AN OPEN LABEL, NON-RANDOMISED, CLINICAL STUDY TO EVALUATE THE EFFICACY OF HOMEOPATHIC FORMULATION OF ANACOSINUM PELLETS IN PATIENT WITH FLU AND FLU LIKE SYMPTOMS

Dr. Anjali Amol Sable, Ms. Pragya Singh, Drx Rajeshwari S. Sorte

Abstract


Background:

Influenza is a highly infectious, but relatively benign viral disease which is particularly common in the winter months. Influenza is a highly infectious and prevalent viral disease that is particularly common in the autumn and winter months in temperate regions of the world. Flu symptoms include fever between 38° C and 40° C (about 100-104 °F) or higher, muscle and joint pain throughout the entire body (myalgia and arthralgia), headache, severe fatigue, dry cough, stuffy and/or runny nose, lack of appetite and extreme tiredness. The common cold is distinct from flu, associated with the influenza virus. A fever greater than 38°C and generalized aches and pains are the best predictors of a diagnosis of the flu. The primary outcome of this study is to assess efficacy Anacosinum pellets in the condition of Flu and overall compliance to the drug treatment. The secondary outcome is to assess the efficacy of Anacosinum Pellets by Symptomatic relief from clinical symptoms of Flu and mean change in Visual Analog Scale (VAS) Chart score.

Methods:

This study was an open Label, non-randomized, clinical study to evaluate the efficacy of homeopathic formulation of “Anacosinum tablet” in a patient with Flu and Flu like symptoms. The inclusion criteria were adult above 18 years to below 60 years, both male and female. All eligible subjects who meet the Inclusion and Exclusion was enrolled into the study were visiting the study  site on Screening, Day 0 (Baseline Visit) and Day 7. The 200 Subjects were enrolled in this study. The primary endpoint was percentage change (increase/ decrease) in baseline as compared to day seven was analyzed using chi- square with Pearson’s test. The secondary endpoint of Anacosinum Pellets was the symptomatic relief from clinical symptoms of Flu and improvement in the health status. The secondary endpoint was analyzed using descriptive statistics. The p- value (p=NS) for vital measures was found not to be statistically significant.

Results:

A total of 200 samples was included in this study among them, 78 (39%) were female and 122 (61%) were male patients. The average age was 29.61± 10.45 (range, 18-60) years. The mean  change in vital measure was found statistically significant (≤0. 05). A summary of adverse events, was not occurring during the treatment. The results show that significant decrease in body temperature, Sore throat, Sneezing/ Nasal irritation. Headache, Cough, Runny Nose, Malaise. The Efficacy results of this study had shown more significant results with Anacosinum pellets.

Conclusion:

Anacosinum pellets at a dose of 1 vial thrice a day Before food for 7 days was more efficacious. The adverse event and also the serious adverse event were not found in this study. This particular data is much in need, due to which it will bring the positive effects of this medicine to worldwide physicians so that more patients of flu and flu like symptoms are benefitted. The body temperature and the Flu related symptoms were not worsened during the treatment. The incidence rate of serious adverse event and adverse event were not reported. Hence, it's proven the tolerability of this drug Anacosinum pellet.


Keywords


NON-RANDOMISED, Visual Analog Scale (VAS), Inuenza

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References


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