| 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. 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 |
|