None listed
Conditions
Interventions
Intervention1: Dose for CholesterolTM (Dietary supplement): Subjects will be counselled to use:
Dose for CholesterolTM (Dietary Supplement)/ Placebo Dose: 60 ml twice a day Route: Oral
Regimen: 1 bott
Sponsors
EETHO BRANDS INC
Eligibility
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the impact of Dose for CholesterolTM (Dietary supplement) in improving cholesterol levels in the healthy adults.Timepoint: Efficacy Endpoints- Time frame- Baseline to Day 91 Safety Endpoints-Time frame - Baseline to Day 91 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety of Dose for CholesterolTM (Dietary supplement) in the adult healthy adultsTimepoint: a. Mean change in vital sign parameters from baseline to end of the study. b. Change in laboratory safety parameters (hematological parameters, liver function, biochemistry & kidney function) from baseline to the end of the study. c. Occurrence and severity of adverse events during the study period. | — |
Countries
India
Contacts
Public ContactMr Nimish Dudhatra
Concept Clinical Services
Outcome results
None listed