FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/08/027224 [Registered on: 18/08/2020] Trial Registered Prospectively
Last Modified On: 13/04/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To observe the effect of Ayurvedic medicine (Ashwagandha and Shunti) for the treatment of COVID-19 
Scientific Title of Study   A Prospective Randomized Controlled Clinical Trial to evaluate the Efficacy and Safety of Ayurveda Interventions (Ashwagandha Tablet and Shunti Capsule) in the management of COVID-19 infection (Mild to Moderate symptoms) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Harbans Singh 
Designation  Research Officer (Ay.), Scientist-2 
Affiliation  Central Ayurveda Research Institute for Respiratory Disorders 
Address  Moti Bagh Road
Room No: 217, Department of Clinical Research
Patiala
PUNJAB
147001
India 
Phone  9501248820  
Fax  0175-2223663  
Email  dr.harbans@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sumit Shrivastva 
Designation  Dean Academic Professor and HOD, Department of Roganidana 
Affiliation  Shri Dhanwantry Ayurvedic College and Hospital 
Address  77, Chandi Path, Sector 46B,
Room No. 116, Ground floor, Shri Dhanwantry Ayurvedic Hospital
Chandigarh
CHANDIGARH
160047
India 
Phone  9781110780  
Fax    
Email  sumitpankaj@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sumit Shrivastva 
Designation  Dean Academic Professor and HOD, Department of Roganidana 
Affiliation  Shri Dhanwantry Ayurvedic College and Hospital 
Address  77, Chandi Path, Sector 46B,
Room No. 116, Ground floor, Shri Dhanwantry Ayurvedic Hospital
Chandigarh
CHANDIGARH
160047
India 
Phone  9781110780  
Fax    
Email  sumitpankaj@gmail.com  
 
Source of Monetary or Material Support  
Central Council for Research in Ayurvedic Sciences, New Delhi 
 
Primary Sponsor  
Name  Central Council for Research in Ayurvedic Sciences New Delhi 
Address  Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan 61-65, Institutional Area, Opposite D-Block,Janakpuri, New Delhi-110058 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sumit Shrivastva  Shri Dhanwantry Ayurvedic College and Hospital  Room No. 116, Ground floor, 77 Chandi Path, Sector 46B
Chandigarh
CHANDIGARH 
9781110780

sumitpankaj@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee Central Ayurveda Research Institute for Respiratory Disorders Moti Bagh Road Patiala Punjab 147001  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ashwagandha tablet and Shunti capsule  a. Ashwagandha Tablet Dose: 2 Tablets 250mg each( twice daily) Dosage form: Tablets Route of Administration:Oral Time of Administration: Twice a day 2 hrs after food Anupana:Water Duration of therapy: 15 days b. Shunti Capsule Dose: 2 capsules 500 mg each (twice daily 2-0-2) Dosage form: Capsule Route of Administration:Oral Time of Administration: Twice a day atleast 30 minutes after food Anupana: Water Duration of therapy:15 days  
Comparator Agent  Conventional standard therapy for COVID-19 positive patients  Conventional standard therapy as per ICMR guidelines 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Mild to moderate cases registered in the Hospital, with COVID 2019 (Confirmed by Antigen test/ RT-PCR) quarantined at identified hospital set up.
2. Participants who can take medicines orally
3. Patients with either sex, 18 to 75 years age
4. Patients willing to provide signed informed consent
 
 
ExclusionCriteria 
Details  1. Cases of severe vomiting which would make oral administration of medicine difficult.
2. Patients with hyperacidity and gastric ulcer to be excluded.
3. 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.
5. 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.
8. Any other condition, which as per the investigator would jeopardize the outcome of the trial.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
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).
3. No of cases reporting any ADR/AE.
4. Number of patients referred due to progressing/worsening of disease.
5. Number of cases that required invasive or non-invasive oxygen therapy during the intervention.
 
On 7th day and 15th day 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "48"
Final Enrollment numbers achieved (India)="48" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   25/08/2020 
Date of Study Completion (India) 21/02/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
under publication 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

COVID-19 has emerged as the latest pandemic that erupted in the Wuhan City of People’s Republic of China in December 2019, which is affecting human health and economy across the world. 8,242,999 cases have been reported globally as on June 19, 2020, according to the WHO Dash board with total deaths at 445,535. The occurrence of the ongoing COVID-19 in developed countries also highlights the fact that developed countries and rich populations are not immune to the outbreaks of infectious diseases.

India currently has around 16,32,48 cases with the death toll at 12753 as on 19 June 2020. In Maharashtra, the death toll is significantly higher than other states that have a high number of cases, such as Tamil Nadu and Delhi.The first case of the 2019–20 coronavirus pandemic in the Indian state of Maharashtra was confirmed 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 of approved effective drug therapeutic protocols for CoVs would be a challenge for the treatment of the newly emerged COVID-19 infections worldwide.

In general, after a virus invades the host, it is first recognized by the host innate immune system through pattern recognition receptors (PRRs) including C-type lectin-like receptors, Toll-like receptor (TLR), NOD-like receptor (NLR), and RIG-I-like receptor (RLR). Through different pathways, the virus induces the expression of inflammatory factors, maturation of dendritic cells, and synthesis of type I interferons (IFNs) which limit the spreading of the virus and accelerate macrophage phagocytosis of viral antigens.  T lymphocytes including CD4+ and CD8+ T cells play an important role in the defense. CD4+ T cells stimulate B cells to produce virus-specific antibodies, and CD8+ T cells directly kill virus-infected cells. T helper cells produce pro-inflammatory cytokines to help the defending cells.The humoral immunity including complements such as C3a and C5a and antibodies is also essential in combating the viral infection.

Drug repurposing, which is defined as identifying alternative uses for approved or investigational drugs outside their defined indication, could be a possible way to overcome the time limitation of research and development needed to design a therapeutic drug to combat the pathogen. The drug repurposing or repositioning approach thus can facilitate prompt clinical decisions at lower costs than de novo drug development. Though drug repurposing is sometimes based on chance observations, target-based repurposing of drugs depends on prior understanding of the precise molecular or cellular element that is recognized by the proposed drug.

Ayurveda and traditional systems of Medicine in India have been treating diseases of infectious and non-infectious origin equally with expansive success rates, treating the patients through an individualized person-to-person approach depending 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 of conventional Traditional medicine for many ailments. It is described in classics 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 at least in part to the reported antistress, immunomodulatory, cognition facilitating, antiinflammatory and antiageing properties (Bhattacharya et al., 1997b).

It has been used as an adaptogen or to build resistance to stress or diseases in indigenous medical systems in India for centuries. Modern scientific data indicate several bioactive molecules (withanolides, withanosides, indosides, withaferin-A, others) with significant immunomodulatory, anti-inflammatory and stress reducing properties. The selective Th1 up-regulation by aqueous extract of Ashwagandha roots has been shown in a mice model.  Administration of W. somnifera was found to increase total WBC and bone marrow cells significantly indicating that the extract could stimulate the haemopoetic system. Moreover there was increased presence of a-esterase positive bone marrow cells indicating that Withania treatment could also enhance the differentiation of stem cells. In the same study, it was also observed that W. somnifera extract was found to increase the circulating antibody titre and antibody forming cells and immunological activity was found to be active several days thereafter.

Shunti (API, Part I, Vol 1 page 137):

Shunti is the dried rhizome of Zingiber officinale Roxb and is used as part of diet and medicine in Indian Tradition. It is having Katu Rasa and Ushna Guna and Vata-Kapha Haraproperties. The rich phytochemistry of ginger includes components that scavenge free radicals produced in biological systems. The anti-oxidative properties of ginger and its components have been explored in various in vitro and in vivo tests. Strengthening the body’s defenses by improving the antioxidant status will undoubtedly protect human against many chronic diseases. Gingerol, shogaol, and other structurally-related substances in ginger inhibit prostaglandin and leukotriene biosynthesis through suppression of 5-lipoxygenase or prostaglandin synthetase. Additionally, they can also inhibit synthesis of pro-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 management of COVID 19 Cases through an RCT 
Close