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CTRI Number  CTRI/2022/02/040687 [Registered on: 28/02/2022] Trial Registered Prospectively
Last Modified On: 16/05/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To Assess the Safety and Efficacy of Imusil tablet in Treatment of Adult Subjects with mild COVID-19 
Scientific Title of Study   A Prospective, Randomized, Multi-center, Open-label, Interventional Study to Evaluate the Safety and Efficacy of Imusil (Kutki Extract 200 mg plus Guduchi extract 60 mg plus Amla extract 60 mg) tablet in Treatment of Adult Subjects with mild COVID-19 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
IMU/GLPL/PHASE IV/2022,V 1.0 / 02 Feb 2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Antaryami Maharana 
Designation  General manager Medical affairs and Pharmacovigilance  
Affiliation  Abiogenesis clinpharm private Limited  
Address  2nd Floor, Plot No 69, D No. 8-2-248_1_7_69, Nagarjuna Hills,Punjagutta, Hyderabad Telangana, India Hyderabad
Department of medical affairs and Pharmacovigilance
Hyderabad
TELANGANA
500082
India 
Phone    
Fax    
Email  antaryami@abiogenesisclinpharm.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mahesh Abhyankar 
Designation  Director – Strategy and Business growth  
Affiliation  GLOWDERMA LAB PVT LTD  
Address  303, A-Wing, Naman Midtown, Senapati Bapat Marg, Prabhadevi (West), Mumbai, Mumbai (Suburban)
Department of Strategy And Business Growth
Mumbai (Suburban)
MAHARASHTRA
400013
India 
Phone  9820450986  
Fax    
Email  drmahesh.abhyankar@glowderma.com  
 
Details of Contact Person
Public Query  
Name  Mr Rajendra Mehta 
Designation  Director - Marketing & Sales 
Affiliation  glowderma lab private limited  
Address  303, A-Wing, Naman Midtown, Senapati Bapat Marg, Prabhadevi (West), Mumbai
marketing & sales
Mumbai (Suburban)
MAHARASHTRA
400013
India 
Phone  9769787850  
Fax    
Email  rajendra.mehta@glowderma.com  
 
Source of Monetary or Material Support  
Glowderma Lab Private Limited,303, A-Wing, Naman Midtown, Senapati Bapat Marg, Prabhadevi (West), Mumbai – 400013  
 
Primary Sponsor  
Name  Glowderma Lab Private Limited 
Address  303, A-Wing, Naman Midtown, Senapati Bapat Marg, Prabhadevi (West), Mumbai – 400013  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr B Nagaraju  Aster Prime Hospitals  Opp. Passport,Hyderabad-500038, Telangana state, India
Hyderabad
TELANGANA 		 9848883444

nagaraj.boyilla@gmail.com 
Dr Mohammed Zaki Siddique   MLB Medical College  Covid Hospital, PMSSY Block,Jhansi (UP) 284128, India
Jhansi
UTTAR PRADESH 		 9450137367

drzakimlb@gmail.com 
Dr P Raghavendra Reddy  Renova Neelima Hospitals  Opp.Voltas compnay,Sanathnagar, Hyderabad-500018, Telangana state,India.
Hyderabad
TELANGANA 		 7799992266

drraghavendrareddy.p@gmail.com 
Dr Varun A Bafna  Star Superspeciality Hospital  Dileep Kulkarni Hear hospial,Kolhapur-416005,MAhrastra
Kolhapur
MAHARASHTRA 		 9066565353

research.dr12@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Ethics committee- MLB medical college  Approved 
Ethics committee-Prime Hospitals  Submittted/Under Review 
Institutional committee-Neelima Hospitals  Approved 
institutional Ethics committee, Care Multispeciality Hospital  Approved 
Om Sai Onco Instition Etchics committee  Submittted/Under Review 
 
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. Ayurveda Condition: covid-19, (2) ICD-10 Condition:J99||Respiratory disorders in diseasesclassified elsewhere. Ayurveda Condition: covid-19,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-STANDARD OF CARE Standard of Care for Covid 19 as per health and family welfare ministry, india guidelines
2Intervention ArmDrugClassical(1) Medicine Name: imusil, Reference: standard of Care for covid 19, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 200(mg), Frequency: qid, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: water), Additional Information: Kutki Extract 200 mg plus Guduchi extract 60 mg plus Amla extract 60 mg
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Male or female subjects of ≥18 to 60 years of age both inclusive
2.Subjects willing to give informed consent and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
3.Confirmed case of COVID-19 infection by RT-PCR and mild (without any non-invasive ventilation or high flow oxygen or assisted ventilation) cases of COVID-19. Scores of 2-3 on the WHO Eight point Ordinal Scale
4.Time interval between symptoms onset and randomization of no more than 2 days
5.One or more of the following symptoms:
Fever of ≥100.4°F
Cough
Sore throat
Headache
Nasal congestion
Malaise
Diarrhea
Loss of smell
Loss of taste
6.Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 30 days after the last dose of assigned treatment. A subject is of child-bearing potential if, in the opinion of the Investigator, he/she is biologically capable of having children and is sexually active.
 
 
ExclusionCriteria 
Details  1.Subjects with a history of severe infections (pneumonia, septicemia, etc.), severe cardiac or pulmonary diseases, or received immunosuppressive therapy or other investigational drugs within the previous 30 days of screening
2.Known or suspected hypersensitivity to any herbal medication containing extracts of Kutki or Guduchi, or Amla
3.Women of child bearing potential who are currently pregnant, lactating or who are not willing to use contraception during the entire duration of the study
4.Men who are unwilling to use contraception while receiving investigational product
5.Subjects with a history of any severe disease which is expected to prevent compliance with the present protocol
6.Subjects with respiratory rate >24/min or with SPO2 ≤93%
7.Subjects with a history of severe renal and hepatic impairment. (creatine ≥2 mg/dl; liver enzymes and bilirubin 2.5 times ULN; alkaline phosphatase 1.5 times ULN)
8.Recent treatment with any herbal immunomodulator in the past 7 days
9.Known history of failure to control systemic fungal, bacterial or viral infection
10.Subjects with a history of the following co-morbidities: uncontrolled diabetes, uncontrolled hypertension with or without cardiac symptoms, morbid obesity with diabetes and/or hypertension or any other metabolic syndrome
11.Subjects with known human immunodeficiency virus (HIV) or hepatitis B or C classes of active viral infection
12.Have a history of neurological or psychiatric disorders, including epilepsy or dementia
13.Subjects for whom ventilator support is required at screening
14.Subjects not willing to give their informed consent to participate in the clinical trial
15.According to the Investigators judgment, there are concomitant diseases with a serious safety hazard or affect the subject
16.Using other experimental drugs or participating in other clinical trials in the prior one month.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Rate of SARS-CoV2 RT-PCR negativity and changes in CT value in nasopharyngeal and/or oropharyngeal swab at Day 4plus1 and Day 8plus2
Proportion of subjects with a 2-point decrease in ordinal scale (as recommended by WHO) at Day 4plus1 and Day 8plus2
Changes in blood inflammatory indexes for CRP, Interleukin IL-6, and D-Dimer at Day4plus1 and Day 8plus2. 		 Day 4 and Day 8  
 
Secondary Outcome  
Outcome  TimePoints 
Adverse events (AEs) during the study
Serious adverse events (SAEs) during the study
 		 day 1 to EOS 
 
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 4 
Date of First Enrollment (India)   01/03/2022 
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="6"
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   A Prospective, Randomized, Multi-center, Open-label, Interventional Study to Evaluate the Safety and Efficacy of Imusil® (Kutki Extract 200 mg + Guduchi extract 60 mg + Amla extract 60 mg) tablet in Treatment of Adult Subjects with mild COVID-19

Primary Efficacy Outcome:
•Rate of SARS-CoV2 RT-PCR negativity and changes in CT value in nasopharyngeal and/or oropharyngeal swab at Day 4plus1 and Day 8plus2
•Proportion of subjects with a 2-point decrease in ordinal scale (as recommended by WHO) at Day 4plus1 and Day 8plus2
•Changes in blood inflammatory indexes for CRP, Interleukin IL-6, and D-Dimer at Day4plus1 and Day 8plus2. 

Secondary Safety Outcomes:
•Adverse events (AEs) during the study
•Serious adverse events (SAEs) during the study.
 
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