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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
225
Extract from A. Paniculata
Extract from A. Chilensis
Combination of A. Paniculata and A. Chilensis
Placebo comparator
St . George Hospital
Mumbai, Maharashtra, India
Gillurkar Multispecialty Hospital
Nagpur, Maharashtra, India
Shree Hospital & Critical Care Center
Nagpur, Maharashtra, India
Apollo Spectra Hospitals
Kanpur, Uttar Pradesh, India
Shubham Sudbhawana Super Specialty Hospital
Varanasi, Uttar Pradesh, India
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.
Time frame: Day 0, 1, 2, 3, 4, 5, 6, and 7
Time to resolve symptoms
Time to resolution of common cold like symptoms as assessed by participant reporting '0 = not sick' out of 7, for any one day during treatment period as per Wisconsin Upper Respiratory Symptom Survey-21
Time frame: Day 0, 1, 2, 3, 4, 5, 6, and 7
percentage wise severity resolution
Percentage of participants with resolved common cold like complaints at the end of day 7 in comparison to placebo (unresolved participants being those who do not report "0 = not sick" out of 7, as per Wisconsin Upper Respiratory Symptom Survey-21, till the end of treatment period.
Time frame: 7 days
Minimal Important Difference
Percentage of participants achieving minimal important difference of ≥ 10.3 Wisconsin Upper Respiratory Symptom Survey-21 total scores at day 5 and 7 from baseline and in comparison to placebo. Therefore, in the study Minimal important difference will be calculated as the difference of Wisconsin Upper Respiratory Symptom Survey-21 total scores from baseline to day 5 and day 7 and if it is ≥ 10.3, it will be deemed as clinically significant treatment effect.
Time frame: Day 0, 5, and 7
Visual Analogue Scale based severity outcomes
Change in participant's fever and burning eyes sensation severity scores (from 0 to 7 where 0 means not at all severe to 100 means very severe) as assessed by visual analogue scale on day 7 from baseline and in comparison to placebo.
Time frame: Day 0, 1, 2, 3, 4, 5, 6, and 7
Change in symptom resolution
Change in severity of COVID related symptoms (from 0 to 7 where 0 means no symptom to 7 means severe) as assessed by total scores of COVID diary at day 7 and day 15 from baseline and in comparison to placebo.
Time frame: 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)
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