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

NCT04955327 | Completed Phase 3

• 1 other identifier: HP/200802/PARACTIN/CC
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 5

Brief 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

Upper Respiratory Tract Infection

Outcome Measures

Primary Outcomes (1)

• Severity Outcome

  Change in total symptom severity scores from 0 to 7 (where 0 means not sick to 7 means severe) as assessed by Wisconsin Upper Respiratory Symptom Survey-21 on day 7 from baseline and in comparison to placebo.

  Day 0, 1, 2, 3, 4, 5, 6, and 7

Secondary Outcomes (5)

• Time to resolve symptoms

  Day 0, 1, 2, 3, 4, 5, 6, and 7

• percentage wise severity resolution

  7 days

• Minimal Important Difference

  Day 0, 5, and 7

• Visual Analogue Scale based severity outcomes

  Day 0, 1, 2, 3, 4, 5, 6, and 7

• Change in symptom resolution

  Day 0 to day 7 (for all COVID +ve participants) and Day 8 to day 15 (For COVID participants who didn't turn negative on day 8)

Study Arms (4)

A. Paniculata150 mg

EXPERIMENTAL

Extract from Andrographis Paniculata

Drug: A. Paniculata

A. Chilensis 300 mg

EXPERIMENTAL

Extract from A. Chilensis

Drug: A. Chilensis

A. Panicluata 150 mg + A. Chilensis 300 mg.

EXPERIMENTAL

combination of extract of A. Paniculata and A. Chilensis

Drug: A. Paniculata and A. Chilensis

Microcrystalline Cellulose +/-450 mg

PLACEBO COMPARATOR

Comparator

Drug: Microcrystalline cellulose

Interventions

A. Paniculata DRUG

Extract from A. Paniculata

A. Paniculata150 mg

A. Chilensis DRUG

Extract from A. Chilensis

A. Chilensis 300 mg

A. Paniculata and A. Chilensis DRUG

Combination of A. Paniculata and A. Chilensis

A. Panicluata 150 mg + A. Chilensis 300 mg.

Microcrystalline cellulose DRUG

Placebo comparator

Microcrystalline Cellulose +/-450 mg

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Males and females aged between 18 and 50 years, complete as of the screening date.
• Participants with symptoms of acute upper respiratory tract infection as assessed by the investigator at the time of screening.
• Participants with BMI ≤ 29.9 kg/m2.
• Upper respiratory tract infection symptoms present for at least 24 hours but not more than 72 hours prior to screening visit.
• Those having a score of ≥ 5 for at least 2 symptoms out of runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough or head congestion on the Wisconsin Upper Respiratory Symptom Survey-21.
• Participants not requiring hospitalization.
• Participants with COVID +ve/ COVID -ve RT-PCR report.
• SPO2 level ≥ 90%
• Systolic blood pressure \< 130 mm Hg and/or diastolic blood pressure \< 90.
• Those who demonstrate an understanding of the study details and have a willingness to participate, as evidenced by voluntary written informed consent.
• Must be literate and have the ability to complete the study-based questionnaires and requirements.

You may not qualify if:

• High grade fever defined as body temperature ≥ 40°C.
• With a history of allergy (allergic rhinitis) along with symptoms such as sneezing, runny nose and red, watery and itchy eyes.
• Chest X-ray showing signs of pneumonia.
• Participants with history of chronic obstructive pulmonary disease, pulmonary fibrosis or asthma
• Participants with rhinitis medicamentosa, chronic cough of bacterial, fungal or other known origin.
• Participants with anatomical nasal obstruction/ deformity or nasal reconstructive surgery etc.
• Participants with history of heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies.
• Participants with history of immunocompromised state immune system with/ without organ transplant.
• Participants with known or suspected hypersensitivity or intolerance to herbal products.
• Alanine transaminase (ALT) or aspartate transaminase (AST) ≥ 2.0 times the upper limit of normal.
• Participants diagnosed with Sickle cell disease, Thalassemia, Type I/ II diabetes mellitus, cystic fibrosis.
• Diagnosed cases of hypertension.
• Those not willing to abstain from home based cold remedies that include but are not limited to steam inhalation, decoctions, vapour rub, ginger tea, honey tea, decoctions, or any form of dietary supplements during the entirety of study participation period.
• Those who have been vaccinated for influenza, swine flu or COVID three months prior to screening visit.
• Those who have taken or should be taking or are taking antibiotics, antivirals, steroids, nasal decongestants, antihistamines or other medications that are expected to alleviate cold symptoms within one week of the start of the study.

Sponsors & Collaborators

• Vedic Lifesciences Pvt. Ltd.: lead

Study Sites (5)

St . George Hospital

Mumbai, Maharashtra, 400001, India

Location

Gillurkar Multispecialty Hospital

Nagpur, Maharashtra, 440009, India

Location

Shree Hospital & Critical Care Center

Nagpur, Maharashtra, 440009, India

Location

Apollo Spectra Hospitals

Kanpur, Uttar Pradesh, 208001, India

Location

Shubham Sudbhawana Super Specialty Hospital

Varanasi, Uttar Pradesh, 221005, India

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

Andrographis paniculata extract; microcrystalline cellulose

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: July 8, 2021
• Study Start: March 20, 2021
• Primary Completion: February 25, 2022
• Study Completion: February 25, 2022
• Last Updated: May 10, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (5)