Health Condition 1: I10- Essential (primary) hypertension
Conditions
Interventions
Intervention1: Aged garlic extract: 200 mg capsule [Aged garlic extract containing 1-1.5 mg S allyl cysteine] once a day after dinner for 90 days
Control Intervention1: Microcrystalline cellulose: 200
Sponsors
Sami Sabinsa Group Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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 3) LDL cholesterol > 120 to 160 mg/dL 4) Serum Total Cholesterol > 200 to 250 mg/dL
Exclusion criteria
Exclusion criteria: 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Mean change in Systolic Blood Pressure & Diastolic Blood Pressure 2. Mean change in Pulse pressureTimepoint: 1. Screening to Day 90 2. Screening to Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in Lipid profile Timepoint: Screening to Day-90 ;Mean change in participants quality of life through WHO-BREF questionnaire Safety is determined by the incidence of AE/SAE in both groupsTimepoint: Randomization Day to Day-90 | — |
Countries
India
Contacts
Public ContactMr Satish G
Sami Sabinsa Group Limited
Outcome results
None listed