CTRI Number |
CTRI/2020/06/025592 [Registered on: 04/06/2020] Trial Registered Prospectively |
Last Modified On: |
19/09/2020 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda |
Study Design |
Single Arm Trial |
Public Title of Study
|
Use of Herbal Medicine likeTulasi,Amruth(Giloy), Turmeric,Ashwagandha as add on treatment in COVID-19 Patients |
Scientific Title of Study
|
A clinical Study to Evaluate the Role of Herbal Immunomodulators as add on Treatment in Asymptomatic and Mildly Symptomatic COVID-19 Confirmed Cases. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
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 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 Public Query
|
Name |
Dr M Ravi Kumar Reddy |
Designation |
Chief Scientific Officer |
Affiliation |
Sri Sri Tattva |
Address |
Sriveda Sattva Pvt Ltd
54/56 39th A Cross 11th Main Road 4th TBlock
Jayanagar Bangalore Karnataka India 560041
Bangalore KARNATAKA 560041 India |
Phone |
9346857001 |
Fax |
|
Email |
dr.ravireddy@srisritattva.com |
|
Source of Monetary or Material Support
|
Sriveda Sattva PvtLtd
54/56 39th A Cross 11th Main Road 4th T Block Jayanagar Bangalore Karnataka
India 560041 |
|
Primary Sponsor
|
Name |
Sri Sri Tattva |
Address |
Sriveda Sattva PvtLtd
54/56 39th A Cross11th Main Road 4th T BlockJayanagarBangaloreKarnatakaIndia560041 |
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 |
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 |
Immunity Kit |
Shakti drops:
Dosage: 5 drops 3 times a day (Morning/ Afternoon/Night)
Amruth tablet:
Dosage: 1 tablet 2 times a day
Turmeric plus tablet::
Dosage: 1 tablet 2 times a day
Tulsi arka:
Dosage: 10 drops 3 times a day (Morning/ Afternoon/Night) |
Comparator Agent |
Not applicable |
Not applicable |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Confirmed Asymptomatic and mildly symptomatic cases of COVID-19 infection by laboratory tests
Age limit 18 to 60 years both Male and Female
Uncomplicated cases of COVID - 19 patients on Allopathic medication
Patients in whom ventilator support is not required
Patients with no associated co morbidities
Patients willing to give informed consent to participate in the clinical trial |
|
ExclusionCriteria |
Details |
COVID-19 positive patients above 60 years of age & below 18 years with Symptoms.
Patients with associated comorbidities like hypertension, type 2 or type 1 diabetes mellitus, chronic or acute renal failure
Patients on Immuno-suppression therapy
Pregnant Women or lactating mothers Patients in advanced stage of disease requiring emergency medical intervention like pneumonia, bronchial asthma, organ failure
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Early recovery in the signs and symptoms of cases of Asymptomatic and mild symptomatic COVID-19 patients by adding Ayurvedic medicines which are effective in enhancing immunity of body and reducing the symptoms such as Fever and respiratory distress |
Day 1 and Day 30 |
|
Secondary Outcome
|
Outcome |
TimePoints |
a. TNF-α
b. IL-6
c. IFN- β
d. IFN-λ |
Day 1 and Day 30 |
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
Phase of Trial
|
Phase 3/ Phase 4 |
Date of First Enrollment (India)
|
13/06/2020 |
Date of Study Completion (India) |
11/07/2020 |
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
|
Not yet finalised on the journal in which the data from the current study would be published. |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Title: A clinical Study to Evaluate the role Herbal Immunomodulators as add on Treatment in Asymptomatic and Mildly Symptomatic COVID-19 Confirmed Cases. This open Label, Comparative Interventional study,conducted among 50 asymptomatic and mildly symptomatic COVID-19 confirmed patients using Ayurveda Drugs :SHAKTI DROPS: Dosage: 5 drops 3 times a day (Morning/ Afternoon/Night) AMRUTH TABLET: Dosage: 1 tablet 2 times a day TURMERIC PLUS TABLET: Dosage: 1 tablet 2 times a day TULSI ARKA: Dosage: 10 drops 3 times a day (Morning/Afternoon/ Night). Inclusion Criteria: Confirmed Asymptomatic and mildly symptomatic cases of COVID-19 infection by laboratory tests Age limit 18 to 60 years both Male and Female Uncomplicated cases of COVID - 19 patients on Allopathic medication Exclusion Criteria: COVID-19 positive patients above 60 years of age & below 18 years with Symptoms. Patients with associated comorbidities like hypertension, type 2 or type 1 diabetes mellitus, chronic or acute renal failure Patients on Immuno-suppression therapy Pregnant Women or lactating mothers Patients in advanced stage of disease requiring emergency medical intervention like pneumonia, bronchial asthma, organ failure
Site: Bangalore Medical college and research institute Primary Outcome: Early recovery in the signs and symptoms of cases of Asymptomatic and mild symptomatic COVID-19 patients by adding Ayurvedic medicines which are effective in enhancing immunity of body and reducing the symptoms such as Fever and respiratory distress on Day 1 and Day 30 Seconadry Outcome:TNF-α, IL-6, IFN- β, IFN-λ on Day 1 and Day 30 |
|