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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  
Status 
Not Applicable 
 
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.

 
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