To evaluate the benefits and side effects of garlic extract in the patients with mild hypertension who are under standard care of treatment.
- Conditions
- Health Condition 1: I10- Essential (primary) hypertension
- Registration Number
- CTRI/2023/12/060512
- Lead Sponsor
- Sami Sabinsa Group Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1 Male and Female participants whose age = 18 and = 60 years
2 Participants must provide a written and signed informed consent and comply with requirements of the study
3 Must be able to swallow oral medications for 90 days daily and comply with the study requirements as per the protocol
4 Known case of Grade 1 / Grade 2 hypertension (Systolic BP 120-159mmHg & Diastolic BP 80 – 99mmHg) with the use of antihypertensive medication
5 Patients should be on monotherapy & with a mild dose of antihypertensive drug
6 Subjects who meet any of the two following criteria to be included in the study
1) Triglyceride > 150 to 200mg/dl
2) HDL cholesterol < 50 mg/dL (or 1 29 mmol/L) in women or < 40 mg/dL (or 1 04 mmol/L) in men
3) LDL cholesterol > 120 to 160 mg/dL
4) Serum Total Cholesterol > 200 to 250 mg/d
1. Patients with more than one antihypertensive drugs.
2. Participants with secondary hypertension.
3. Participants with hypertensive crisis.
4. Patients with uncontrolled hypertension with medication.
5. Participants with HbA1c > 6.5%.
6. Intake of over the counter or prescribed Allopathic/Ayurvedic/
Homeopathic/Naturopathic medications.
7. History of chronic smoking (more than 2 cigarettes a day)
8. Alcoholics (Inability to control drinking due to both physical & emotional dependence
on alcohol characterized by uncontrolled drinking & preoccupation with alcohol).
9. Patients with evidence of malignancy.
10. Patients having history of coagulopathies, cardiovascular diseases, congestive heart
failure, pancreatitis, lactic acidosis, hepatomegaly with steatosis, motor weakness,
peripheral sensory neuropathy, psychiatric disorder, Severe Pulmonary Dysfunction
(uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease
[COPD].
11. History of severe psychiatric disorders like schizophrenia or bipolar disorder.
12. Patients on prolonged ( > 4 weeks) medication with corticosteroids, antidepressants,
anticholinergics, etc. or any other drugs that may have an influence on the outcome of
the study.
13. Patients with concurrent serious hepatic disorder (defined as Aspartate Amino
Transferase (AST) and/or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline
Phosphatase (ALP) >2 times upper normal limit) or Renal Disorders (defined as S.
Creatinine >1.2mg/dL for females or >1.4 mg/dL for males and EGFR <60).
14. History of hypersensitivity to any of the herbal extracts or dietary supplement.
15. Pregnant/lactating women and those not willing to follow a reliable and effective
contraceptive measure during the study.
16. Those who have participated in any other clinical trial within three months from the
screening.
17. Any other condition which the Principal Investigator thinks may jeopardize the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Mean change in Systolic Blood Pressure & Diastolic Blood Pressure <br/ ><br>2. Mean change in Pulse pressureTimepoint: 1. Screening to Day 90 <br/ ><br>2. Screening to Day 90
- Secondary Outcome Measures
Name Time Method Mean change in Lipid profile <br/ ><br>Timepoint: Screening to Day-90 <br/ ><br>;Mean change in participants quality of life through WHO-BREF questionnaire <br/ ><br>Safety is determined by the incidence of AE/SAE in both groupsTimepoint: Randomization Day to Day-90