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.
Scientific Title of Study
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.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Mr Nimish Dudhatra
Designation
Head
Affiliation
Concept Clinical Services
Address
Department: Not Applicable
Division: Not Applicable
Room no :903
9th Floor, Rajhnas complex, Beside Nirmal Hospital, Ring Road.
Surat GUJARAT 395002 India
Phone
919979530073
Fax
Email
nimish@conceptclinicals.com
Details of Contact Person Scientific Query
Name
Mr Nimish Dudhatra
Designation
Head
Affiliation
Concept Clinical Services
Address
Department: Not Applicable
Division: Not Applicable
Room no :903
9th Floor, Rajhnas complex, Beside Nirmal Hospital, Ring Road.
Surat GUJARAT 395002 India
Phone
919979530073
Fax
Email
nimish@conceptclinicals.com
Details of Contact Person Public Query
Name
Mr Nimish Dudhatra
Designation
Head
Affiliation
Concept Clinical Services
Address
Department: Not Applicable
Division: Not Applicable
Room no :903
9th Floor, Rajhnas complex, Beside Nirmal Hospital, Ring Road.
Surat GUJARAT 395002 India
Phone
919979530073
Fax
Email
nimish@conceptclinicals.com
Source of Monetary or Material Support
EETHO BRANDS INC 4210, Del Rey Ave #409 Marina Del Rey, CA 90920 USA
Primary Sponsor
Name
EETHO BRANDS INC
Address
4210, Del Rey Ave #409 Marina Del Rey,CA 90920 USA
Type of Sponsor
Other [Other [Nutraceutical]]
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Saumin Prakashbhai Shah
Unity Trauma Centre and ICU, Unity Hospital
Departmentment: OPD
Division: Not Applicable
Room Number: Not Applicable
Nr. D.R World, Opp. Raghuvir Business Empire, Aai Mata Road, Parvat Patiya. Surat GUJARAT
9408042224
dr.sauminpshah@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
UNITY HOSPITAL ETHICS COMMITTEE
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
Impact on Liver Function Test parameters and other health markers associated with Liver
Intervention / Comparator Agent
Type
Name
Details
Intervention
Dose for your Liver (Dietary
supplement)
Shake well and take one bottle (60mL) of oral suspension of investigational product (IP) either Test or Placebo once a day following meals (i.e. preferably in the morning)
Comparator Agent
Placebo
Shake well and take one bottle (60mL) of oral suspension of investigational product (IP) either Test or Placebo once a day following meals (i.e. preferably in the morning)
Inclusion Criteria
Age From
18.00 Year(s)
Age To
60.00 Year(s)
Gender
Both
Details
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.
ExclusionCriteria
Details
Participants will be excluded from the study if they fulfil any of the following criteria:
1. High grade fever defined as body temperature greater than equal to 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, Parkinson’s disease,Alzheimer’s 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.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Pre-numbered or coded identical Containers
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
To evaluate effect of Dose for your Liver (Dietary Supplement) in comparison with placebo in healthy subjects.
90 plus or minus 5 days
Secondary Outcome
Outcome
TimePoints
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.
90 plus or minus 5 days
To observe changes in the Quality of life from baseline to End of treatment.
90 plus or minus 5 days
Target Sample Size
Total Sample Size="100" Sample Size from India="100" Final Enrollment numbers achieved (Total)= "108" Final Enrollment numbers achieved (India)="108"
Phase of Trial
Phase 3
Date of First Enrollment (India)
29/01/2025
Date of Study Completion (India)
16/06/2025
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Date Missing
Estimated Duration of Trial
Years="0" Months="10" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Completed
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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.