CTRI/2022/03/040717尚未招募3 期
A Clinical Study of Ayurvedic formulation on Hyperlipidemia
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
- •Having all or at least two of the lipids above the normal range as under :
- •Ã¢â?¬Â¢Serum cholesterol level- ââ?°Â¥200 mg/ dl (ââ?°Â¥5.2 mmol/l)
- •Ã¢â?¬Â¢Serum Triglycerides level-ââ?°Â¥150 mg/ dl (ââ?°Â¥1.7 mmol/l)
- •Ã¢â?¬Â¢HDL-C level-Ã?â??40 mg/dl (Ã?â??1.04 mmol/l)
- •Ã¢â?¬Â¢LDL- level - ââ?°Â¥130 mg/dl (ââ?°Â¥3.4 mmol/l)
- •Participant willing and able to participate in the study.
排除标准
- •Ã¢â?¬Â¢Patients with poorly controlled Hypertension ( >160/100mmHg)
- •Ã¢â?¬Â¢Pregnant/ lactating females.
- •Ã¢â?¬Â¢Patients on prolonged ( > 6 weeks) medication with corticosteoids, antidepressants, anticholinergics, immune suppressants, estrogen replacement therapy etc. or any other drugs that may have an influence on the outcome of the study.
- •Ã¢â?¬Â¢Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Tuberculosis, Psycho-Neuro-Endocrinal disorders, etc.)
- •Ã¢â?¬Â¢Patients who have a past history of Atrial Fibrillation, or Severe Arrhythmia
- •Ã¢â?¬Â¢Symptomatic patients with clinical evidence of Heart failure.
- •Ã¢â?¬Â¢Patients with uncontrolled Diabetes Mellitus (Blood Sugar Fasting > 200mg/dl)
- •Ã¢â?¬Â¢Patients with concurrent serious hepatic disorder (defined as aspartate amino transferase (AST) and / or alanine amino transferase (ALT), total bilirubin or alkaline phosphatase (ALP) > 3 times upper normal limit) or renal disorders (defined as S.creatinine >1.2mg/dL)
- •Ã¢â?¬Â¢Patients with uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or Other concurrent severe disease
- •Ã¢â?¬Â¢Patients with evidence of malignancy
- •Ã¢â?¬Â¢History of Hypersensitivity to any of the trial drug or its ingredients
- •Ã¢â?¬Â¢History of Hypothyroidism
- •Ã¢â?¬Â¢Patients who have completed participation in any other clinical trial during the past six (06) months
- •Ã¢â?¬Â¢Patients who received any cholesterol lowering medication within last 08 weeks before screening.
- •Ã¢â?¬Â¢Any other condition which the Investigator thinks may jeopardize the study.
研究者
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