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To Compare the Efficacy and Tolerability of A. Paniculata/A. Chilensis in Individuals With URTI

NCT04955327 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2022-05-10

No results posted yet for this study

Summary

Conventional therapy of upper respiratory tract infection (URTI) is not always effective and sometimes leads to side effects and also to inappropriate use of antibiotic. Hence, a search for safe and effective further treatment options is justified and would be a welcome addition to available conventional treatment. Use of plant based dietary supplements has become increasingly popular over the last few decades or so. Research based on some plants is more than centuries old and its main therapeutic objective is to stimulate the self-healing power of the body. Andrographolide was docked successfully in the binding site of SARS-CoV-2 Mpro. Computational approaches also predicts this molecule to have good solubility, pharmacodynamics property and target accuracy. This molecule also obeys Lipinski's rule, which makes it a promising compound to pursue further biochemical and cell based assays to explore its potential for use against COVID-19. A. Paniculata is a patented extract, standardized to Andrographolide, 14-deoxyandrographolide, and Neo-andrographolide. Maqui contains Maqui Berry Extract of Aristotelia Chilensis (10% Anthocyanidin, 8% Delphinidin) belonging to the family of Elaeocarpaceae, which has been known for its use in several conditions such as sore throat, fever and several other ailments. In the present study, the therapeutic potential of Andrographis Paniculata and Aristotelia chilensis as single ingredients as well as in combination will be evaluated in participants with common cold and COVID related symptoms. The products to be evaluated have been rigorously standardized and are available under the brand names of A. Paniculata and A. Chilensis. Literature indicates that both A. Paniculata and A.Chilensis are effective and safe in the treatment of typical cold-related symptoms in adults.

Conditions

Interventions

DRUG

A. Paniculata

Extract from A. Paniculata

DRUG

A. Chilensis

Extract from A. Chilensis

DRUG

A. Paniculata and A. Chilensis

Combination of A. Paniculata and A. Chilensis

DRUG

Microcrystalline cellulose

Placebo comparator

Sponsors & Collaborators

  • Vedic Lifesciences Pvt. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-20
Primary Completion
2022-02-25
Completion
2022-02-25

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04955327 on ClinicalTrials.gov