Of Stage-I Essential Hypertension

The Present Synopsis Entitled â€œA Comparative Clinical Study To Evaluate the Efficacy of Uccha Raktachaphara Yog With And Without Brahmi Taildhara In Cases Of Stage-I Essential Hypertension”

AIM OF STUDY-To establish the comparative efficacy of Uccha Raktachaphara Yog and Brahmi Taildhara in the cases of Stage-I Essential Hypertension.

OBJECTIVE-

Primary Objective-

To assess the efficacy of Uccha Raktachaphara Yog and Brahmi Taildhara in cases of StageI1 Essential Hypertension

Secondary Objective-

1 To get a better insight of the etiopathology of Hypertension in terms of Ayurveda.

2  To study the role of Shaman Chikitsa and Taildhara in the management of Stage-I Essential Hypertension.

3 To assess the side effects of drugs if any

PLAN OF STUDY For the purpose of clinical trial, the patient fulfilling the clinical criteria for diagnosis of Stage-1 Essential Hypertension will be randomly selected irrespective of their sex, caste , and religion from OPD of State Ayurvedic College and Hospital , Lucknow. A careful history, physical examination and necessary investigation will be performed as per Performa prepared for the present trial.

TYPE OF STUDY- Randomized, double armed, open label, phase-2 trial. RANDOMIZATION- Computer generated Random Table.

SAMPLE SIZE-Minimum 60 patient of Stage-1 Essential Hypertension from OPD of State Ayurvedic College, Lucknow and other referred patients will be selected according to the Inclusion and Exclusion criteria and randomly divided into two groups i.e.-Group A and Group B with approximately 10% drop out.

n = Z2PQ/e2

INCLUSION CRITERIA

1. Patients willing to sign the consent form for the clinical trial.

2. Patients of either sex or religion between age group (31-60 years).

3. Patients of Stage-I Essential Hypertension Up to Stage-1 of Hypertension according to JNC 8th criteria. Systolic B.P. -140-159 mmHg Diastolic B.P. - 90-99mmHg

4. Patients of Essential Hypertension with or without non essential criteria.

5. Patients having no known complication of associational disease.

6. Disease should be>3 months and <5years.

EXCLUSION CRITERIA

1. Patients of Essential Hypertension Stage-II according to JNC 8th criteria.

2. Patients of Malignant and Secondary Hypertension.

3. Hypertension with severe complications.

4. Pregnancy induced Hypertension.

5. Known case of Portal Hypertension.

6. Known case of Renal Disease.

7. Known case of Diabetes mellitus.

8. Known case of Cardiovascular Disorders.

9. Hypertension Encephalopathy.

10. Patients with endocrinal disorders.

11. History of drugs like oral contraceptive Pills, steroids, β-agonistic drugs.

12. Patients >31year and <60year will not be included.

GROUPING OF PATIENTS

Group A- Patients of group A will be advised Uccha Raktachaphara Yog orally with plain water.

Group B – Patients of group B will be advised Uccha Raktachaphara Yog orally with plain water along with Brahmi Taildhara.

Dosage and Duration –. Uccha Raktachaphara Yog will be given in doses of 2 capsules(500mg each) early morning (between 7-8 am irrespective of food) and evening (between 7-8 pm ) with plain water for 30 days in both groups A & B.

Concomitantly 5gm of Trivrita Churna will be given for Kostha Shudhi at bed time of with lukewarm water for 3-7 days as per the type of Kostha of patient in both groups.

Taildhara Time period- 60 min. per day during morning time.

Duration- Twice in a period of 1 month with a gap of 10 days.

PERIOD OF STUDY: Total duration of Clinical trial will be of 30 days.

FOLLOW UP PERIOD: Studies of all registered cases will be done at every 10 days interval for a period of 30 days with trial drug and Taildhara and 10 days without drug and Taildhara to access the condition of patients and to observe any other side effect.

DURING TREATMENT: D10 D20 D30

AFTER TREATMENT: 10 days without drug after the completion of trial.

CRITERIA FOR ASSESSMENT Data will be collected before, during and after completion of trial and will be subjective for analysis. All the essential and non essential criteria will be graded 0, 1, 2, 3 on the basis of its intensity & severity given by persons on complained & confirmed by clinical examination during the trial.

Essential Criteria

The assessment will be done by measuring blood pressure from standard well calibrated Sphygmomanometer of appropriate cuff size. JNC 8th classification of Hypertension will be followed. Using a sphygmomanometer, three consecutive readings of blood pressure will be taken in three different positions (sitting, standing, and supine) on both arms. The mean value will be calculated for each arm separately, and the highest reading will be used to diagnose and categorize the patients according to the 8th JNC Criteria of Hypertension. Only patients who are known cases of Stage-1 Essential Hypertension will be included in the study. Kortokoff sounds I and V will be used to determine systolic and diastolic blood pressure. On the basis of diastolic and systolic blood pressure, we will score the blood pressure reading as (based on JNC-8 th criteria)

Non-Essential Criteria

Data will be collected before, during and after completion of trial and will be subjective for analysis. All the signs & symptoms are graded 0, 1, 2, 3 on the basis of its intensity & severity given by persons on complained & confirmed by clinical examination before giving the trial drugs. The clinical improvement during & after trial drugs will also be correlated with previous intensity of the signs & symptoms if present.

Shiroruk

Spandan

Bhrama

Klama

Sweda

Krodhaprachurya

Stambha

TOTAL EFFECT OF THERAPY The total effect of therapy of this trial will be grouped as follows –

Marked Improvement

Improved

Unchanged

Worsened

1.Marked Improvement Patients having 76- 100% relief in term of clinical symptoms and blood pressure in normal range.

2.Improved Patients having 51- 75% relief in term of clinical symptoms and significant relief blood pressure.

3.Unchanged Patients having <50% relief in term of clinical symptoms and no significant relief in blood pressure.

4.Worsened Patients having increase in presenting clinical symptoms and no relief or rise in blood pressure.