To observe the effect of Ayurvedic medicine (Ashwagandha and Shunti) for the treatment of COVID-19
- Conditions
- Coronavirus as the cause of diseases classified elsewhere,
- Registration Number
- CTRI/2020/08/027224
- Lead Sponsor
- Central Council for Research in Ayurvedic Sciences New Delhi
- Brief Summary
COVID-19 has emerged as the latest pandemic that erupted in the Wuhan Cityof People’s Republic of China in December 2019, which is affecting humanhealth and economy across the world. 8,242,999 cases have been reported globally as onJune 19, 2020, according to the WHO Dash board with total deaths at 445,535. The occurrenceof the ongoing COVID-19 in developed countries also highlights the fact that developedcountries and rich populations are not immune to the outbreaks of infectiousdiseases.
India currently has around 16,32,48 cases with the death toll at12753 as on 19 June 2020. In Maharashtra, the death toll issignificantly higher than other states that have a high number of cases, suchas Tamil Nadu and Delhi.Thefirst case of the 2019–20coronavirus pandemic in the Indian state of Maharashtra wasconfirmed on 9thMarch 2020.
Coronaviruses (CoVs) belong to the family Coronaviridae and are enveloped, single-stranded,positive-sense RNA viruses.The SARS-CoV-2 belongs to the beta CoV genus which also includes the SARS-CoV-1 and the MERS-CoV. The lack ofapproved effective drug therapeutic protocols for CoVs would be a challenge forthe treatment of the newly emerged COVID-19 infections worldwide.
In general, after a virus invades the host, it is first recognizedby the host innate immune system through pattern recognition receptors (PRRs) including C-type lectin-like receptors,Toll-likereceptor (TLR), NOD-like receptor (NLR), and RIG-I-like receptor (RLR). Through different pathways, the virus induces the expressionof inflammatory factors, maturation of dendritic cells, and synthesis of type Iinterferons (IFNs) which limit the spreading of the virus and accelerate macrophagephagocytosis of viral antigens. T lymphocytes including CD4+ andCD8+ T cells play an important role in the defense. CD4+ Tcells stimulate B cells to produce virus-specific antibodies, and CD8+ Tcells directly kill virus-infected cells. T helper cells produce pro-inflammatory cytokines to help the defending cells.The humoralimmunity including complements such as C3a and C5a and antibodies is alsoessential in combating the viral infection.
Drug repurposing, which is defined as identifying alternative usesfor approved or investigational drugs outside their defined indication, couldbe a possible way to overcome the time limitation of research and developmentneeded to design a therapeutic drug to combat the pathogen. The drug repurposing orrepositioning approach thus can facilitate prompt clinical decisions at lowercosts than de novo drug development. Though drug repurposing is sometimes based onchance observations, target-based repurposing of drugs depends on prior understanding of theprecise molecular or cellular element that is recognized by the proposed drug.
Ayurveda and traditional systems of Medicine in India have beentreating diseases of infectious and non-infectious origin equally with expansive successrates, treating the patients through an individualized person-to-person approachdepending upon the presentation of clinical symptoms in each.
***Ashwagandha* : (API, Part I, Vol 1 page 19)**
Withania somnifera Dunal. (Fam. Solanaceae) has been used as part ofconventional Traditional medicine for many ailments. It is described inclassics as having *Tikta, Kasaya Rasa* and *Ushna guna* and its *Prabhava*is *Rasayana* and *Vajikarana.* The active constituents of plant (Withaferin A,Sitoindosides VII–X) are reported to have an antioxidant activity which may contribute atleast in part to the reported antistress, immunomodulatory, cognitionfacilitating, antiinflammatory and antiageing properties (Bhattacharya et al., 1997b).
It has been used as an adaptogen or to buildresistance to stress or diseases in indigenous medical systems in India forcenturies. Modern scientific data indicate several bioactive molecules(withanolides, withanosides, indosides, withaferin-A, others) with significantimmunomodulatory, anti-inflammatory and stress reducing properties. Theselective Th1 up-regulation by aqueous extract of Ashwagandha roots has beenshown in a mice model. Administration ofW. somnifera was found to increase total WBC and bone marrow cellssignificantly indicating that the extract could stimulate the haemopoeticsystem. Moreover there was increased presence of a-esterase positive bonemarrow cells indicating that Withania treatment could also enhance thedifferentiation of stem cells. In the same study, it was also observed that W.somnifera extract was found to increase the circulating antibody titre andantibody forming cells and immunological activity was found to be activeseveral days thereafter.
***Shunti* (API, Part I, Vol 1 page 137):**
*Shunti* is the dried rhizome of Zingiberofficinale Roxb and is used as part of diet and medicine in Indian Tradition.It is having *Katu Rasa* and *Ushna Guna* and *Vata-Kapha Hara*properties.The rich phytochemistry of ginger includes components that scavenge freeradicals produced in biological systems. The anti-oxidative properties ofginger and its components have been explored in various in vitro and in vivotests. Strengthening the body’s defenses by improving the antioxidant statuswill undoubtedly protect human against many chronic diseases. Gingerol,shogaol, and other structurally-related substances in ginger inhibitprostaglandin and leukotriene biosynthesis through suppression of 5-lipoxygenaseor prostaglandin synthetase. Additionally, they can also inhibit synthesis ofpro-inflammatory cytokines such as IL-1, TNF-α, and IL-8.
In this study, the combined potential of *Ashwagandha*tablet and *Shunti* capsule is to be explored in the clinical managementof COVID 19 Cases through an RCT
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
- Mild to moderate cases registered in the Hospital, with COVID 2019 (Confirmed by Antigen test/ RT-PCR) quarantined at identified hospital set up.
- Participants who can take medicines orally 3.
- Patients with either sex, 18 to 75 years age 4.
- Patients willing to provide signed informed consent.
- Cases of severe vomiting which would make oral administration of medicine difficult.
- Patients with hyperacidity and gastric ulcer to be excluded.
- Chronic, Severe, Unstable, Uncontrolled co-existent medical illness such as Diabetes, Hypertension, Cardiac disorders, kidney disorders and lung disorders or other disease of concern which may put the patient at increased risk during the study 4.
- Cases of respiratory failure and requiring mechanical ventilation.
- Patients with COVID 19 in critical condition or ARDS or NIAD 8 –point ordinal score 2 Hospitalized, on invasive mechanical Ventilation or extra corporeal membrane oxygenation 6.
- Pregnant or lactating women 7.
- Any patient with proved sensitivity to the trial drugs may be excluded.
- Any other condition, which as per the investigator would jeopardize the outcome of the trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Clinical cure rate: Time to negative conversion of severe acute respiratory syndrome corona-virus 2.(From the day of randomization) On 7th day and 15th day
- Secondary Outcome Measures
Name Time Method 1. Duration of fever and each of the respiratory symptoms. 2. Improvement in hematological and laboratory parameters (CBC, LFT, RFT, Lipid profile, FBS, ESR, Hs-CRP, LDH, S. Ferritin, D-dimer, TNF-α, IL-6, Serum IgG for COVID-19, Serum IgM for COVID-19, RT-PCR and HRCT Chest Scan).
Trial Locations
- Locations (1)
Shri Dhanwantry Ayurvedic College and Hospital
🇮🇳Chandigarh, CHANDIGARH, India
Shri Dhanwantry Ayurvedic College and Hospital🇮🇳Chandigarh, CHANDIGARH, IndiaDr Sumit ShrivastvaPrincipal investigator9781110780sumitpankaj@gmail.com