Evaluate the Efficacy and Safety of Dose for cholesterolTM (Dietary supplement) and assess the effect of Dose for CholesterolTM on Cholesterol levels in healthy adults.
- Registration Number
- CTRI/2024/05/066945
- Lead Sponsor
- EETHO BRANDS INC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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)
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method