| CTRI Number |
CTRI/2021/11/037789 [Registered on: 03/11/2021] Trial Registered Prospectively |
| Last Modified On: |
19/05/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Clinical Study on Two Strains of Nichi Glucan AFO-202 and N-163 in NAFLD |
|
Scientific Title of Study
|
An Open Label, Prospective, Randomised, Comparative, Two Arm Clinical Study to Evaluate the Safety, Efficacy and Tolerability of Two Strains of Nichi Glucan AFO-202 and N-163 as an Add on Therapy in Comparison with Conventional Therapeutic Regimen in Adult Subjects with NAFLD. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NBS/DDP/AHC/F19S/NASH Version 01 16-Aug-21 |
Protocol Number |
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|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Preethy SP |
| Designation |
Trial Coordinator |
| Affiliation |
Medi Nippon Health Care Private Limited |
| Address |
No.6, Zakariah Colony III St., Choolaimedu
Chennai
TAMIL NADU
600094
India |
| Phone |
04424733255 |
| Fax |
|
| Email |
drspp@nichimail.jp |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preethy SP |
| Designation |
Trial Coordinator |
| Affiliation |
Medi Nippon Health Care Private Limited |
| Address |
No.6, Zakariah Colony III St., Choolaimedu
TAMIL NADU
600094
India |
| Phone |
04424733255 |
| Fax |
|
| Email |
drspp@nichimail.jp |
|
Details of Contact Person
Public Query
|
| Name |
Dr Preethy SP |
| Designation |
Trial Coordinator |
| Affiliation |
Medi Nippon Health Care Private Limited |
| Address |
No.6, Zakariah Colony III St., Choolaimedu
TAMIL NADU
600094
India |
| Phone |
04424733255 |
| Fax |
|
| Email |
drspp@nichimail.jp |
|
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Source of Monetary or Material Support
|
| M/s GN Corporation Co., Ltd.
3-8 Wakamatsu, Kofu,
Yamanashi Prefecture 400-0866, JAPAN. |
|
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Primary Sponsor
|
| Name |
NichiIn Bio Sciences Pvt Ltd |
| Address |
B6, 13, Zakariah Colony III St, Choolaimedu
Chennai 600 094, Tamil Nadu, INDIA
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| MediNippon Healthcare Pvt Ltd |
No.6, Zakariah Colony III St., Choolaimedu Chennai 600 094,
Tamil Nadu, INDIA
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr CJ Vetrivel |
Be Well Hospitals Private Limited |
Room No 1,
Department of Gastroenterology
No2, (Old No 5), Vijayaraghava Road,
1st Street, T. Nagar
Chennai
TAMIL NADU |
9841108873
drvetri@bewellhospitals.com |
| DrV Dedeepiya Devaprasad |
Dedeepiyas Clinic |
Room No 1, Department of Clinical Research,
17/8, Dr. Natesan Road, Triplicane
Chennai-600005
Chennai
TAMIL NADU |
9444216333
dedeepiya_76@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Universal Ethics Committee (A Unit of Aurous HealtCare Research and Development India Pvt. Ltd ) |
Approved |
| Universal Ethics Committee (A Unit of Aurous HealtCare Research and Development India Pvt. Ltd ) |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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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
|
| Type |
Name |
Details |
| Intervention |
Nichi Glucan AFO-202 and N-163 |
Dose: Nichi Glucan AFO-202 and N-163
Dosage: 1 sachet of Nichi Glucan AFO-202 and N-163 to be consumed with water 30 minutes after meal.
Treatment Duration: 60 days per enrolled subject
Route of Administration: Oral
|
| Comparator Agent |
None. Conventional Therapy considered as control. |
None. Conventional Therapy considered as control. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult subjects aged between 18 and 55 years both ages, all sexes inclusive diagnosed with NAFLD
2. Subjects with NAFLD Activity Score greater than or equal to 3 and FIB-4 cut offs of greater than 1.3 and less than 3.25 as diagnosed by USG.
3. Subjects who have no history of substance abuse specifically alcohol.
4. Subjects who dont consume alcoholic beverages-Men more than 4 per day pr 17 per week;Women-3 per day or 7 per week.
5. Subjects may have diabetes mellitus.
6. Subject/LAR who is willing to give written informed consent for participation, able to comprehend and understand the responsibilities during treatment period.
7. Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with history that suggests possible allergic reaction to the investigational product.
2. Subjects who have a history or an active diagnosis of any hepatic infection not limited to Hepatocellular Carcinoma, HCV, HBV, congenital or liver disease of any etiology.
3. Subjects with AST, ALT 5 times ULN.
4. Subjects who have undergone surgical procedures on the liver, not limited to liver transplant, liver resection, hepatic lobotomy.
5. Subjects with billary duct obstruction on the basis of ultrasound.
6. Subjects with a history of gastrointestinal bypass or current use of drugs known to cause hepatic steatosis eg., aminodarone, valproate, tamoxifen, methotrexate, steroids etc.
7. Subjects who have difficulty in swallowing or any condition that makes per oral medication difficult or impossible.
8. Subjects who have undergone major surgical procedure 4 weeks prior to randomization.
9. Subjects with history or current diagnosis or autoimmune diseases, immunocompromised states.
10. Subjects with CKD or other diseases that impair normal kidney function.
11. Subjects who are on anti-depressants, anti-psychotics or presenting in psychiatric condition that would interferen with the parameters of the clinical study.
12. Subjects with known history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory or genitourinary abnormalities or diseases; except those that are considered etiology or co-morbid to the study indication.
13. Females who are pregnant or lactating or planning to become pregnant during the study period.
14. Subjects who are currently participating or have participated in a clinical trial upto 90days prior to randomization.
15. Subjects, who in the opinion of the investigator are unsuitable for enrolment.
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| 1. Translent Elastography(TE) : Improvement in fatty liver based on reduction in Ultrasound Attenuation Parameter(UAP |
1. Translent Elastography(TE) : Day 1, Day 30 and Day 60. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1. For DM2 Cohort Only: Fasting Blood Glucose: 70-125 mg/dL or greater than or equal to 10% reduction from baseline.
2. For DM2 Cohort Only: Post Prandial Glucose: 140-199 mg/dL or greater than or equal to 30% reduction from baseline.
3. For DM2 Cohort Only: HbA1C: 5.7-6.4% A1C levels.
4. For DM2 Cohort Only: HbA1C: lesser than 5.7% A1C levels.
5. Fasting Lipid Profile: Greater than or equal to 30%improvement.
6. Safety Investigations: hsCRP, Complete Blood Count.
|
1. For DM2 Cohort Only: Fasting Blood Glucose: Day 1, Day 30 and Day 60.
2. For DM2 Cohort Only: Post Prandial Glucose: Day 1, Day 30 and Day 60.
3. For DM2 Cohort Only: HbA1C: Day 1, Day 30 and Day 60.
4. For DM2 Cohort Only: HbA1C: Day 1, Day 30 and Day 60.
5. Fasting Lipid profile: Day 1, Day 30 and Day 60.
6. Safety Investigation: hsCRP, Complete Blood Count: Day 1, Day 30 and Day 60.
|
|
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Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/11/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Study Design : An Open Label, Prospective, Randomised, Comparative, Two Arm
Clinical Study
Indication : NAFLD
Investigational
Product : Nichi
Glucan AFO-202 and N-163
Comparator: None. Conventional Therapy
considered as control
Dose/Dosage: Nichi Glucan AFO-202 and N-163.
1 sachet of Nichi
Glucan AFO-202 and N-163 to be consumed with water 30 minutes after meal
Subject
Population: 12
Number of
Subjects: 12 Evaluable Subjects
Treatment Arms:
Two Treatment Arms
Treatment Arm
I: Conventional
Therapy
Treatment Arm
II: Nichi Glucan
AFO-202 and N-163 plus Conventional Therapy
Treatment
Duration: 60 Days
Assessments
1. Translent
Elastography(TE) : Day 1, Day 30 and Day 60.
2. For DM2 Cohort
Only: Fasting Blood Glucose: Day 1, Day 30 and Day 60.
3. For DM2 Cohort
Only: Post Prandial Glucose: Day 1, Day 30 and Day 60.
4. For DM2 Cohort
Only: HbA1C: Day 1, Day 30 and Day 60.
5. For DM2 Cohort
Only: HbA1C: Day 1, Day 30 and Day 60.
6. Fasting Lipid
profile: Day 1, Day 30 and Day 60.
7. Safety
Investigation: hsCRP, Complete Blood Count: Day 1, Day 30 and Day 60.
Background of
the study: Fatty
liver is a common condition caused by having too much fat build up in your
liver. A healthy liver contains a small amount of fat, it becomes a problem
when fat reaches 5% to 10% of livers weight. There is no medication specifically
for fatty liver but lifestyle changes that can significantly improve your
health. An alternative treatment with nutritional supplements with higher level
of safety and effectiveness are needed.
Purpose of the
Study : Nichi Glucan is a food supplement it contains
two variants one from strain AFO-202 and other from strain-163.Nichi Glucan has
a unique structural formula compared to other 1,3-1,6 Beta glucans. Based on
its effects maintaining blood glucose and lipid levels and also fatty liver
diseases. This clinical study is done to evaluate
the safety, efficacy and tolerability of Two Strains of Nichi Glucan AFO-202 and N-163 as an Add
on Therapy in Comparison with Conventional Therapeutic Regimen in Adult
subjects with NAFLD.
|