| CTRI Number |
CTRI/2021/03/031815 [Registered on: 09/03/2021] Trial Registered Prospectively |
| Last Modified On: |
04/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
An Anti-Viral Ayurvedic formulation for the treatment of COVID-19 Patients |
|
Scientific Title of Study
|
A clinical study to evaluate the effect of livance-c, an anti-viral ayurvedic formulation for the treatment of covid-19 patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sandeep Dandin |
| Designation |
Principal Investigator |
| Affiliation |
Belgaum Institute of Medical sciences, Belgaum 590 010 |
| Address |
Department of Respiratory Medicine,Belgaum Institute of Medical sciences, Belgaum 590 010,India
Belgaum
KARNATAKA
590010
India |
| Phone |
9763203839 |
| Fax |
|
| Email |
sandeepraghavendra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vedantam Giridhar |
| Designation |
Research Coordinator |
| Affiliation |
Shri B. M. Kankanawadi Ayurved Mahavidyalaya |
| Address |
Central Research Facility & Reader Department of Dravyaguna KLE Shri B. M. Kankanawadi Ayurved Mahavidyalaya KLE Academy of Higher Education & Research
Belagavi Karnataka 590003
Belgaum
KARNATAKA
590003
India |
| Phone |
919731028625 |
| Fax |
|
| Email |
drgiridharay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R G Viveki |
| Designation |
Member Secretary of IEC |
| Affiliation |
Belgaum Institute of Medical sciences, Belgaum 590 010 |
| Address |
Dept. Institutional Ethics Committee Belgaum Institute of Medical sciences, Belgaum 590 010,India
Belgaum
KARNATAKA
590010
India |
| Phone |
|
| Fax |
|
| Email |
drrgviveki@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Respiratory Medicine,Belgaum Institute of Medical sciences, Belgaum 590 010,India |
|
|
Primary Sponsor
|
| Name |
Avance Phytotherapies Pvt Ltd |
| Address |
3, Sarkhej - Gandhinagar Hwy, Ghatlodiya, Sarkhej, Ahmedabad, Gujarat 380055 |
| 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 Sandeep Dandin |
Belgaum Institute of Medical sciences |
Department of Respiratory Medicine,Belgaum Institute of Medical sciences, Belgaum 590 010,India
Belgaum
KARNATAKA |
9763203839
sandeepraghavendra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BELAGAVI INSTITUTE OF MEDICAL SCIENCE, BELAGAVI |
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 |
Livance C Capsule |
Livance C 400mg Capsule Twice daily for 15 days |
| Comparator Agent |
Mono-Therapy |
hydroxycholroquine 400 mg Twice a daily for 10 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Freshly detected and confirmed positive (by means of RT-PCR) COVID-19 patients requiring admission.
Patients on whom no other (specifically targeted to treat COVID-19) treatment has been initiated. (Patients on supportive care can be considered for inclusion).
Patients who have consented (written informed consent) to be treated
with the trial drug as the primary treatment.
Patient is in the age group between 18-65years.
Patient has persistent fever ≥99.50 F and is currently maintained on
antipyretics.
Patient is unable to take a deep breath and/ or not able to hold for ≥ 20
seconds.
Patient has a history of cough since ≥ 3 days.
Patient has a history of body aches or tiredness or unusual fatigue lately
(≥ 7 days).
Patients ability in the investigators opinion to comply with the protocol
procedures. |
|
| ExclusionCriteria |
| Details |
•Suspected patients with COVID19, but not confirmed by RT-PCR test.
•Confirmed positive Patient on whom already alternative medical treatment has been initiated.
•History of tuberculosis.
•History / evidence of allergy or hypersensitivity to Hydroxychloroquine sulfate or of herbal drugs or to any of the inactive ingredients of the formulation or to any other drug.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of the time taken from initiation of the study treatment to the day of discharge. Discharge criteria is defined as a negative RT-PCR test for respiratory tract samples (nasopharynx and throat swabs) and re-confirmed after at least 24 hours |
Day -01 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
A. Time to clinical improvement (TCI), defined as the time to normalization of initial symptoms:
B. Safety and tolerability, as assessed by adverse effects.
|
-No fever (95.5oF) for 3 days without the use of antipyretics
-Day 07
-Day 14
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/03/2021 |
| 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="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is designed to check the safety & efficacy of LIVANCE-C, An anti-viral ayurvedic formulation for the treatment of COVID-19 patients.
Primary objective: Assessment of the time taken from initiation of the study treatment to the day of discharge. Discharge criteria are defined as a negative RT-PCR test for respiratory tract samples (nasopharynx and throat swabs) and re-confirmed after at least 24 hours. Secondary objective: A. Time to clinical improvement (TCI), defined as the time to normalization of initial symptoms:
B. Safety and tolerability, as assessed by adverse effects. |