| CTRI Number |
CTRI/2021/08/035359 [Registered on: 03/08/2021] Trial Registered Prospectively |
| Last Modified On: |
04/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical study of Dose for your Liver (Dietary Supplement) in patients with Non-alcoholic Fatty Liver Disease |
|
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) in patients with Non-alcoholic Fatty Liver Disease (NAFLD) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CSI2102, Version 1.0 dated 22-Feb-2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jignesh Patel |
| Designation |
Principal Investigator |
| Affiliation |
Sanjivani Super Speciality Hospital Pvt. Ltd. |
| Address |
Sanjivani Super Speciality Hospital Pvt. Ltd., Department of Gastroenterology, Ground Floor,1, New Uday Park Society, Near Sunrise Park, Vastrapur.
Ahmadabad
GUJARAT
380015
India |
| Phone |
9727735536 |
| Fax |
|
| Email |
drjigs2712@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jignesh H Patel |
| Designation |
AGM, Medical and Regulatory Affairs |
| Affiliation |
COD Research Pvt Ltd |
| Address |
COD Research Pvt Ltd 301, I-Square, Near Shukan Mall, Science City Road, Sola.
Ahmadabad
GUJARAT
380060
India |
| Phone |
8422974431 |
| Fax |
|
| Email |
jignesh.p@cod-research.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Nimesh Parekh |
| Designation |
Chief Operating Officer |
| Affiliation |
COD Research Pvt Ltd |
| Address |
COD Research Pvt Ltd 301, I-Square, Near Shukan Mall, Science City Road, Sola.
Ahmadabad
GUJARAT
380060
India |
| Phone |
9904468245 |
| Fax |
|
| Email |
nimesh.p@cod-research.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Eetho Brands Inc |
| Address |
4210 Del Rey Ave, 409
Marina Del Rey, CA 90292 |
| Type of Sponsor |
Other [Beverage Companies-USA] |
|
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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 Jignesh Patel |
Sanjivani Super Speciality Hospital Pvt. Ltd. |
Department of Gastroenterology, Ground Floor,1, New Uday Park Society, Near Sunrise Park, Vastrapur.
Ahmadabad
GUJARAT |
9727735536
drjigs2712@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sanjivani Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K760||Fatty (change of) liver, not elsewhere classified, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Placebo | Content: Matching placebo of test product
Dose: 60 mL
Frequency: Twice daily with meal Route of administration: Oral Duration of therapy: 60 Days | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Dose for your Liver (Dietary Supplement), Reference: NA, Route: Oral, Dosage Form: Swaras/ Juice, Dose: 60(ml), Frequency: bd, Bhaishajya Kal: Madhyabhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: NA |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Willing and able to provide written informed consent prior to any study-related activities being performed.
2. Able and willing to comply with the protocol, including availability for all scheduled study visits.
3. Male and Female patients aged between 18 years to 70, both inclusive.
4. Patients diagnosed with fatty liver (grades 1-3) based on liver USG.
5. Women of child bearing potential, (defined as women physiologically capable of becoming pregnant, unless they are using effective method of contraception during dosing of the investigational product) practicing any two acceptable methods of contraception.
6. Female patients with negative urine pregnancy test (only for female who has not completed 1 year after menopause & have not gone through hysterectomy or bilateral tubal ligation).
|
|
| ExclusionCriteria |
| Details |
1. Hypersensitivity to contents of Dose for your Liver or related class of drugs or to any of the excipients of the formulation.
2. Fatty liver secondary to alcohol consumption.
3. History of regular alcohol consumption exceeding 14 drinks per week for female subjects or 21 drinks per week for male subjects (1 drink is equal to 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.
4. Addicted Alcoholics and- or drug abusers.
5. History or presence of coronary, renal, pulmonary and thyroid disease.
6. AST and ALT more than 5 times ULN; Serum bilirubin more than ULN and Platelet Count less than 95,000 per microleter.
7. Patients using hypolipidemic medications as well as any drug known to affect hepatic function 4 weeks prior to randomization.
8. Difficulty in swallowing and retaining oral formulation.
9. Known HBsAg positive, Anti HCV and HIV positive, hereditary defects of iron, copper and alpha-1 antitrypsin deficient patients.
10. Hypothyroidism, obstructive sleep apnoea, total parenteral nutrition, short bowel syndrome, pancreatoduodenal resection which are secondary causes of NAFLD.
11. Patient has condition or is in a situation which, in the investigator’s opinion, may have put the patient at a significant risk, may have confounded study results, or may have interfered significantly with the patient’s participation in the study.
12. Participation in any other clinical study within 30 days before the first dose of Investigational Product.
13. Pregnant or Lactating female patient.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage of patients showing improvement in fatty liver grading from baseline based on liver USG |
from baseline to day 60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in fatty liver grading based on liver USG
AST to Platelet Ratio Index (APRI)
Change in CAP score based on Fibroscan
Change in lipid profile and liver enzymes ALT and AST
|
from baseline to day 60 |
| Safety Outcome: Number and types of adverse (AEs) and serious adverse events (SAEs) |
from baseline to day 67 |
|
Target Sample Size
Modification(s)
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
23/08/2021 |
| Date of Study Completion (India) |
25/11/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The current study is designed as a prospective, randomized, double-blind, placebo-controlled, parallel group study in male and non-pregnant female patients with NAFLD. This study involves a screening phase, randomization and treatment phase, and follow-up phase as mentioned below: Screening phase (Visit 1): -14 days to -1 day Day of randomization (Visit 2): Day 0 Initiation of treatment: Day 1 Interim follow up visit (Visit 3): Day 31 ±2 days End of treatment (Visit 4): Day 61 ±2 days End of study (telephonic safety call): Day 67 ±2 days Treatment phase: 60 Days Patients considered eligible will be randomized and enter into treatment phase. A total of 30 patients will be enrolled in the study in a randomization ratio of 1:1 to receive test and its matching placebo products, respectively. |