None listed
Conditions
Interventions
Intervention1: “Dose for your Liver ? (Dietary supplement): Shake well and take one bottle (60mL) of oral suspension of investigational
product (IP) either test or placebo twice a day following meals
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 v isits. 3. Literate Male and female individuals aged between 18 and 6 0 years (complete), as of the screening date, both 4. Female subject s with negative urine pregnancy test Only for female s who had not completed 1 year after menopause & had not gone through hysterectomy or bilateral tubal ligation) 5. Participants with liver function test markers within upper normal limits.
Exclusion criteria
Exclusion criteria: Participants will be excluded from the study if they fulfil any of the following criteria: 1. High grade fever defined as body temperature = 40°C. 2. Participants with known or suspected hypersensitivity or intolerance to herbal products like turmeric, dandelion, ginger, or organic milk thistle extract 3. Has hyper sensitivity to Dose for your Liver (Dietary Supplement/ Investigational Product) or related class of drugs or to any of the excipients of the formulation. 4. Participants with liver function test markers above normal limits 5. Has presence of any liver related disease or abnormalities 6. Are addicted alcoholics and/or drug abusers. 7. Has history or presence of coronary, renal, pulmonary and thyroid disease. 8. Has used hypolipidemic medications as well as any drug known to affect hepatic function 4 weeks prior to randomization 9. Participants with history of heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies 10. Participants with history of immunocompromised state immune system with/without organ transplant 11. Has difficulty in swallowing and retaining oral formulation. 12. Is known HBsAg positive, HCV and/or HIV positive. Has hereditary defects of iron, copper and alpha 1 antitrypsin deficient subjects. 13. Has hypothyroidism, obstructive sleep apnea, total parenteral nutrition, short bowel syndrome, pancreatoduodenal resection that are known to have indirect impact on Liver functions 14. Had condition or was in a situation that, in the investigator’s opinion, had put the subject at a significant risk, had confounded study results, or had interfered significantly with the subject’s participation in the study 15. Those who are not willing to abstain from other home-based remedies that include decoctions or any other form of dietary supplements during the entirety of study participation period. 16. Those who have taken or should be taking or are taking antibiotics, antivirals, steroids, or other medications within one week of the start of the study. 17. Those who have severe mental illnesses, such as dementia, Parkinson’s disease, Alzheimer’s Disease, depression or anxiety disorders, or those who are currently taking psychoneurological drugs, such as antidepressants. 18. Those who have participated in other clinical trials within 30 days, prior to the screening visit or plan to participate in other clinical trials during the trial period. 19. Individuals having a history of smoking or currently smoking or using any form of smokeless tobacco. 20. Females who are pregnant/planning to be pregnant/lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate effect of Dose for your Liver (Dietary Supplement) in comparison with placebo in healthy subjects.Timepoint: 181 ± 2 days | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess an overall effect of the investigational product in comparison to placebo on various biochemical parameters (Liver Function Test, Kidney Function Test, Lipid Profile Test & significant others directly or indirectly associated with liver functions at the end of study.Timepoint: 181 ± 2 days;To evaluate safety of Dose for your Liver (Dietary Supplement) in comparison with placeboTimepoint: 181 ± 2 days | — |
Countries
India
Contacts
Public ContactMr Nimish Dudhatra
Concept Clinical Services
Outcome results
None listed