| CTRI Number |
CTRI/2020/06/026187 [Registered on: 26/06/2020] Trial Registered Prospectively |
| Last Modified On: |
26/06/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical trial of herbal supplement as an immunomodulator in adult Covid 19 positive patients. |
|
Scientific Title of Study
|
Phase II, open label, randomized controlled trial to evaluate Safety and Efficacy of ACT12 Tablet and ACT 13 dry syrup as an immunomodulator in adult Covid 19 positive patients |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PROTOCOL NO- MHC/CT/20-21/002 Ver. 2.0, Dated 3rd June 2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tushar V Patil |
| Designation |
Principle Investigator |
| Affiliation |
YCM Hospital, Pimpri, Pune 18. |
| Address |
Head of Department-Pathology, 1st floor, Room No. 127,Pimpri chinchwad Municiple Corporations YCM Hospital, Pimpri,Pune 18.
Pune
MAHARASHTRA
411018
India |
| Phone |
8888844203 |
| Fax |
|
| Email |
tvpatil71@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shridhar Pandya |
| Designation |
R&D- coordinator |
| Affiliation |
Gplife Healthcare Pvt Ltd |
| Address |
708 Infinity tower Near Ayurvedic hospital near railway station,Surat
Surat
GUJARAT
305003
India |
| Phone |
9824917109 |
| Fax |
|
| Email |
gplifehealthcare@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pawan Kumar Singh |
| Designation |
Vice President |
| Affiliation |
BVG Life Sciences Ltd.- BVG Group |
| Address |
Sagar Complex, Old Pune-Mumbai Road,Chinchwad.
Pune
MAHARASHTRA
411034
India |
| Phone |
9409616256 |
| Fax |
|
| Email |
pawan.singh@bvglife.com |
|
|
Source of Monetary or Material Support
|
| Gplife Healthcare Pvt Ltd 708, Infinity tower, Near Ayurvedic hospital, near railway station,
Surat-305003 |
|
|
Primary Sponsor
|
| Name |
Mr Ghanshyam Goti |
| Address |
708, Infinity tower, Near Ayurvedic hospital, near railway station,
Surat-305003
|
| Type of Sponsor |
Other [Director of GP life healthcare Pvt. Ltd.] |
|
|
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 Tushar V Patil |
Pimpri Chinchwad Municipal Corporations YCM Hospital |
Head of Department-Pathology, 1st floor, Room No. 127,YCM Hospital, Sant Tukaram nagar,
Pimpri, Pune 18
Pune
MAHARASHTRA |
8888844203
tvpatil71@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PCMCs PGI YCMH Ethics Committee |
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 |
ACT12 tablets and ACT 13 dry Syrup along with standard treatment |
2 tablets of ACT12 and 20 ml ACT 13 dry syrup TDS along with standard of care for 10 days |
| Comparator Agent |
Standard treatment |
Standard treatment as per
protocol of ICMR for 10 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients admitted with RT-PCR confirmed COVID-19 illness.
Age > 18 & < 65 years of either sex
Mild to Moderately Covid 19 disease (NEWS score ≤ 8)
Signed informed consent must be obtained and documented according to AYUSH GCP, and national/local regulations.
|
|
| ExclusionCriteria |
| Details |
Pregnant women
Breastfeeding women
Requiring ICU admission at the screening
Patients above 65 years of age and below 18 Years
Past History of MI, Epileptic episodes
Any other co-morbidity (uncontrolled diabetes, severe hypertension from subject history) which is at critical stage at the screening
Any other condition by which subject proves unfit from investigator perspective
Not giving consent.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
No. of days for negative PCR confirmatory test from nasopharyngeal swab for COVID 19
Change in clinical symptom presentation in Cough, breathlessness, persistent pain and pressure in the chest, bluish discoloration of lips/ face on 5 point ordinal scale
Serum levels of CRP, IgM, IgG
Clinical status expressed in percentage of subjects reporting each severity rating on a 6-point ordinal scale. |
Screening visit, Day 0, Day 4, Day 7 and Day 10 ie end of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in National Early Warning Score.
Hematological parameters like WBS, HB and platelet count etc.
Requirement of admission to intensive care unit
Reduced hospital duration
Changes in biochemical parameters such as Lipid function test, liver function test, renal function test, electrolyte etc.
Global assessment score for overall improvement by Investigator and subject
Safety and tolerability of the intervention |
Screening visit, Day 0, Day 4, Day 7 and Day 10 ie end of study |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2 |
|
Date of First Enrollment (India)
|
05/07/2020 |
| 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="0"
Months="5"
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)?
|
|
Brief Summary
|
The recent outbreak of coronavirus disease in 2019 (COVID-19) caused by SARS-CoV-2 has raised global health concerns. There are many leads in herbs and phytoconstituents which bear scattered pieces of evidence that can prove those beneficial in the prevention, mitigation, and treatment of corona infection. In the background of a deficit of definite antiviral or vaccine for prevention, it is a need of an hour to compile such evidence and come up with products for working in the management of corona infection. GP Lifehealthcare Pvt.Ltd. has developed and planned clinical trial to validate the safety and efficacy of ACT 12 and 13 in mild to moderate COVID 19 patients. |