controlled trial of SHIRO KLOMAN treatment in mild to moderate symptomatic patients with SARS-CoV-2 Infection (Covid-19).
- Conditions
- 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,
- Registration Number
- CTRI/2021/09/036100
- Lead Sponsor
- Bindi Prashant Shah
- Brief Summary
The novel coronavirus Covid-19 has caused a massive pandemic with large number of fatalities inmany countries and is shortly expected to reach the devastating levels of the1918 influenza pandemic (1). No proven effective treatments have yet beendiscovered to treat the viral pneumonia caused by Covid-19, although a fewdrugs have shown some promise. Covid-19 is caused by SARS-CoV-2 virus which isan 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 ofaction are needed to propose efficient drug combinations. Here we propose aninnovative approach based on the use of the saponin drug glycyrrhizin, which webelieve can be useful to combat the virus infection and to treat the associatedrespiratory symptoms. We searched for a drug that could not only inhibit viralreplication but also interfere with the entry of the virus into cells. On theone hand, we reasoned that an amphiphilic compound like a saponin couldinterfere with the virus entry into cells, owing to the well-known membraneeffects of this class of compounds. On the other hand, we considered that atarget associated to “danger-signals†in cells, like HMGB1, could be a usefulto trigger an immune response. At present, there are no specific antiviral drugs orvaccine against COVID-19 infection for potential therapy of humans. Indesperate times like today’s, it will be worthwhile testing – SHIRO KLOMAN assupplimentary treatment for the corona virus infected patients.
SHIRO KLOMAN can be easily combined with manytypes of drugs, either to promote solubilization and bioavailability of theco-transported product as discussed above, or to complement its mechanism ofaction leading to synergistic effects in some cases.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 120
- 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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the efficacy of SHIRO KLOMAN in the management of mild to moderate COVID-19 cases Screening,Baseline,3rd Day,8th day15th day
- Secondary Outcome Measures
Name Time Method 1.Percentage of patients with negative SARS-CoV-2 on nasal or throat swab Screening,Baseline,3rd Day8th day15th day
Trial Locations
- Locations (2)
Sanand Janta Multispeciality Hospital
🇮🇳Ahmadabad, GUJARAT, India
Shri Panchnath Sarvajanik Trust
🇮🇳Rajkot, GUJARAT, India
Sanand Janta Multispeciality Hospital🇮🇳Ahmadabad, GUJARAT, IndiaDr Tapan ShahPrincipal investigator9825739241drtapansah@gmail.com