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
|
|
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
|
|
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
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (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. |