Background: Acute coryza or common cold affects the upper airways, sometimes in association with low-grade fever and systemic symptoms, and usually presents with at least two of the following symptoms: cough, dysphonia, throat discomfort, sore throat, nasal congestion, rhinorrhoea, sneezing, headaches, myalgia and fever. A triple combination of analgesics, decongestants and antihistamines provides better relief for multiple symptoms in common cold and allergic rhinitis according to various studies. A combination of Paracetamol as an analgesic, anti-inflammatory and antipyretic, Chlorpheniramine maleate, an anti-histaminic and Phenylephrine as a nasal decongestant is popular in the treatment of common cold. Hence the present study was planned to evaluate efficacy and safety of this combination in treatment of common cold.Methods: This was a phase IV, open-labelled, multicentric study in 159 patients. Efficacy assessment was done by analyzing the reduction in mean TSS at each follow-up visit and safety assessment was done by analyzing the adverse events during the study.Results: There was reduction in mean TSS from 6.62 (day 1) to 3.56 (day 3) and 0.69 (day 5). Most of the patients had >50% reduction in total symptom score at visit 3 and 58.49% patients had complete relief from the symptoms at the end of study. Out of 159 patients, 26 i.e. 16.36% experienced adverse events. Sedation and drowsiness (6.29%) were the most common adverse event seen in patients.Conclusions: A fixed dose combination of Chlorpheniramine maleate, Paracetamol, and Phenylephrine is safe and effective in the treatment of common cold.

Background: Cough is one of the most common symptom that most of the Doctors faces while practising in paediatric population. Cough can be productive or unproductive. Productive cough can be treated with the combination of bronchodilator, expectorant and mucolytics. The main objective of the Phase IV clinical trial conducted was to test the efficacy and safety for the combination of Levosalbutamol (bronchodilator), Ambroxol Hydrochloride (mucolytic agent) and Guaifenesin (expectorant) for the treatment of productive cough associated with bronchospasm in conditions such as bronchitis and bronchial asthma as well as all conditions associated with tenacious mucus, wheezing and chest congestion. Methodology: The trial was conducted with 23 paediatric speciality Doctors on 325 patients out of which 149 patients were of age group 2 to 12 years and 176 were of age below 1 year. Efficacy assessment was done by analysing the cough severity score at all the visits. Safety assessment was done by analysing the adverse events experienced by the patients or observed by the investigators at all the visits. Results: At baseline, CSS was 6.624 reduced to 3.744 at day 3 and 1.049 at day 5. One point reduction in Likert type symptom scale from moderate to mild was in just 5 days. Only 12.923 % of patients experienced non-serious adverse events. Conclusion: Combination of Levosalbutamol, Ambroxol Hydrochloride and Guaifenesin was safe as well as efficacious for the treatment of productive cough.

Introduction: Common cold is frequently encountered by people and it also largely affects productivity of the daily routine life. Combination of Paracetamol, Phenylephrine and Chlorpheniramine maleate which acts as an antipyretic, nasal decongestant and anti-histaminic respectively, can be used for the symptomatic treatment of common cold. To the above-mentioned combination, Sodium Citrate was added as an expectorant and Menthol for cooling effect and this post marketing surveillance study was conducted to test the efficacy and safety for the symptomatic treatment of common cold. Methodology: Out of 200 enrolled, 174 patients completed the study. Safety assessment was made by analysing the adverse events reported by the patient or their guardian. Efficacy was evaluated by total symptom score [TSS] (eleven-point scale ranging from 0 to 10 where 0 is no symptom to 10 is the maximum symptoms) which was extrapolated to four-point Likert-type symptom severity scales. Results: TSS was reduced from 5.57 at baseline visit to 3.40 at day 3 to 1.69 at day 5. At day 3 and day 5 there was TSS reduction of 38.865 % and 69.690 % respectively as compared to baseline. 18 episodes of adverse drug reactions were reported and all of them were of expected and non-serious nature. Conclusion: Fixed-dose combination of Paracetamol 125mg, Phenylephrine 5mg, Chlorpheniramine Maleate 1mg, Sodium Citrate 60mg and mentholated flavoured syrupy base q.s. per 5ml was found to be safe and efficacious for the treatment of common cold in children of age between 2 to 12 years.

Introduction: Common cold is Self-recovering respiratory diseases which can be caused by viral infection. As till date there is no treatment for the common cold and it is self-limiting in nature, symptomatic treatment is the only option. Symptomatic treatment of common cold with a single drug is not efficacious as compared to the multiple drug combination. Combination of antipyretic (Paracetamol), nasal decongestant (Phenylephrine) and anti-histaminic agent (Chlorpheniramine Maleate) can be used for the symptomatic treatment of common cold. This post marketing surveillance study was conducted to test the efficacy and safety for the fixed dose combination of Paracetamol 125mg, Phenylephrine Hydrochloride 2.5mg and Chlorpheniramine Maleate 1mg per ml in Indian patients of age 1 to 12 months. Methodology: Out of 200 enrolled, 164 patients completed the study. Efficacy was evaluated by total symptom score (TSS) ranging from 0 to 10 where 0 was no symptom to 10 was the maximum tolerated symptoms. TSS was further extrapolated to four-point-Likert-type-symptom-severity-scale. Safety assessment was done by evaluation of adverse events reported by the patient. Results: TSS was reduced from 5.91 on day 1 to 3.57 on day 3 and 1.47 on day 5. At day 3 and day 5 the percentage reduction in the TSS as compared to the baseline was 39.48 and 75.05 respectively. During the study only 8 episodes of ADRs were reported including sedation and drowsiness. Conclusion: Combination of Paracetamol, Phenylephrine and Chlorpheniramine Maleate was found to be efficacious and safe for the treatment of common cold and allergic rhinitis. Keywords: Paracetamol, Phenylephrine, Chlorpheniramine Maleate, Common Cold, Allergic Rhinitis.

Objective: S. boulardii seem to be an assuring biotherapeutic agent for the amelioration of the course of diarrhoea in children when used therapeutically. S. boulardii mediates responses resembling the protective effects of the normal healthy gut flora. Our objective was to access the safety and efficacy of S. boulardii on childhood diarrhea. Methodology: Total 210 patients were enrolled out of which 184 patients completed the study S. boulardii sachets (5 million CFU~282.5mg) were given to the patients enrolled in the study. Efficacy and safety assessment was made by quantitating the Frequency, Intensity and Consistency of stools. Results: Stool frequency decreased from 9.005 to 2.7 at the end of 5 days. Severity scale was extrapolated which interestingly showed zero patients with severe diarrhoea. There was a reduction in the duration of diarrhoea along with stool consistency where in majority patients with watery stool came down to 2 from 136. Conclusions: Saccharomyces boulardii is safe and efficacious in the treatment of diarrhoea in Indian children.