CTRI/2023/12/060512尚未招募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 - NI
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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/d
排除标准
- •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
- •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
- •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
- •17. Any other condition which the Principal Investigator thinks may jeopardize the study.
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