| 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
|
|
|
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
|
|
|
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. |