To Compare the Efficacy and Tolerability of A. Paniculata/A. Chilensis in Individuals With URTI
Condition: Upper Respiratory Tract Infection
MeSH terms: Infections; Respiratory Tract Infections
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): A. Paniculata; A. Chilensis; A. Paniculata and A. Chilensis; Microcrystalline cellulose
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Extract from A. Paniculata; Extract from A. Chilensis; Combination of A. Paniculata and A. Chilensis; Placebo comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment