FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/09/036100 [Registered on: 01/09/2021] Trial Registered Prospectively
Last Modified On: 31/08/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   controlled trial of SHIRO KLOMAN treatment in mild to moderate symptomatic patients with SARS-CoV-2 Infection (Covid-19). 
Scientific Title of Study   A multi-centre, randomized, open label, two arm, controlled trial of SHIRO KLOMAN given along with treatment of physician’s choice versus treatment of Conventional Covid Protocol in mild to moderate symptomatic patients with SARS-CoV-2 Infection (Covid-19). 
Trial Acronym  SHIRO KLOMAN 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Tapan Shah 
Designation  Principal Investigator 
Affiliation  Sanad Janta Multispeciality Hospital.  
Address  Sanad Janta Multispeciality Hospital. Ahmedabad
Sanand
Ahmadabad
GUJARAT
382110
India 
Phone  09825739241  
Fax    
Email  drtapansah@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Tapan Shah 
Designation  Principal Investigator 
Affiliation  Sanad Janta Multispeciality Hospital.  
Address  Sanad Janta Multispeciality Hospital. Ahmedabad
Sanand
Ahmadabad
GUJARAT
382110
India 
Phone  09825739241  
Fax    
Email  drtapansah@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Tapan Shah 
Designation  Principal Investigator 
Affiliation  Sanad Janta Multispeciality Hospital.  
Address  Sanad Janta Multispeciality Hospital. Ahmedabad
Sanand
Ahmadabad
GUJARAT
382110
India 
Phone  09825739241  
Fax    
Email  drtapansah@gmail.com  
 
Source of Monetary or Material Support  
Bindi Prashant Shah C/o Shiroratna Ayurveda LLP Plot 12&13, Opp Gokuldham, Sanand  
 
Primary Sponsor  
Name  Bindi Prashant Shah 
Address  Shiroratna Ayurveda LLP Ahmedabad 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Tapan Shah  Sanand Janta Multispeciality Hospital  Sanand Bawla Road, Sanand
Ahmadabad
GUJARAT 
9825739241

drtapansah@gmail.com 
Neeraj Mehta  Shri Panchnath Sarvajanik Trust  Mangalaben Dayabhai Kotecha Hospital
Rajkot
GUJARAT 
9998854392

drnirajdm@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Giriraj Hospital Research Ethic COmmitte  Submittted/Under Review 
sangini hospital Ethic committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J101||Influenza due to other identifiedinfluenza virus with other respiratory manifestations. Ayurveda Condition: COVID-19, (2) ICD-10 Condition:B972||Coronavirus as the cause of diseases classified elsewhere. Ayurveda Condition: Covid 19,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Composition:- Lavang ext. Syzgiumaromaticum (A.P.I)* 350 mg Jethimadh ext. Glycyrrhizaglabra (A.P.I)* 2050 mg Nimbu ext. Citrus limon (A.P.I)* 475 mg Santra ext. Citrus reticulate (Bh.P.)* 675 mg Mahuda ext. Bassia latifolia (Bh.P.)* 4600 mg, Reference: Jethimadh ext. Glycyrrhizaglabra , Route: Oral, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 1(ml), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 3 Days, anupAna/sahapAna: No, Additional Information: 1 ml per dose 3 times a day
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Have positive reverse-transcriptase-polymerase chain reaction (RT-PCR) test for COVID-19 in a diagnostic specimen.
Are either asymptomatic or have only mild symptoms (cough and/or fever and/or sore throat and/or other upper respiratory symptoms and/or malaise, headache, muscle pain) at the time of study inclusion.
Have an oxygen saturation of >94% while breathing ambient air, if this is measured.
Have either normal levels of haematological, liver and renal functions, and electrolytes OR no worse than Grade 1 (CTCAE Version 5.0) abnormalities in any of these parameters. High blood sugar or HbA1c of any degree will not be a criterion for exclusion.

Sexually active women, unless surgically sterile (at least 6 months prior to study drug administration) or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy [including oral, transdermal, or implanted contraceptives (any hormonal method in conjunction with a secondary method), intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile (at least 6 months prior to study drug administration) sexual partner] during study and up to 30 days after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician.
 
 
ExclusionCriteria 
Details  Have pneumonia confirmed by chest imaging.
Patients receiving mechanical ventilation or ECMO or who have multiorgan failure.
Pregnant or lactating females.
Therapy with an investigational agent within the past 30 days from screening.
Treatment with any agent with anti-SARS-CoV-2 activity prior to screening.
Any other conditions, including moderate to severe illness, which would make the patient, in the opinion of the Investigator, unsuitable for the study.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the efficacy of SHIRO KLOMAN in the management of mild to moderate COVID-19 cases  Screening,Baseline,3rd Day, 8th day 15th day 
 
Secondary Outcome  
Outcome  TimePoints 
1. Percentage of patients with negative SARS-CoV-2 on nasal or throat swab   Screening, Baseline, 3rd Day 8th day 15th day 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   10/09/2021 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The novel corona virus Covid-19 has caused a massive pandemic with large number of fatalities in many countries and is shortly expected to reach the devastating levels of the 1918 influenza pandemic (1). No proven effective treatments have yet been discovered to treat the viral pneumonia caused by Covid-19, although a few drugs have shown some promise. Covid-19 is caused by SARS-CoV-2 virus which is an enveloped positive sense RNA virus with an unusually large RNA genome. Other drugs active against SARS-CoV-2 are actively studied, such as protease inhibitors. But drugs with distinct and varied mechanisms of action are needed to propose efficient drug combinations. Here we propose an innovative approach based on the use of the saponin drug glycyrrhizin, which we believe can be useful to combat the virus infection and to treat the associated respiratory symptoms. We searched for a drug that could not only inhibit viral replication but also interfere with the entry of the virus into cells. On the one hand, we reasoned that an amphiphilic compound like a saponin could interfere with the virus entry into cells, owing to the well-known membrane effects of this class of compounds. On the other hand, we considered that a target associated to “danger-signals” in cells, like HMGB1, could be a useful to trigger an immune response. At present, there are no specific antiviral drugs or vaccine against COVID-19 infection for potential therapy of humans. In desperate times like today’s, it will be worthwhile testing – SHIRO KLOMAN as supplimentary treatment for the corona virus infected patients.

SHIRO KLOMAN can be easily combined with many types of drugs, either to promote solubilization and bioavailability of the co-transported product as discussed above, or to complement its mechanism of action leading to synergistic effects in some cases.

 
Close