CTRI Number |
CTRI/2025/05/087168 [Registered on: 20/05/2025] Trial Registered Prospectively |
Last Modified On: |
15/04/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Siddha |
Study Design |
Single Arm Study |
Public Title of Study
|
A Study on Siddha Formulation Seedhobalathi Chooranam for Kuruthi Azhal Noi (Essential Hypertension) |
Scientific Title of Study
|
Clinical Evaluation of Siddha Formulation Seedhobalathi Chooranam in the Management of Kuruthi Azhal Noi (Essential Hypertension) Among the Patients Attending Ayothidoss Pandithar Hospital, National Institute of Siddha |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Pooja R M |
Designation |
PG Scholar |
Affiliation |
National institute of siddha |
Address |
Room no 7/8,Department of Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai
Kancheepuram TAMIL NADU 600047 India |
Phone |
6369850332 |
Fax |
|
Email |
poojarmsiddha@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr H Vetha Merlin Kumar |
Designation |
Professor |
Affiliation |
National institute of siddha |
Address |
Room no 7/8,Department of Maruthuvam, National Institute of
Siddha, Tambaram Sanatorium, Chennai
Kancheepuram TAMIL NADU 600047 India |
Phone |
9894782366 |
Fax |
|
Email |
dr.vetha@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr H Vetha Merlin Kumar |
Designation |
Professor |
Affiliation |
National institute of siddha |
Address |
Room no 7/8,Department of Maruthuvam, National Institute of
Siddha, Tambaram Sanatorium, Chennai
TAMIL NADU 600047 India |
Phone |
9894782366 |
Fax |
|
Email |
dr.vetha@gmail.com |
|
Source of Monetary or Material Support
|
National Institute of Siddha, Tambaram Sanatorium,Chennai-47 |
|
Primary Sponsor
|
Name |
National Institute of Siddha |
Address |
Room no 7/8, Department of Maruthuvam, National Institute of
Siddha, Tambaram Sanatorium, Chennai-47
|
Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Pooja R M |
Ayothidoss Pandithar Hospital |
Department of Maruthuvam,
National Institute of Siddha,
Tambaram Sanatorium,
Chennai-600047
Kancheepuram TAMIL NADU |
6369850332
poojarmsiddha@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTIONAL ETHICS COMMITTEE NATIONAL INSTITUTE OF SIDDHA CHENNAI - 600 047 |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
NIL |
NIL |
Intervention |
Seedhobalathi Chooranam |
3 grams of Seedhobalathi Chooranam with milk twice a day after food for 48 days. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
59.00 Year(s) |
Gender |
Both |
Details |
Stage I Hypertension according to Joint National
Committee 8 guidelines |
|
ExclusionCriteria |
Details |
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 |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
The changes in systolic and diastolic blood pressure will be assessed before and after treatment
( according to JNC 8 guidelines). |
48 days |
|
Secondary Outcome
|
Outcome |
TimePoints |
The quality of life in patients with hypertension through SF-36 questionnaire will be assessed
before and after treatment. |
48 days |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
Phase 2 |
Date of First Enrollment (India)
|
03/07/2025 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
N/A |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
BACKGROUND: Siddha system of medicine provides rejuvenate
health care based on the principles of pancha
Bootham. The Siddha medicines are broadly classified into 32 Internal
medicines & 32 External medicines which plays a
significant role in the
treatment & management of various
disease.Hypertension is one of the major public health problems around the
globe and its prevalence is rapidly increasing among developing countries. It’s important to note that
increase 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, commonly
known as high blood pressure defined
with standard criteria
as systolic BPgreater than or equal to 140 mmHg and
diastolic BP greater than or equal to 90 mmHg. Prevalence of hypertension in
India 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 factor
leads to increased prevalence of hypertension
in India. Many people are not aware
about their hypertension condition,even in some cases the reason for death remains
elusive as most of the
time person suffering from hypertension do not show any visible
symptoms, remains normal and diagnosed only after appearance of cardio vascular disease or stroke.According to the global burden
of diseases estimate 2015, hypertension is a most important cause of mortality. It is estimated that, 57% and
24% of stroke and coronary artery disease-related deaths respectively are due to
hypertension.
In Siddha, various
botanical species and their preparations have proven to be advantageous in the
management of cardiovascular ailments. Multiple pieces of data exist that
demonstrate the efficacy of different Siddha medications in treating
cardiovascular problems. The clinical trial indicates that marudham pattai is
effective in treating congestive heart failure, chronic stable angina, and
hypertension. The marudham pattai tree and its components, such as arjunolic
acid, exhibit a cardioprotective effect in rats by virtue of their antioxidant
activity . The alcoholic extract derived from the bulb of Allium ascalonicum
demonstrates a favourable impact on the proteolytic and hypocholesterolemic
activity in rabbits . The rhizome of Curcuma longa Linn, also known as
turmeric, and its active compound curcumin, have demonstrated a hypolipidemic
impact, anti atherosclerotic activity,
and antithrombotic effect. Recent research have shown that natural components
effectively inhibit, regulate, and impede key factors associated with
cardiovascular disease, such as oxidative stress and inflammatory mediators.
Medicinal herbs have been beneficial in treating individuals with congestive
heart 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.
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