CTRI/2024/05/067632尚未招募4 期
Post marketing surveillance to determine the clinical efficacy and safety of Ayukalash on selected Cardiovascular Disorders (dyslipidemia and hypertension). - NI
Med Pharma CRO0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1.Patients suffering from Dyslipidemia and/or having Hypertension.
- •2.With/without treatment with lipid-lowering medications, lifestyle modifications, including diet or exercise and no contraindication to receiving Ayukalash.
- •3.Patients willing to give written informed consent and adhere to visit schedules and meet study requirements.
- •4.Patients willing to perform all study related procedures including the use of study medicine, allow the physical and other study related procedures (invasive & non-invasive) and willing to document symptoms and medication.
- •5.Agree to following instruction of do’s and don’ts in regular daily lifestyle.
- •6.Study participants are fit and no need any hospital administration.
排除标准
- •1. Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences and inability to carry out visits for the study.
- •2. Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with participation in the study, and/or put the patient at significant risk (according to investigator’s [or delegate’s] judgment) if he/she participates in the study.
- •3. An underlying known disease, or surgical, physical, or medical condition that, in the opinion of the investigator [or delegate) might interfere with interpretation of the clinical study results.
- •4. Serious comorbid disease in which the life expectancy of the patient is shorter than the duration of the trial (e.g., acute systemic infection, cancer, or other serious illnesses).
- •5. Females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least two methods of contraception (e.g., oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, intrauterine device) for the entire duration of the study.
研究者
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