| CTRI Number |
CTRI/2022/09/045632 [Registered on: 19/09/2022] Trial Registered Prospectively |
| Last Modified On: |
15/09/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
To study the clinical effect and molecular mechanisms of herbal formulation in combating Covid-19 |
|
Scientific Title of Study
|
To determine the clinical efficacy, safety and molecular mechanisms of Guduchyadi tablets in combating COVID-19 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IND-AIIA-Guduchyadi-2022-2, Version 2.0, 20 Jun 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Dr Tanuja M Nesari |
| Designation |
Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
All India Institute of Ayurveda Mathura Rd
Gautam Puri
Sarita Vihar
New Delhi
New Delhi
DELHI
110076
India |
| Phone |
|
| Fax |
|
| Email |
director@aiia.gov.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya Kajaria |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
OPD NO 7, Hospital Block, All India Institute of Ayurveda Mathura Rd, Gautam Puri Sarita Vihar New Delhi
South
DELHI
110076
India |
| Phone |
|
| Fax |
|
| Email |
divyakajaria@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prasantha Dharmarajan |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
All India Institute of Ayurveda Mathura Rd
Gautam Puri
Sarita Vihar
New Delhi
South
DELHI
110076
India |
| Phone |
|
| Fax |
|
| Email |
drprasanthd@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda Mathura Rd
Gautam Puri
Sarita Vihar
New Delhi
Delhi
110076 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
Mathura Rd
Gautam Puri
Sarita Vihar
New Delhi
Delhi 110076 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shivani Bansal |
Santosh Medical College and Hospital |
Department of Medicine
1 Ambdkar Rd Opposite Old Bus Stand Maliwara Nehru Nagar
Ghaziabad
Uttar Pradesh 201001
Ghaziabad
UTTAR PRADESH |
9013451039
drshivani2015@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
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. Ayurveda Condition: SANNIPATA-JVAROPADRAVAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Guduchaydi, Reference: Ashtanga Hridyam, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: with lukewarm water), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Standard Symptomatic care | Standard symptomatic care includes antipyretics, vitamins, and minerals and duration will be for 7-10 days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subject aged 20 to 60 years (both inclusive) of both gender
Subject with SARS-CoV-2 infection confirmed through reverse transcription followed by polymerase chain reaction (RT- PCR)
Subject with mild manifestations of COVID-19 (WHO ordinal score 1 or 2)
Subject with oxygen saturation ≥ 95% as measured by pulse oximetry
Subject with initial onset of signs/symptoms attributable to COVID-19 for ≤5 days prior to the day of randomization
Subject with ability to swallow and retain oral medication
Subject with willingness and ability to comply with trial and follow-up procedures
Subject with ability to understand the nature of this trial and give written informed consent
|
|
| ExclusionCriteria |
| Details |
Subject with RT-PCR positive COVID-19 with no symptoms
Subject currently hospitalized or expected to need hospitalization for COVID-19 within 48 hours of randomization
Subject in which the present episode of infection is a recurrence or reinfection of COVID-19 (within 90 days)
Subject having stage 2 hypertension (systolic blood pressure level > 160 mmHg and diastolic blood pressure of > 100 mmHg)
Subject using more than 3 anti-hypertensive drugs
Subject hospitalized for decompensated congestive heart failure in the last 12 months
Subject having HbA1c > 9.0%
Subject having Class 3 obesity (BMI ≥ 40)
Subject with aspartate aminotransferase (AST)/alanine transaminase (ALT) more than 3 times the upper limit of normal reference range
Subject who is pregnant, lactating or planning pregnancy during the study period
Subject of childbearing potential, unwilling to use highly effective contraception during their participation in the trial and for 2 weeks after study completion
Subject with a history of receiving any allopathic or alternative (herbal) medication, any antiviral drugs with reported activity against COVID-19 (ivermectin, favipiravir, hydroxychloroquine, lopinavir, and remdesivir) or warfarin therapy for the present COVID-19 episode within 7 days before enrolment
Subject on steroid or other immunosuppressive medication or having treatment within the last 3 months
Subject with unstable or life-threatening systemic diseases like immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) with cirrhosis, end-stage liver disease, carcinoma, respiratory failure and end stage renal disease
Subject with a platelet count <100,000/μL or who have received a platelet transfusion in the 5 days prior to randomization.
Subject having hypersensitivity or other contraindication to any of the components of the study interventions as determined by the principal investigator.
Subject with conditions that could limit gastrointestinal absorption of tablet contents.
Subject who is already participating in another trial or have received an experimental drug or have used an experimental medical device within 30 days prior to the planned start of procedure
Subject unlikely to comply with the procedure or complete the scheduled follow up visit, in the opinion of principal investigator
Employee of the principal investigator or study center with direct involvement in the proposed study or other studies under the direction of that principal investigator or study center
Other indication-based exclusion, in opinion of principal investigator
|
|
|
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 |
| Time to negative COVID-19 RT-PCR test in subjects having RT-PCR confirmed mild COVID-19 (WHO 8-point Ordinal Scale Score 1 or 2) |
Day-3to-1 Day8to9 Day11-12 Day15 Day30 or early termination visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
subjects with negative RT-PCR confirmed COVID-19 through day 30
Time to decline in viral load
subjects with clinical worsening through day 30
Time from randomization to clinical worsening
subjects getting hospitalized and/or died due to COVID-19 through day 30
subjects admitted to intensive care unit through day 30
subjects who require mechanical ventilation through day 30
subjects who require supplemental oxygen through day 30
Frequency of use of rescue medication through day 30
All-cause mortality within 30 days of randomization
Time from randomization to clinical recovery
COVID-19 antibody titer
Proportion of subjects with appearance of COVID-19 related complications
Subjects’ assessment of treatment satisfaction
Quality of life
subjects with adverse drug reactions and adverse events
subjects who discontinued study intervention due to AE
|
Day-3to-1 Day0 Day1 Day3to4 Day5to6 Day8 to 9 Day11-12 Day15 Day30 or early termination visit |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/09/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The intervention proposed under the project is a polyherbal combination
based on traditional Ayurveda combined with scientific evidence for each
ingredient’s clinical effect in relation to COVID-19. The aim of the study is
to evaluate the efficacy, safety and molecular mechanisms of Guduchyadi
tablets, a polyherbal formulation, in individuals with RT-PCR confirmed mild
COVID-19 through a Phase 2a: Pilot study in India. The combination consists of
well-known Ayurveda herbs along with Tinospora
cordifolia (Guduchi) and this herbal combination is expected to demonstrate
immunomodulatory, antiviral, antipyretic, antitussive, pulmonary protective,
and cardioprotective benefits. Used
together, they are expected to speed recovery from COVID-19-related illness
while reducing complications, providing cardioprotection and improving quality
of life in COVID-19 patients with comorbid conditions. All ingredients of the combination are widely
available in India as nutraceuticals. |