A Double-blind, Randomized, Placebo-Controlled, Comparative Study for Assessing the Efficacy and Tolerability of A. Paniculata/A. Chilensis in Individuals With Upper Respiratory Tract Infections
Overview
- Phase
- Phase 3
- Intervention
- A. Paniculata
- Conditions
- Upper Respiratory Tract Infection
- Sponsor
- Vedic Lifesciences Pvt. Ltd.
- Enrollment
- 225
- Locations
- 5
- Primary Endpoint
- Severity Outcome
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Detailed Description
The common cold is one of the most frequent minor illnesses in the world. A large US-American survey showed that over 70% of the population annually was suffering from at least one viral respiratory tract infection. Also the economic burden in the USA was almost USD 40 billion annually causing considerable direct and indirect healthcare costs. Caused by 200 identified types of viruses, the common cold is primarily associated with rhinoviruses. Common cold symptoms may include sore throat, runny nose, general malaise, and low-grade fever at onset, followed by nasal congestion and cough. While benign, they last for several days and cause 40% of all missed work days. Complications also include sinusitis, otitis media and pneumonia, exacerbations of asthma and chronic obstructive pulmonary disease, and serious illness in immunocompromised patients. Colds typically afflict most adults and adolescents 2-4 times a year and symptoms usually peak around day 3 or 4 and last 1-2 weeks with a median of 7 days. There is no approved specific therapy for URTI, treatment is therefore mainly symptomatic. The most common pharmacological treatments are antipyretics, anti-inflammatory drugs, expectorants, decongestants, and cough suppressants, either alone or in combination. Supportive measures can include bed rest, hot baths, and inhalations, gargling, and drinking plenty of fluids. Antibiotics are widely prescribed, but often is inappropriate because URTI are mostly caused by viruses and are only indicated in the case of bacterial infection. Its overuse can also lead to the development of community acquired resistant pathogens which are an increasing and serious health burden.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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/m
- •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-
- •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 \<
- •Those who demonstrate an understanding of the study details and have a willingness to participate, as evidenced by voluntary written informed consent.
Exclusion Criteria
- •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.
Arms & Interventions
A. Paniculata150 mg
Extract from Andrographis Paniculata
Intervention: A. Paniculata
A. Chilensis 300 mg
Extract from A. Chilensis
Intervention: A. Chilensis
A. Panicluata 150 mg + A. Chilensis 300 mg.
combination of extract of A. Paniculata and A. Chilensis
Intervention: A. Paniculata and A. Chilensis
Microcrystalline Cellulose +/-450 mg
Comparator
Intervention: Microcrystalline cellulose
Outcomes
Primary Outcomes
Severity Outcome
Time Frame: Day 0, 1, 2, 3, 4, 5, 6, and 7
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.
Secondary Outcomes
- 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))