| CTRI Number |
CTRI/2020/06/025527 [Registered on: 01/06/2020] Trial Registered Prospectively |
| Last Modified On: |
23/02/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Siddha |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical trial on Immunity and antiviral for quarantine patients of COVID-19 |
Scientific Title of Study
Modification(s)
|
“A Prospective, Open label, Randomized-controlled study to evaluate the efficacy and safety of Amrta Karuna Syrup in mildly symptomatic COVID- 19 patients†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CT/Vopec/Amrta Karuna /2020 version 1.0 dated 24th Apr 2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dinesh |
| Designation |
Chief Scientific office |
| Affiliation |
Vopec Pharmaceuticals (P) Ltd |
| Address |
B-13, Mogappair Industrial Estate,
Mogappair West,
Chennai
Chennai
TAMIL NADU
600 037
India |
| Phone |
9952063729 |
| Fax |
|
| Email |
rnd@vopecpharma.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinesh |
| Designation |
Chief Scientific office |
| Affiliation |
Vopec Pharmaceuticals (P) Ltd |
| Address |
B-13, Mogappair Industrial Estate,
Mogappair West,
Chennai
Chennai
TAMIL NADU
600 037
India |
| Phone |
9952063729 |
| Fax |
|
| Email |
rnd@vopecpharma.com |
|
Details of Contact Person
Public Query
|
| Name |
DrDinesh |
| Designation |
Chief Scientific office |
| Affiliation |
Vopec Pharmaceuticals (P) Ltd |
| Address |
B-13, Mogappair Industrial Estate,
Mogappair West,
Chennai
Chennai
TAMIL NADU
600 037
India |
| Phone |
9952063729 |
| Fax |
|
| Email |
rnd@vopecpharma.com |
|
|
Source of Monetary or Material Support
|
| Vopec Pharmaceuticals Pvt Ltd
B-13, Mogappair Industrial Estate,
Mogappair West,
Chennai - 600 037. |
|
|
Primary Sponsor
|
| Name |
Vopec Pharmaceuticals Pvt Ltd |
| Address |
B-13, Mogappair Industrial Estate, Mogappair West, Chennai - 600 037. |
| 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 CR Jayanthi |
Bangalore Medical College and Research Institute |
Department of general medicine OPD Room no:2 1st floor Fort, Krishna Rajendra Rd, Bengaluru, Karnataka 560002
Bangalore
KARNATAKA |
08026701529
bmccrj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics commitee-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 |
| Intervention |
Amrta Karuna Syrup |
Dosage Form: syrup
Dose: 15 ml
Frequency: 2 times daily after meal
Route of administration: oral
Duration of therapy: 14 days
|
| Comparator Agent |
Standard treatment as per
hospital protocol for COVID 19 |
Cases of COVID 19 shall be
treated with standard treatment
as per hospital protocol for
COVID 19 until the recovery
Day 1 to Day 14 Route : Orally
twice daily after meal As per the
Hospital guidelines. Route :
Orally Dose: As per standard
Hospital policy |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects age group 18 - 65 years both gender
2.Patients diagnosed with COVID-19 positive mild symptomatic patients (Confirmed by RTPCR) - Patients with uncomplicated upper respiratory infection
a. Spo2>94% in room air
b. Respiratory rate <24 per min
c. No evidence of hypoxaemia or
breathlessness
3. Subjects willing to give a written informed consent and come for a regular follow up
4. Subject willing to abide by and comply with the study protocol
|
|
| ExclusionCriteria |
| Details |
i.Presence of acute hypoxic respiratory failure.
ii.Intensive care unit (ICU) stay.
iii. Patients who need mechanical ventilation.
iv.Category 6 or 5 based on modified 7-category ordinal scale of clinical status |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
To Evaluate The Safety And Efficacy Of Amrta Karuna syrup In mildly symptomatic COVID- 19 patients
|
Day 0 to 14 |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1.LDH, TLC, CRP, D-DIMER and RT PCR from baseline to end of the study i.e. 14 days.
2.RT PCR test will do Day 0,Day 7 and Day 10
|
Day 0,Day 7,Day 10 and Day 14 |
|
Target Sample Size
Modification(s)
|
Total Sample Size="42"
Sample Size from India="42"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/06/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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
|
Amrta Karuna Syrup is a polyherbal formulation which is a
potent combination of antivirals, antibacterials and anti inflammatory along
with adaptogen and rejuvenating ingredients Morinda tinctoria, Azadirachta
indica, Aegle marmalades, Tamarindus indica, have been suggested in the
treatment.
Administration of formulation of the present
invention was found to stimulate immunological activity in in vitro cell
culture studies. Treatment with five doses of formulation of the present
invention was found to enhance the total amount of cytokines production count.
Anti inflammatory cytokine such as IL-4,
IL-6, IL-10, IFN gamma are produced in significant amount and estimated using
quantitative method. These results confirm the immunomodulatory activity of composition
of the present invention |