CTRI/2022/09/045585已完成4 期
A prospective, multicenter, open label clinical trial to evaluate efficacy and safety of Vestige Spirulina capsules in overall immunity of Healthy subjects.
Vestige Marketing Pvt Ltd0 个研究点目标入组 50 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
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. Subject is willing and able to give written informed consent.
- •2. Aged 18-65 years of age
- •3. Healthy Men and non-pregnant women
- •4. Subject is willing, able, and likely to comply with all study procedures and
- •restrictions.
排除标准
- •1. Current or 12 months prior to screening severe cardiovascular diseases, including: NYHA Class III or IV chronic heart failure, clinically significant ventricular arrhythmias (ventricular tachycardia, ventricular fibrillation), unstable angina, myocardial infarction, heart and coronary vessel surgery, significant valvular heart disease, uncontrolled arterial hypertension with systolic blood pressure >180 mm Hg and diastolic blood pressure >110 mm Hg, pulmonary embolism or deep vein thrombosis.
- •2. Type 1 diabetes mellitus and uncontrolled type 2 diabetes mellitus (HbA1c > 10.5 %, fasting plasma glucose >270 mg/dl at screening or episodes of severe hypoglycemia 1 month prior to screening);
- •3. Severe diseases of the central nervous system, including seizures in history or conditions that may lead to their development; stroke or transient ischemic attack within 12 months prior to screening; head injuries or loss of consciousness within 12 months prior to screening; a brain tumor.
- •4. Significant uncontrolled concomitant disease, such as neurological, renal, hepatic, endocrine and gastrointestinal which according to the Investigator, could prevent the patient from participating in the study.
- •5. Participation in other clinical studies or administration of investigational products within 4 weeks prior to screening.
- •6. HIV, active viral (hepatitis B and C) or a cirrhotic liver disease in medical history.
- •7. Malignancies within the last 5 years (except for basal cell carcinoma of the skin and cervical cancer in situ that had undergone surgical removal or treatment).
- •8. Drug or alcohol abuse at the time of screening or in the past which, in the opinion of the Investigator, makes the patient unsuitable for participation in the study.
- •9. Pregnant or lactating women or women planning a pregnancy during the clinical study.
- •10. Inability to read or write, unwillingness to understand and follow procedures of study protocol, as well as any other concomitant medical or serious mental conditions that make the patient unfit to participate in the study, limit the legality of obtaining informed consent or can affect patient’s ability to participate in the study.
研究者
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