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A Study on Siddha Formulation Seedhobalathi Chooranam for Kuruthi Azhal Noi (Essential Hypertension)

Phase 2
Not yet recruiting
Conditions
Essential (primary) hypertension,
Registration Number
CTRI/2025/05/087168
Lead Sponsor
National Institute of Siddha
Brief Summary

**BACKGROUND:**

Siddha system of medicine provides rejuvenatehealth care based on the principles of panchaBootham. The Siddha medicines are broadly classified into 32 Internalmedicines & 32 External medicines which plays asignificant role in thetreatment & management of variousdisease.Hypertension is one of the major public health problems around theglobe and its prevalence is rapidly increasing among developing countries. It’s important to note  thatincrease in hypertension directly contribute on even more serious conditions like strokes, diabetes, heart diseases and renal impairment.Therefore management of  hypertension has become a biggest challenge in developing country like India. Hypertension, commonlyknown as high blood pressure definedwith standard criteriaas systolic BPgreater than or equal to 140 mmHg anddiastolic BP greater than or equal to 90 mmHg. Prevalence of hypertension inIndia is at alarming level and is estimated to account for 10.8% of all the deaths in the country.Lack of awareness is one of the major factorleads to increased prevalence of  hypertensionin India. Many people are not awareabout their hypertension condition,even in some cases the reason for death remainselusive as most of thetime person suffering from hypertension do not show any visiblesymptoms, remains normal and diagnosed only after appearance of cardio vascular disease or stroke.According to the global burdenof diseases estimate 2015, hypertension is a most important cause of mortality. It is estimated that, 57% and24% of stroke and coronary artery disease-related deaths respectively are due tohypertension.

In Siddha, variousbotanical species and their preparations have proven to be advantageous in themanagement of cardiovascular ailments. Multiple pieces of data exist thatdemonstrate the efficacy of different Siddha medications in treatingcardiovascular problems. The clinical trial indicates that marudham pattai iseffective in treating congestive heart failure, chronic stable angina, andhypertension. The marudham pattai tree and its components, such as arjunolicacid, exhibit a cardioprotective effect in rats by virtue of their antioxidantactivity . The alcoholic extract derived from the bulb of Allium ascalonicumdemonstrates a favourable impact on the proteolytic and hypocholesterolemicactivity in rabbits . The rhizome of Curcuma longa Linn, also known asturmeric, and its active compound curcumin, have demonstrated a hypolipidemicimpact, anti  atherosclerotic activity,and antithrombotic effect. Recent research have shown that natural componentseffectively inhibit, regulate, and impede key factors associated withcardiovascular disease, such as oxidative stress and inflammatory mediators.Medicinal herbs have been beneficial in treating individuals with congestiveheart failure, systolic hypertension, angina pectoris, atherosclerosis,cerebral insufficiency, and venous insufficiency..

**OBJECTIVE:****PRIMARY OBJECTIVE:**

To evaluate the clinical effectiveness of siddha formulation  ***Seedhobalathi Chooranam*** in the management of Essential hypertension (according to Joint Nationl Committee 8 guideliness) among the patients attending Ayothidoss Pandithar Hospital, National Institute of Siddha.

**SECONDARY OBJECTIVE:**

The Quality of life in patients with hypertension through SF-36             Questionnaire will be assessed before and after treatment.

**STUDY DESIGN:**

This is an interventional study of Non randomized sampling which will be carried out for 1 year in patients with Essential hypertension reporting at Ayothidoss Pandithar Hospital, National Institute of Siddha, Chennai – 600 047 with 30 participants as sample size. Participants with age 18 to 59 years of both sex, Participants with Stage 1 Hypertension according to JNC 8 guidelines will be included in this study. Participants with liver diseases, kidney disease, hematopoietic disease, malignant tumor, cardiac diseases,  cerebrovascular diseases, white collar hypertension, Pregnant women. Patient who are taking anti-hypertensive medication will been excluded in this study.

**OUTCOME:**

**PRIMARY OUTCOME:**

The changes in  systolic and diastolic blood pressure will be assessed  before and after treatment according to JNC 8  guidelines.

**SECONDARY OUTCOME:**

The quality of life in patients with hypertension through SF-36 questionnaire will be assessed before and after treatment.

**RESULTS AND DISCUSSION:**

The results will be statistically analyzed and reported.

**KEYWORDS:**Kuruthi azhal noi, Essential Hypertension, Seedhobalathi chooranam, Siddha Medicine.

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
30
Inclusion Criteria

Stage I Hypertension according to Joint National Committee 8 guidelines.

Exclusion Criteria
  • K/c/o liver diseases, kidney disease, hematopoietic disease, malignant tumor, cardiac diseases, cerebrovascular diseases, white collar hypertension.
  • Patients who are taking anti-hypertensive medication.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The changes in systolic and diastolic blood pressure will be assessed before and after treatment48 days
( according to JNC 8 guidelines).48 days
Secondary Outcome Measures
NameTimeMethod
The quality of life in patients with hypertension through SF-36 questionnaire will be assessedbefore and after treatment.

Trial Locations

Locations (1)

Ayothidoss Pandithar Hospital

🇮🇳

Kancheepuram, TAMIL NADU, India

Ayothidoss Pandithar Hospital
🇮🇳Kancheepuram, TAMIL NADU, India
Dr Pooja R M
Principal investigator
6369850332
poojarmsiddha@gmail.com

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