| CTRI Number |
CTRI/2020/06/025801 [Registered on: 10/06/2020] Trial Registered Prospectively |
| Last Modified On: |
14/10/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of Herbal Immunomodulators in mild COVID-19 confirmed cases |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the role of Herbal Immunomodulators (Tab Septilin and Tab Bresol) as add on treatment in Asymptomatic and mildly symptomatic COVID-19 confirmed cases |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HDC/CP/PP/037/2020 Version 1.0 Dated 07 May 2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr C R Jayanthi |
| Designation |
Director cum Dean BMCRI |
| Affiliation |
Bangalore Medical College research Institute |
| Address |
Bangalore Medical College research Institute Fort KR Road
Bengaluru Department of COVID-19, Division - Isolation ward Room
number - 1
Bangalore
KARNATAKA
560002
India |
| Phone |
9448292424 |
| Fax |
|
| Email |
bmccrj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Palaniyamma D |
| Designation |
Principal Scientist-Scientific Strategy |
| Affiliation |
The Himalaya Drug Company |
| Address |
Room No 301,3rd Floor
Clinical
Phramacology.
Reserach and Development Makali,Tumkur Road,
Bangalore Rural
KARNATAKA
562162
India |
| Phone |
|
| Fax |
|
| Email |
dr.palani@himalayawellness.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soorya Narayan H |
| Designation |
Clinical Trial Manager |
| Affiliation |
The Himalaya Drug Company |
| Address |
Room No 301,3rd Floor
Clinical
Phramacology.
Reserach and Development Makali,Tumkur Road,
Bangalore Rural
KARNATAKA
562162
India |
| Phone |
|
| Fax |
|
| Email |
dr.sooryanarayan.h@himalayawellness.com |
|
|
Source of Monetary or Material Support
|
| The Himalaya Drug Company.
Makali, Makali Aluru Main Rd, Opp JCB, Bengaluru, Karnataka 562162 |
|
|
Primary Sponsor
|
| Name |
The Himalaya Drug Company |
| Address |
The Himalaya Drug Company Makali, Tumkur Road, Bangalore |
| 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 C R Jayanthi |
Bangalore Medical college and research institute |
Department of
COVID-19, Division -
Isolation ward Room
number - 1 Fort KR
road, Bangalore
Bangalore
KARNATAKA |
9448292424
bmccrj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Bangalore Medical College and Research Institute |
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 |
| Comparator Agent |
Not applicable |
Not Applicable |
| Intervention |
Tab. Bresol and Tab. Septilin |
Each tablet is recommended at a dose of 1 tablet twice daily orally (BD) for the specified duration of treatment (from day 1 upto14 days from the discharge from the hospital, as applicable). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects who are COVID-19 confirmed cases, with mild severity presenting with signs and symptoms qualifying for Low Clinical Risk (News Scoring 0-4)
2. Subjects with SARS-CoV-2 RT-PCR confirmed COVID-19 positive within 7 days from symptom onset or Patients within 48 hours after laboratory diagnosis (SARS-CoV-2 RT-PCR).
3.Female of childbearing potential willing to follow reliable and strict contraceptive measures.
4.Subject judged to be reliable for compliance for taking medication and capable of recording the effects of the medication and motivated in receiving benefits from the treatment and compliance to quarantine procedure (as per prevailing guidelines).
5. Able to give written inform consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1.Confirmed COVID-19 positive cases with NEWS scoring system ≥5.
2.Individual with acute respiratory distress presenting with RR> 24/mt, SaO2/SPO2≤94% in room air condition, or the Pa02/Fi02 ratio <300mgHg.
3.Pregnant or breastfeeding females.
4.Recent history of significant lung disease like Asthma or Chronic Obstructive Lung Disease (COPD).
5.Unable to take oral medication or suffering from ailments related to absorption.
6.Suffering from Immunocompromising conditions or taking any immunosuppressing therapy.
7.Subjects suffering from severe and uncontrolled metabolic, endocrinal, cardiac/ renal/liver disease.
8.The subject with known hypersensitivity to any of the test materials or related compounds.
9.The subject who are unable or unwilling to comply fully with the study protocol.
10.Physician makes a decision that trial involvement is not in patients best interest, or any condition that does not allow the protocol to be followed safely.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time to Clinical Recovery
No. & Percentage (%) of subjects converting into severe cases.
Time to convert 2019 nCoV RT PCR in negative in upper respiratory tract specimen
Lenth of Hospital stay
Proportion of clinical failure -ICU admission, mechanical ventilation or death
Number & Percentage (%) of subjects converting into positive test for COVID-19
Protection as defined by various laboratory parameters related to inflammation and immunity
Overall well-being |
Visit-1 Baseline
Visit-2 Date of discharge
Visit-3(Telephonic) 7 days from the date of discharge±1day
Visit-4 14 days from the date of discharge ±3day
(EOS) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
No. & Percentage (%) of subjects having recurrence of COVID-19 within two weeks after discharge
cases.
Incidence of any opportunistic infection
Incidence of adverse effects
Study Drug Compliance |
Visit-1 Baseline
Visit-2 Date of discharge
Visit-3(Telephonic) 7 days from the date of discharge±1day
Visit-4 14 days from the date of discharge ±3day
(EOS) |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
19/06/2020 |
| Date of Study Completion (India) |
25/08/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A Clinical Study to Evaluate the role of Herbal Immunomodulators (Tab Septilin and Tab Bresol) as add on treatment in Asymptomatic and mildly symptomatic COVID-19 confirmed cases |