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CTRI Number  CTRI/2024/05/066945 [Registered on: 07/05/2024] Trial Registered Prospectively
Last Modified On: 16/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Other 
Public Title of Study   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. 
Scientific Title of Study   A Randomized, Placebo-Controlled Prospective Study to Evaluate the Efficacy and Safety of Dose for CholesterolTM (Dietary supplement) and to assess the effect of Dose for CholesterolTM on Cholesterol levels in healthy adults. 
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 - Clinical Operation 
Affiliation  Concept Clinical Services  
Address  9th Floor, 903, Rajhnas complex, Beside Nirmal Hospital Pvt Ltd, Ring Road

Surat
GUJARAT
395002
India 
Phone  9979530073  
Fax    
Email  Nimish@conceptclinicals.com  
 
Details of Contact Person
Scientific Query
 
Name  Mr Nimish Dudhatra 
Designation  Head - Clinical Operation 
Affiliation  Concept Clinical Services  
Address  9th Floor, 903, Rajhnas complex, Beside Nirmal Hospital Pvt Ltd, Ring Road

Surat
GUJARAT
395002
India 
Phone  9979530073  
Fax    
Email  Nimish@conceptclinicals.com  
 
Details of Contact Person
Public Query
 
Name  Mr Nimish Dudhatra 
Designation  Head - Clinical Operation 
Affiliation  Concept Clinical Services  
Address  9th Floor, 903, Rajhnas complex, Beside Nirmal Hospital Pvt Ltd, Ring Road

Surat
GUJARAT
395002
India 
Phone  9979530073  
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 [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 Niranjankumar Prafulchandra Panchal  Unity Trauma Centre and ICU (Unity Hospital)  Clinical Research Department, Basement, Nr. D.R World, Opp Raghuvir Business Empire, Aai Mata Road, Parvat Patiya
Surat
GUJARAT 
9724345654

drniranjanppanchal@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  Dose for CholesterolTM (Dietary supplement) in improving cholesterol levels in the healthy adults. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  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 bottle (60ml) after meals Duration: 90 Days 
Comparator Agent  Placebo  Subjects will be counselled to use: Dose for CholesterolTM (Dietary Supplement)/ Placebo Dose: 60 ml twice a day Route: Oral Regimen: 1 bottle (60ml) after meals Duration: 90 Days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 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. 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) 
 
ExclusionCriteria 
Details  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. 
 
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 the impact of Dose for CholesterolTM (Dietary supplement) in improving cholesterol levels in the healthy adults.  Efficacy Endpoints- Time frame- Baseline to Day 91
Safety Endpoints-Time frame - Baseline to Day 91 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the safety of Dose for CholesterolTM (Dietary supplement) in the adult healthy adults  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. 
 
Target Sample Size   Total Sample Size="86"
Sample Size from India="86" 
Final Enrollment numbers achieved (Total)= "86"
Final Enrollment numbers achieved (India)="86" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   20/05/2024 
Date of Study Completion (India) 16/09/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
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)?  

Response - NO
Brief Summary   Study Title : A Randomized, Placebo-Controlled Prospective Study to Evaluate the Efficacy and Safety of Dose for CholesterolTM (Dietary supplement) and to assess the effect of Dose for CholesterolTM on Cholesterol levels in healthy adults.

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:

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.
 
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