| CTRI Number |
CTRI/2020/07/026630 [Registered on: 16/07/2020] Trial Registered Prospectively |
| Last Modified On: |
02/10/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical trial of ACT 12 tablet and ACT 13 dry syrup in Covid 19 patients |
|
Scientific Title of Study
|
Phase II, open label, randomized controlled trial to evaluate safety
and efficacy of ACT 12 tablet and ACT 13 dry syrup as an
immunomodulator in adult Covid 19 positive patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MHC/CTH/20-21/002 Ver. 2.0, Dated 03rd June 2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Patsute Sudhir Dadaram |
| Designation |
Medical Superintendent/ In charge RMO |
| Affiliation |
Naidu Hospital |
| Address |
Naidu Hospital, Infectious Diseases Center, Pune Municipal Corporation
Pune MAHARASHTRA 411044 India |
| Phone |
|
| Fax |
|
| Email |
spatsute@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shridhar Pandya |
| Designation |
R&D coordinator |
| Affiliation |
Gplife Healthcare Pvt Ltd |
| Address |
708, seventh floor,Cabin no. 1, 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 |
Second floor, Cabin No. 1, Sagar Complex, Old Pune-Mumbai Road,Chinchwad, Pune
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 [Self- Director GP life healthcare Pvt. Ltd] |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| Dr K M Gajera |
Krishna Pathology Lab. Surat. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr VGVaidya |
Lokmanya Hospital |
Second floor, Infectious disease division, 314/B Telco Road, Chinchwad, Pune 33 Pune MAHARASHTRA |
9822057766
vgvaidya001@gmail.com |
| Dr Patsute Sudhir Dadaram |
Naidu Hospital |
Infectious Diseases department, Ground floor, OPD No. 1, Naidu Hospital, Infectious Diseases Centre, Pune Municipal Corporation Pune MAHARASHTRA |
9409616256
spatsute@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Lokmanya Medical Research Center |
Approved |
| Royal Pune Independent 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 |
ACT 12 tablet and ACT 13 dry syrup |
2 tablets of ACT12 and 20 ml ACT 13 dry syrup thrice a day 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 more than 18 & less than 65 years of either sex
Mild to Moderately Covid 19 disease (NEWS score less than or equal to 8)
Signed informed consent must be obtained and documented according to national/local regulations |
|
| ExclusionCriteria |
| Details |
Pregnant women
Breastfeeding women
Requiring ICU admission at 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 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:None (1), mild (2), moderate (3), severe (4), extremely severe (5)
Serum levels of CRP, IgM, IgG.
Clinical status expressed in percentage of subjects on 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)
|
22/07/2020 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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)
|
In the present study, Gplife Healthcare Private Limited’s
ACT-12 and ACT-13, nutraceutical formulations developed using advanced
phytochemistry, were compared for its safety and clinical efficacy along with
standard of care in Hospitalized COVID 19 patients. The interpretation of the
study parameters obtained is expressed as follows. 60.0% of cases from Test Group i.e. ACT-12 and
ACT-13 along with standard of care showed PCR Negativity at Day 4 compared
to 40% from the standard of care group. 76.66% of cases from Test Group i.e. ACT-12 and
ACT-13 along with standard of care showed PCR Negativity at day 7 compared
to 60% from the standard of care group. No Patient continued to remain positive after the 10th day
in the Test Group i.e. ACT-12 and ACT-13 along with standard of care, whereas
in the standard care group 7 patients (23.3 %) were positive after 10 days. Test group i.e. ACT-12 and ACT-13 along with standard of
care showed substantial improvement in SpO2. The average respiratory rate showed improvement after
addition of ACT-12 and ACT-13 in standard of care and also subjects in same
group were relieved of cough, shortness of breath, fever and Body ache, faster
than subjects on only standard of care. It can be inferred that ACT-12 and
ACT-13 contributed to improve disease-specific symptoms and overall quality of
life of subject. ACT-12 and ACT-13 demonstrated anti-inflammatory activity by
lowering CRP and LDH levels thereby reducing risk of lung tissue injury &
lung fibrosis. Thrombocytopenia is associated with increased risk of severe
disease and mortality in patients with COVID-19; it was found that there was
improvement in Thrombocytopenia in group where ACT-12 and ACT-13 was added in
standard of care which can reduce risk of hospitalization. The IgG and IgM immunoglobulin levels were raised in
subjects treated with ACT-12 and ACT-13 along with standard of care which can
be related to improved antibody functionality and thereby the immunomodulatory
activity offered. In subjects treated with ACT-12 and ACT-13 along with
standard of care, it was found improvement in fluctuated hematological
parameters. No significant post treatment change in any of the biochemical
investigations like liver function, kidney function, and lipid profiles. No
fluctuation found in respiratory rate and blood pressure. This indicates safety
of the ACT-12 and ACT-13 in management of COVID 19. No mortality has been observed in the TEST group (ACT-12 and
ACT-13 along with standard of care) throughout the study and hence this
demonstrates safety of the treatment. No Patient was positive after the 10th
day in the same group. There is consensus that in severe COVID-19 infections, an
exacerbated pulmonary and systemic inflammatory response occurs, with increased
serum levels of inflammatory markers such as C-reactive protein (CRP) and
lactic dehydrogenase (LDH), all of which may result in cytokine storms similar
to SARS and MERS. In present clinical study there is reduction in parameters
like CRP and LDH with quick recovery time which may lead to better management
of the cytokine storm due to ACT-12 and ACT-13 addition in standard of care.
Around 13.3 % CORONA positive cases
in group of ACT-12 and ACT-13 along with standard of care reported with
diabetes and hypertension completely recovered without any other complications. |