| CTRI Number |
CTRI/2020/12/030051 [Registered on: 28/12/2020] Trial Registered Prospectively |
| Last Modified On: |
30/10/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
ImmunoModulatory Efficacy of Nichi Glucan in Covid19 Patients. |
|
Scientific Title of Study
|
An Open Label, Prospective, Randomised, Comparative, Two 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 |
| NBS/YSD/AHC/F9S/COVID Version 01 Dated 17-Sep-20 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr R Senthilkumar |
| Designation |
Director |
| Affiliation |
Medi Nippon Health Care Private Limited |
| Address |
No.6, Zakariah Colony III St., Choolaimedu Chennai 600 094
Chennai
TAMIL NADU
600094
India |
| Phone |
9444083550 |
| Fax |
|
| Email |
mail@medinippon.jp |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Senthilkumar |
| Designation |
Director |
| Affiliation |
Medi Nippon Health Care Private Limited |
| Address |
No.6, Zakariah Colony III St., Choolaimedu Chennai 600 094
TAMIL NADU
600094
India |
| Phone |
9444083550 |
| Fax |
|
| Email |
mail@medinippon.jp |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Senthilkumar |
| Designation |
Director |
| Affiliation |
Medi Nippon Health Care Private Limited |
| Address |
No.6, Zakariah Colony III St., Choolaimedu Chennai 600 094
TAMIL NADU
600094
India |
| Phone |
9444083550 |
| Fax |
|
| Email |
mail@medinippon.jp |
|
|
Source of Monetary or Material Support
|
| Nichi-In Biosciences Pvt Ltd |
| Yashoda Hospitals, Hyderabad |
|
|
Primary Sponsor
|
| Name |
Medi Nippon Health Care Private Limited |
| Address |
No.6, Zakariah Colony III St., Choolaimedu Chennai 600 094 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Naveen Reddy |
Yashoda Hospitals |
Department of General Medicine,
Yashoda Hospitals,
Bhavan Road, Matha Nagar, Somajiguda, Hyderabad, Telangana 500082
Hyderabad
TELANGANA |
04045674567
drnaveenreddy@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Yashoda Academy of Medical Education & Research, Yashoda Hospital |
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 |
Nichi Glucan is provided along with Conventional Therapy
Dose : 0.5 g x 6 sachets per day – 3 gm; 2 sachets to be taken 30 minutes after a meal thrice daily
Duration : 30 Days
Route of Administration : Oral |
| Comparator Agent |
None. Only Conventional Therapy to be provided. |
None. Only Conventional Therapy to be provided. |
|
|
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. Subjects with co-morbidities can be included. To be analysed as cohort.
3. Subjects who are found to be Covid19 positive requiring hospitalization. (symptomatic or asymptomatic)
4. Subject and LAR who is willing to give informed consent for participation, able to comprehend and understand the responsibilities during treatment period.
5. Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
|
|
| ExclusionCriteria |
| Details |
1. Subjects who have previously been infected with SARS-CoV2 (symptomatic or asymptomatic) and recovered.
2. Subjects who are known to be HIV, HBV, HCV positive.
3. Subjects 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.
4. Subjects with complete cancer remission less than 3 years prior to the date of screening.
5. Subjects who have undergone major surgical procedure 4 weeks prior to randomisation.
6. Subjects who are on anti-depressants, anti-psychotics.
7. 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 of said indication.
8. 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. Covid19 Clinical Symptoms: Time taken for improvement, complete recovery, recurrence in typical symptoms not limited to pyrexia, respiratory distress, cephalgia, malaise from baseline.
2. RT PCR: Time taken for negative RT PCR Result from baseline.
3. RT PCR : Reduction of titer/severity level from baseline. |
Covid19 Clinical Symptoms: Day 1, Day 15, Day 30
RT PCR: Day 1, Day 15, Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Immunology : CD4, CD8, CD56, CD13, IgA, IL6
Hospitalisation : Mortality, ICU admission, Oxygen/LifeSupport
Blood Test : D-Dimer, CRP, ESR, FBG
Chest Scan : CT Lung
QoL Questionnaire |
Immunological Parameters: Day 1, Day 15, Day 30
Hospitalization parameters: Day 15, Day 30
Blood Parameters: Day 1, Day 15, Day 30
Chest Scan: Day 1, Day 15, Day 30
Quality of life Questionnaire : Day 15, Day 30
|
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
05/01/2021 |
| 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="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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, Randomised, Comparative, Two
Arm Clinical Study
Investigational Product : Nichi Glucan
Comparator : None. Conventional Therapy only to be provdied.
Indication : Covid19 caused by SARS-COV2 (beta COV)
Subject Population : Adult Subjects aged between 18 and 65 years ( both
ages all 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 : 48 Subjects
Treatment Arms : Two
Treatment Arm I : Nichi Glucan + Conventional Therapy : 24 Subjects
Treatment Arm II : Conventional Therapy : 24 Subjects
Treatment Duration : Maximum of 30 days per enrolled Subject
Assessments
1. Covid19 Clinical Symptoms : Day 1, Day 15, Day 30
2. RT PCR : Day 1, Day 15, Day 30
3. Immunological Parameters : Day 1, Day 15, Day 30
4. Hospitalisation Parameters : Day 1, Day 15, Day 30
5. Blood Parameters : Day 1, Day 15, Day 30
6. Chest Scan : Day 1, Day 15, Day 30
7. Quality of Life Questionnaire : Day 15, Day 30 |