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
|
|
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
|
|
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 |