CTRI/2023/12/060512已完成3 期
A randomized double blinded placebo controlled clinical study to evaluate the efficacy and safety of S allylcysteine as an adjuvant treatment in patients with Grade 1 Grade 2 hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 3
- 主要终点
- 1. Mean change in Systolic Blood Pressure & Diastolic Blood Pressure
研究概览
简要总结
This study involves 70 subjects randomized in two arms and will receive 90 days of treatment and telephonic follow up after seven days following the last visit. Participant will be randomized to receive 200 mg (aged garlic extract containing 1- 1.5 mg of SAC) [arm 1] or 200 mg of placebo (microcrystalline cellulose) [arm 2]. Mean change in pulse pressure and blood pressure will be measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •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/dL.
排除标准
- •Patients with more than one antihypertensive drugs.
- •Participants with secondary hypertension.
- •Participants with hypertensive crisis.
- •Patients with uncontrolled hypertension with medication.
- •Participants with HbA1c > 6.5%.
- •Intake of over the counter or prescribed Allopathic/Ayurvedic/ Homeopathic/Naturopathic medications.
- •History of chronic smoking (more than 2 cigarettes a day)
- •Alcoholics (Inability to control drinking due to both physical & emotional dependence on alcohol characterized by uncontrolled drinking & preoccupation with alcohol).
- •Patients with evidence of malignancy.
- •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].
- •History of severe psychiatric disorders like schizophrenia or bipolar disorder.
- •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.
- •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).
- •History of hypersensitivity to any of the herbal extracts or dietary supplement.
- •Pregnant/lactating women and those not willing to follow a reliable and effective contraceptive measure during the study.
- •Those who have participated in any other clinical trial within three months from the screening.
- •Any other condition which the Principal Investigator thinks may jeopardize the study.
结局指标
主要结局
1. Mean change in Systolic Blood Pressure & Diastolic Blood Pressure
时间窗: 1. Screening to Day 90 | 2. Screening to Day 90
2. Mean change in Pulse pressure
时间窗: 1. Screening to Day 90 | 2. Screening to Day 90
次要结局
- Mean change in Lipid profile
- Mean change in participants quality of life through WHO-BREF questionnaire(Safety is determined by the incidence of AE/SAE in both groups)
研究者
Dr Sanjana Kumari V T
Sri Laxmi Hospital
研究点 (3)
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