| CTRI Number |
CTRI/2021/10/037380 [Registered on: 20/10/2021] Trial Registered Prospectively |
| Last Modified On: |
19/10/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical Study on Nichi Glucan to Verify Effectiveness on Covid19 |
|
Scientific Title of Study
|
An Open Label, Prospective, Randomized, Comparative, Multiple Arm Clinical Study to Evaluate the Immunomodulatory Efficacy of Nichi Glucan in Comparison with Conventional Therapeutic Regimen in Adult Subjects with Covid-19 caused by SARS-COV2 (B-COV) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| F25S/MGR/MMC/Nichi Glucan; Ver No 1.1 dated 01-Sep-21 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pushkala S |
| Designation |
Principal Investigatir |
| Affiliation |
The Tamil Nadu Dr. MGR Medical University |
| Address |
Department of Immunology,
No 69, Anna Salai Rd
Guindy
Chennai
Chennai
TAMIL NADU
600032
India |
| Phone |
9940223180 |
| Fax |
|
| Email |
pushkala.s@tnmgrmu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pushkala S |
| Designation |
Principal Investigatir |
| Affiliation |
The Tamil Nadu Dr. MGR Medical University |
| Address |
Department of Immunology,
No 69, Anna Salai Rd
Guindy
Chennai
Chennai
TAMIL NADU
600032
India |
| Phone |
9940223180 |
| Fax |
|
| Email |
pushkala.s@tnmgrmu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Gurunathan K S |
| Designation |
Trial Coordinator |
| Affiliation |
The Tamil Nadu Dr. MGR Medical University |
| Address |
Department of Immunology,
No 69, Anna Salai Rd
Guindy
Chennai
Chennai
TAMIL NADU
600032
India |
| Phone |
9042932009 |
| Fax |
|
| Email |
srigurug@gmail.com |
|
|
Source of Monetary or Material Support
|
| GN Corporation Co Ltd
3-8 Wakamatsu, Kofu
Yamanashi Prefecture 400 0866
Japan |
|
|
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
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pushkala S |
Madras Medical College (Affiliated to the Tamil Nadu MGR Medical University) |
Department of Immunology
Room no 1, Poonamallee High Road Town, Chennai 600003
Chennai
TAMIL NADU |
9042932009
pushkala.s@tnmgrmu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Madras Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nichi Glucan and Conventional Therapy |
Dose
Nichi Glucan -AFO-202- 1 g
Nichi Glucan Refix -N-163-10g
Dosage
Nichi Glucan -AFO-202- 1 g sachets thrice daily with meals
Nichi Glucan Refix -N-163-10g gel sachet once daily
Treatment Duration - 60 days
Route of Administration - Oral
|
| Comparator Agent |
None |
None. Conventional Therapy to be used |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult subjects between 18 and 65 years -both ages and sexes-inclusive- who are confirmed to be positive for SARS-CoV2 by way of RT-PCR in a laboratory approved by MoH-FW and the State Government.
2. Patients with co-morbidities can be included.
3. Patients who are found to be Covid19 positive requiring hospitalization. -Symptomatic or asymptomatic-
4. Patients and LAR who is willing to give informed consent for participation, able to comprehend and understand the responsibilities during treatment period.
5. Patients who are willing not to participate in any other clinical trial during participation in the current trial.
|
|
| ExclusionCriteria |
| Details |
1. Patients who are known to be HIV, HBV, HCV positive.
2. Patients who have clinically abnormal renal or hepatic function values that are 3x times normal upper limit or in the opinion of the Investigator would impact the objectives of the study.
3. Patients with complete cancer remission less than 3 years prior to the date of screening.
4. Patients who have undergone major surgical procedure 4 weeks prior to randomization.
5. Patients who are on anti-depressants, anti-psychotics.
6. Patients with known history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases; expect those that are considered etiology of said indication
7. Females who are pregnant or nursing or planning to become pregnant during the study period. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Immunology: IL-2, IL6, IgA
2. Hospitalisation: Mortality, Duration of hospital stay, Need for Oxygen or Life-support
3. Blood Test :Complete blood count –CBC-, D-Dimer, C-reactive protein –CRP-, Erythrocyte Sedimentation rate –ESR-, Fasting –FBG- and post-prandial –PPG- blood glucose, HbA1C, Lipid profile, Liver function test, Ferritin
|
Day 0, Day 7, Day 15, Day 30, Day 60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| COVID-19 Clinical Symptoms: Time taken for improvement, complete recovery, recurrence in typical symptoms not limited to pyrexia, respiratory distress, cephalic, malaise from baseline. |
Day 0, Day 7, Day 15, Day 30, Day 60 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
25/10/2021 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study Design: An Open Label, Prospective, Randomized, Comparative Clinical Study
Indication: Covid-19
Investigational Product: Conventional Therapy and Nichi Glucan -AFO-202- and Nichi Glucan Refix -N-163
Comparator: Conventional Therapy Dose
Nichi Glucan -AFO-202- 1 g
Nichi Glucan Refix -N-163-10g Dosage
Nichi Glucan -AFO-202- 1 g sachets thrice daily with meals
Nichi Glucan Refix -N-163-10g gel sachet once daily Subject Population-Adult subjects between 18 and 65 years -both ages and sexes-inclusive- who are confirmed to be positive for SARS-CoV2 by way of RT-PCR in a laboratory approved by MoH-FW and the State Government.
Number of Subjects: 100 Evaluable Subjects Treatment Arms
Group I: Standard treatment (Control) 50 Subjects
Group II: Standard treatment along with food supplement Nichi Glucan AFO-202 -1 g sachet thrice daily with meals- and N-163 -10g gel sachet once daily (50 Subjects)
Treatment Duration : 60 days per enrolled subject Assessments
Blood Tests
Complete blood count –CBC-,
D-Dimer,
C-reactive protein –CRP-,
Erythrocyte Sedimentation rate –ESR-,
Fasting –FBG- and post-prandial –PPG- blood glucose, HbA1C,
Lipid profile,
Liver function test,
Ferritin
Tests on Day 0 and repeated on Day 15, Day 30 and Day 60 COVID-19 Clinical Symptoms
Time taken for improvement, complete recovery, recurrence in typical symptoms not limited to pyrexia, respiratory distress, cephalic and malaise -Day 0 and repeated on Day 15, Day 30 and Day 60 Background of the study: The ongoing COVID-19 pandemic caused by the novel Corona virus CoV strain -2019-nCoV-, termed severe acute respiratory syndrome CoV-2 -SARS-CoV-2- has led to 205,338,159 confirmed cases of COVID-19, including 4,333,094 deaths, worldwide. Current supportive care measures such as ventilation oxygenation and fluid management remain the standard of care. Current pharmacological treatment can provide partial or complete recovery despite their adverse effects. An alternative treatment with food supplements with higher level of safety and effectiveness are needed. Purpose of the Study: Nichi Glucan is a food supplement containing 1,3-1,6 Beta Glucan which is a dietary fiber obtained from a black yeast known as the Aureobasidium pullulans strains AFO- 202- Nichi Glucan- and N-163 -Nichi Glucan Refix-. Nichi glucan has many beneficial effects on improving metabolism, boosting immunity, maintaining blood sugar levels etc. This clinical study is done to evaluate the Immunomodulatory Efficacy of Nichi Glucan in Comparison with Conventional Therapeutic Regimen in Adult Subjects with Covid-19 caused by SARS-COV2 (B-COV) |