CTRI/2024/05/066945进行中（未招募）3 期
A Randomized, Placebo-Controlled Prospective Study to Evaluate the Efficacy and Safety of Dose for CholesterolTM (Dietary supplement) and to assess the effect of Dose for CholesterolTM on Cholesterol levels in healthy adults. - Nil
EETHO BRANDS INC0 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
- 3 期
- 状态
- 进行中（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
- Interventional
入排标准
入选标准
- •Participants are eligible to participate in the study only if they qualify all the inclusion criteria mentioned below.
- •1. Able to provide written informed consent.
- •2. Able and willing to comply with the protocol, including availability for all scheduled study visits.
- •3. Healthy male or female aged between 18 and 65 years (both inclusive), as of the screening date.
- •4. Subjects with lipid levels confirmed by laboratory testing, including:
- •Triglycerides less than 150 mg/dL,
- •Total cholesterol less than 200 mg/dL
- •LDL cholesterol less than 100 mg/dL, and
- •HDL more than 40 mg/dL
- •5. Participants must not have taken any medication (including herbal products) for managing lipid levels in the last 4 weeks.
- •6. Participants with a BMI within the range of 20 to 30 kg/m².
- •7. Females of Child-Bearing Potential /Post Menopausal Women with less than 1 year from the last cycle; complying to use the accepted methods of contraception. (Barrier Methods, Female/Male Sterilization - at least 24 weeks prior to date of informed consent, IUDs, Oral/ Parenteral Contraceptive)
排除标准
- •Participants will be excluded from the study if they fulfil any of the following criteria:
- •1. Females who are pregnant or planning pregnancy, lactating, or using non accepted methods of contraception. (Periodic Abstinence)
- •2. Participants with a history of heart conditions such as heart failure, coronary artery disease, or cardiomyopathies.
- •3. Participants with a history of immunocompromised states, whether with or without organ transplant.
- •4. Individuals with known or suspected hypersensitivity or intolerance to herbal products or Dose for CholesterolTM.
- •5. Individuals with more than two specified risk factors (cigarette smoking, hypertension, family history of premature Congenital Heart Defects).
- •6. Subjects with hepatic or renal impairment, severe systemic illness, metabolic disorders, gastrointestinal diseases, uncontrolled cardiovascular disease, or advanced atherosclerosis.
- •7. Subjects with triglyceride levels exceeding 200 mg/dL, diabetes (FBS more than 150 mg/dL), and those using insulin or unstable hypoglycemic medications.
- •8. Participants using medications, nutritional products, and dietary supplements that may interfere with the study results, as determined by the investigator s opinion.
- •9. Individuals with a history of allergy or sensitivity to any ingredient in the test product, as well as a history of alcohol or other drug abuse within the last year.
- •10. Those who have participated in another clinical study within the past 30 days.
- •11. Any condition that, in the investigator s judgment, could impede a participant s successful and safe completion of the study or potentially confound study outcomes.
- •12. Individuals who are not ready to comply with the study procedures.
研究者
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