CTRI/2022/07/044204 [Registered on: 21/07/2022] Trial Registered Prospectively
Last Modified On:
08/05/2023
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Ayurveda
Study Design
Other
Public Title of Study
To study the effect of herbal formulation in the management of newly diagnosed mild COVID-19 patients, to reduce the risk of hospitalization or death.
Scientific Title of Study
Effect of Guduchyadi tablet (Tinospora based herbal formulation) in the management of newly diagnosed mild COVID-19 patients, to reduce the risk of hospitalization or death: A randomized double-blind placebo-controlled trial
Meditrina Institute Ethics Committee,278 Central Bazar Road,Ramdaspeth, Nagpur, Maharashtra 440010
Approved
Penta Med Ethics Committee, Medipoint Hospitals, Aundh, Pune
Approved
S2J Independent Ethics Committee (S2J IEC), Pride Hospitals, Hyderabad
Approved
Society for Research Welfare, Maggo Hospital, Uttam Nagar, Delhi- 110059
Approved
Society for Research Welfare, Santosh Medical College and Hospital, Ghaziabad, Uttar Pradesh-201009 Santosh Hospital,
Approved
Society for Research Welfare, Silver Streak Hospital, Sector 87, Gurugram, 122505, Haryana
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, (2) 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
Comparator Arm
Drug
Classical
(1) Medicine Name: Guduchyadi tablets plus standard supportive care, 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: -
Placebo group will receive tablets with identical looks and feels along with the standard supportive care. Placebo group will receive tablets with identical looks and feels, composed of starch, aerosol, magnesium stearate and color. Placebo tablets will also be administered at a dose of 1000 mg (2 tablets of 500 mg each), one hour before food, three times a day (morning, afternoon and night), orally with warm water for ten days along with the standard supportive care. Standard supportive care w
Subject aged 18 to 70 years (both inclusive) of both gender
Subject with SARS-CoV-2 infection confirmed through reverse transcription followed by polymerase chain reaction (RT- PCR)
RT PCR negative COVID 19 suspected symptomatic subject defined as having strong suspicion of atleast 3 or more symptoms as per WHO or ICMR compatible with covid 19 and or having exposure to Covid 19 cases
Subject with mild manifestations of COVID-19 (ICMR guidelines, 2022)
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 who is currently hospitalized or is expected to need hospitalization for COVID-19 within 48 hours of randomization.
Subject with moderate, severe and critical COVID-19 (ICMR guidelines, 2022)
Subject in which the present episode of infection is a recurrence or reinfection of COVID-19 (within 90 days)
Subject with underlying non-Communicable diseases like cardiovascular disease, hypertension, and CAD, DM (Diabetes Mellitus) and other immunocompromised states, active tuberculosis, chronic lung/kidney/liver disease, cerebrovascular diseases and obesity
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 on steroid or other immunosuppressive medication
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 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
Pre-numbered or coded identical Containers
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
Percentage of participants with mild COVID-19 (as per ICMR guidelines, 2022) who are hospitalized and/or die due to COVID-19 through day 30
Day 1, Day 3, Day 5, Day 11-12,Day 15, Day 30/early termination visits
Secondary Outcome
Outcome
TimePoints
1.Proportion of subjects with clinical worsening from baseline severity of COVID 19
2.Time from randomization to clinical worsening
3.All-cause mortality within 30 days of randomization
4.Proportion of subjects admitted to intensive care unit through day 30
5.Proportion of subjects who require mechanical ventilation through day 30
6.Proportion of subjects who require supplemental oxygen through day 30
7.Frequency of use of rescue medication through day 30
8.Time (in days) from randomization to clinical recovery
9.Proportion of subjects with negative RT-PCR test for COVID-19 through day 30
10.Time from randomization to negative COVID-19 RT-PCR test
11.Time (in days) to decline in viral load
12.Subjects’ assessment of treatment satisfaction
13.Quality of life by WHO QOL questionnaire
14.Percentage of subjects with appearance of COVID-19 related complications
Day 0, Day 1, Day 3, Day 5, Day 11-12, Day 15, Day 30/early termination visits
Target Sample Size
Total Sample Size="750" Sample Size from India="750" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
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 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. All ingredients of the combination are widely available in India as over-the-counter medicines or food products, and as food supplements in other countries like USA etc. The aim of this research study is to evaluate the effect of Guduchyadi tablets, a polyherbal formulation, on individuals with newly diagnosed mild COVID-19 infection through a phase 3 multi-centric clinical trial in India. This proposed therapeutic intervention to address COVID-19 related situations in the population with mild COVID-19 is expected to improve their quality of life, reduce clinical recovery time, and reduce the need for hospitalization.