Effect of a Combination of Treatment of Reginmune Capsule and Immunofree Tablets in the Treatment of Mild to Moderate COVID-19 Patients
Condition: Treatment of Covid-19 Virus Infection
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      While novel drug discovery and vaccine studies are time taking process, re-purposing old
      drugs against the COVID-2019 epidemic can help identify treatments, with known pre-clinical,
      pharmacokinetic, pharmacodynamic, and toxicity profiles, which can rapidly enter Phase 3 or 4
      or can be used directly in clinical settings. Immunofree has many of the herbs which have
      been evaluated by other trials published for Covid-19 treatment.

      The Immunofree tablet of the test product is an Ayurvedic proprietary medicine and is a
      combination of polyherbal mixture. The components of this formulation are known for their
      anti-viral and immunomodulatory effects. Also, Reginmune, owing to its immunomodulatory
      effect might help in easing the symptoms and decrease the viral load.
    

Detailed description: 
      The symptoms of COVID-19 are mainly for respiratory disorders and similar to severe acute
      respiratory symptoms. The common signs of infection observed in COVID-19 patients include
      respiratory symptoms, sneezing, fever, cough, shortness of breath and other breathing
      difficulties. In case of severely infected patients, infection can cause pneumonia, severe
      acute respiratory syndrome (SARS), kidney failure and even death in many cases. There are
      many people who had high viral load but do not develop COVID-19 symptoms like coughing or
      sneezing. Such asymptomatic people serve as hidden carriers of virus and may further
      contribute in enhanced transmission of virus to other people. In absence of any emergency
      medicine or complete therapy for COVID-19; the prevention of spread of SARS-CoV2 virus and
      regulation of infection is the prime step in controlling this epidemic disease, in which the
      test products can be of immense value.

      The test product, Capsule Reginmune is a combination of some phytochemicals, amino acids,
      vitamins and minerals and a bio-polymer in cellular matrix. The components and their
      pharmacological activities are as follow:

      Echinacea is one of the more popular herbal supplements suggested for boosting immunity. Some
      respiratory and antiviral research has also been done on Echinacea. Echinacea is not
      mentioned by the Indian and Chinese Governments however in their guidelines for boosting
      immunity.

      Cats Claw (Uncaria Tomentosa)has shown potent anti-viral and immunomodulatory activity in a
      recent study. The results demonstrated an in vitro inhibitory activity by both extract and
      alkaloidal fraction, reducing DENV-Ag+ cell rates in treated monocytes. A multiple microbead
      immunoassay was applied for cytokine determination (TNF-alpha, IFN-alpha, IL-6 and IL-10) in
      infected monocyte culture supernatants. The alkaloidal fraction induced a strong
      immunomodulation: TNF-alpha and IFN-alpha levels were significantly decreased and there was a
      tendency towards IL-10 modulation. The researchers conclude that the alkaloidal fraction was
      the most effective in reducing monocyte infection rates and cytokine levels. The antiviral
      and immunomodulating in vitro effects from U. tomentosa pentacyclic oxindole alkaloids
      displayed novel properties regarding therapeutic procedures in Dengue Fever and might be
      further investigated as a promising candidate for clinical application.

      Vitamin C: Well accepted to increase immunity and an effective antiviral. However, not many
      people realize the vast difference in food derived vitamin C and ascorbic acid which is a
      dead synthesized molecule used to clean pools. Therefore, it is strongly recommended that one
      should only take food derived Vitamin C.

      Zinc: There is some evidence suggesting Zinc can shorten duration of the common cold and one
      study done in 2010 showing that Zinc had an effect on the older versions of Corona virus. An
      abundance of evidence has accumulated over the past 50 years to demonstrate the antiviral
      activity of zinc against a variety of viruses, and via numerous mechanisms. Clinical trial
      data support the value of zinc in reducing the duration and severity of symptoms of the
      common cold when administered within 24 hours of the onset of common cold symptoms. However,
      one must be careful as not all zinc is equally bioavailable and more than 150 mg of Zinc can
      lead to toxicity.

      Copper: A study suggested that copper deficiency may lead to reduction in the number of T
      cell lymphocytes and impaired host defense against infectious organisms.

      L- Lysine: Studies shows L-Lysine supplements may help to boost immunity against certain
      viral infections.

      Aloe Vera: Numerous studies for influenza and herpes has shown that Aloe polysaccharides
      (APS) extracted from Aloe vera leaves have evident effects on the therapy of virus infection.

      Lglutamine: Glutamine is the most abundant and versatile amino acid in the body. Glutamine is
      currently part of clinical nutritional supplementation protocols and/or recommended for
      immune suppressed individuals.

      L Arginine: Studies have shown that arginine suppressed the growth of HSV-1, concentration
      dependently and it can boost the activity of T-cells.

      L Isoleucine : It has shown to be effective against rotavirus infection. Magnesium Gluconate:
      It has shown some immunomodulatory effects which was measured by Natural Killer cells
      activities and phagocytosis.

      Sodium Hyaluronate: Hyaluronic acid (HA), one of the main components of extra-cellular matrix
      and most notably of the fundamental substance of conjunctive tissues, is not an inert
      structure. Conversely, it displays important biological properties and plays a significant
      role in crucial physiological processes especially when cellular plasticity is involved such
      as inflammation, immune reactions, angiogenesis and would healing. It is also strongly
      involved in neoplastic cells migration and therefore in metastatic spreading of malignant
      tumors.

      The Immunofree tablet of the test product is an Ayurvedic proprietary medicine and is a
      combination of polyherbal mixture. The components of this formulation are known for their
      anti-viral and immunomodulatory effects.

      Kalmegh also known as Andrographis paniculata has been used in Ayurveda and other herbal
      traditions for boosting up the immune system. It is believed that the herb has potential
      antiviral and immunomodulatory properties owing to it containing andrographolide. The
      following studies are done on it which suggest potential benefit.

      Bhumyamalaki: It is also known as Phyllanthus niruri. It seems to exhibit anti-viral
      anti-inflammatory activity. The following studies for SARS suggest that this may be of
      benefit.

      Glycyrrhiza glabra is also known as licorice, mulethi, etc. It has been used in TCM, Ayurveda
      and other herbal traditions for lung health and stomach health. It is very alkalizing. It is
      believed that it has strong antiviral properties and hence this herb is in both Chinese and
      Indian recommendations. This herb contains glycyrrhizin which showed remarkable qualities in
      SARS research.

      Some reports suggest that strong extracts of this herb are central to the Chinese strategy in
      Wuhan. The following studies are done on it, which suggest potential benefit.

      Tulsi is also known as Ocimum sanctum has been used traditionally in India. It is considered
      a sacred herb in Ayurveda.Following studies are done on it which suggest potential benefit.

      Giloy is also known as Tinospora cordifolia has been used traditionally in Ayurveda as it
      helps in boosting gut immunity.

      Pushkarmool: It is also known as Inula racemosa and it may be an effective herb for flu
      symptoms. It also supports the normal functioning of the respiratory system.

      The drug Pushkarmool has been used in the indigenous system of medicine for a long time.
      Pushkarmool has been reported in the texts of Ayurveda as possessing Tikta, Katu and Ushna
      Virya and beneficial for the diseases of heart, throat. It is known to act as an expectorant.
      It is also used in Ayurveda as an expectorant and resolvent in indurations. Its
      pharmacological activities include cardioprotective activity, antiallergic activity,
      antimutagenic and antiapoptotic effects, anti-inflammatory & analgesic effect, adrenergic
      beta blocking activity.

      Alpinia galanga is also known as rasna, sugandhimool, etc. It has been used inTCM, Ayurveda
      and other herbal traditions for lung health and the potential to reduce the inflammatory
      process. It is believed that the herb has antiviral activity in human respiratory syncytial
      viruses. The following studies are done on it which suggest potential benefit.

      Draksha: It is also known as Vitis Vinifera. Studies suggeset that the herb possesses a broad
      spectrum of pharmacological and therapeutic effects such as antioxidative, anti-inflammatory,
      and antimicrobial activities.

      Haldi is also known as Turmeric, Curcuma longa, etc. Alkaloids derived from turmeric have
      shown potentially strong inhibitory effects on the neuraminidases from two influenza viral
      strains. The following studies are done on it which suggest potential benefit.

      Haritaki is also known as Terminalia chebula has been used in TCM, Ayurveda, and other herbal
      traditions for boosting immunity. The herb is also possibly useful for easing the symptoms
      associated with respiratory illnesses. The following studies are done on it which suggest
      potential benefit.

      Aloe Vera: Studies show that extracts of Aloe Vera may help to inhibit the activity of the
      virus and support the functioning of the lungs.

      Shilajit: It is also known as Asphaltum: It has been used traditionally by the Indian
      Ayurvedic and Siddha systems of traditional medicine to enhance the quality of life. Studies
      show that the minerals in Shilajit may also possesses immune boosting activities.

      Pippali: It is also known as Piper longum. It has been used traditionally in the Ayurvedic
      system for lung health. Studies suggest that it may help to improve lung function.

      Shaival: It is also known as Asthaxantin. Studies show that it may possess antimicrobial and
      anti-inflammatory properties.

      Damanaka - Also known as Artemisia, has potential anti-malarial properties.
    

Intervention name(s): Immunofree tablets and Reginmune capsule
Intervention type(s): Combination Product
Intervention description(s): 2 Immunofree tablets thrice a day at an interval of 4-5 hours for 10 days and 1 Reginmune capsule twice a day for 10 days
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: After obtaining the informed consent, patients will be screened by undergoing various assessments and after confirming eligibility, eligible patients will be randomized in the study and assigned either to the test group or control group with Best standard of care as per institutional practice, for 10 days treatment period. Patient will be hospitalized during the treatment period.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: coronavirus; covid-19; covid; corona; coagulation; immunofree; mgcts; biogetica