A prospective, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of Dose for your Liver (Dietary Supplement) on Liver Health in healthy volunteers.

Study Title: A prospective, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of Dose for your Liver (Dietary Supplement) on Liver Health in healthy volunteers.

Phase of study: Phase III

Study design: Prospective, Randomized, placebo controlled, double blind study.

Trial location: India (Single centre study)

Investigational product (IP): “ Dose for your Liver" (Dietary Supplement) of Eetho Brands, Inc.

Study population: Literate & healthy adult population comprising of male and non pregnant female individuals of age 18 to 60 years (both inclusive) Number of subjects 120 adult volunteers 50 in Test group 50 in Placebo group) will be enrolled and randomized to receive either test or placebo product.

Primary Objective:

To evaluate effect of Dose for your Liver (Dietary Supplement) in comparison with placebo in healthy subjects.

Secondary Objective(s):

1. To evaluate safety of “Dose for your Liver” (Dietary Supplement) in comparison with placebo.

2.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.

3. To observe changes in the Quality of life from baseline to End of treatment.

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. Literate Male and female individuals aged between 18 and 60 years (complete),as of the screening date, both inclusive.

4. Female subjects with negative urine pregnancy test.(Only for females 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:

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 hypersensitivity 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. History of regular alcohol consumption exceeding 14 drinks/week for female subjects or 21 drinks/week for male subjects (1 drink = 5 ounce [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within the previous 6 months from screening.

7. Are addicted alcoholics and/or drug abusers.

8. Has history or presence of coronary, renal, pulmonary and thyroid disease.

9. Has used hypolipidemic medications as well as any drug known to affect hepatic function 4 weeks prior to randomization

10. Participants with history of heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies

11. Participants with history of immunocompromised state immune system with/without organ transplant

12. Has difficulty in swallowing and retaining oral formulation.

13. Is known HBsAg positive, HCV and/or HIV positive. Has hereditary defects of iron, copper and alpha- 1 antitrypsin deficient subjects.

14. Has hypothyroidism, obstructive sleep apnea, total parenteral nutrition, short bowel syndrome, pancreatoduodenal resection that are known to have indirect impact on Liver functions.

15. 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

16. 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.

17. 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.

18. Those who have severe mental illnesses, such as dementia, Parkinsons disease, Alzheimers Disease, depression or anxiety disorders, or those who are currently taking psychoneurological drugs, such as antidepressants.

19. 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.

20. Individuals having a history of smoking or currently smoking or using any form of smokeless tobacco.

21. Females who are pregnant/planning to be pregnant/lactating.

CONCLUSION:

In this study, the efficacy and safety of the Test product, Dose for your Liver, were comprehensively evaluated through a range of efficacy and safety endpoints over a period 90 days, starting from baseline to the end of treatment (EOT). The primary focus of the efficacy endpoints was on assessing changes in liver profile parameters, including Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline phosphatase (ALP), Gamma-Glutamyl Transferase (GGT), and Bilirubin.

The results revealed significant improvements in several liver profile components, including Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline phosphatase (ALP), Gamma-Glutamyl Transferase (GGT), and Bilirubin levels, in the Test group, with highly significant differences compared to the placebo group. Additionally, the improvements in APRI levels, where the Test group demonstrated a significantly greater improvement than the placebo group. These differences were substantiated by p-values of less than 0.0001, indicating highly statistical significance. Moreover, these findings suggest a potential

beneficial effect of the Test product. Overall, these results suggest that the Test product plays a positive role in improving liver health.

Safety endpoints were thoroughly assessed and included lipid profile, complete blood count (CBC) parameters, kidney function tests (KFTs), and quality of life (QoL) While all parameters remained within the normal healthy range, a trend of improvement was observed in several safety endpoints within the Test group. Liver function markers, including ALT, AST, and ALP, showed favourable changes, suggesting a potential hepatoprotective effect of the Test product. Furthermore, kidney function markers, including serum creatinine and blood urea nitrogen (BUN), also demonstrated positive trends, reinforcing the safety of the Test product with respect to renal function.

In summary, the study demonstrated that Dose for your liver is both efficacious and safe. The Test product led to significant improvements in liver profile with marked efficacy compared to the placebo group. In terms of safety, the product exhibited a positive trend across various parameters, with no clinically significant adverse effects, further supporting its suitability for long-term use. These findings suggest that Dose for your liver may provide meaningful benefits in managing liver health and overall metabolic health while maintaining an excellent safety profile.