A Randomized, Open Label, Multicentre Study to Evaluate the Safety and Efficacy of Cough Mixture CS1 (Pholcodeine and Promethazine - Tixylix) Versus CS2 (Noscapine, Ammonium Chloride, Sodium Citrate) in Treatment of Children with Dry Cough.
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Date
2012-06
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Abstract
The objective of this study was to compare the efficacy
and safety of cough mixture containing pholcodeine and
promethazine - Tixylix (CS1) to a cough mixture which has
noscapine, ammonium chloride, and sodium citrate (CS2) as
its constituents in treatment of children suffering from dry
cough. A total of 208 patients were enrolled at 4 sites. Of
these, 179 (94 receiving CS1 and 99 receiving CS2) completed
the study. Results of this study suggest that both the cough
mixtures were comparable as per evaluation of their primary
parameters. According to global assessment for efficacy and
tolerability by parents on Day 7, Group CS1 performed better
than CS2. It was also observed that no AE was reported in
Group CS1 as compared to 2 AEs in Group CS2. To conclude,
cough mixture combination of pholcodeine and promethazine
- Tixylix exhibited efficacy and safety that was comparable
with cough mixture which has noscapine, ammonium chloride,
and sodium citrate. It was proven to be efficacious, safe and
well tolerated in the select population.
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Keywords
dry cough, children, pholcodeine, promethazine
Citation
Mukaddam Qayum, Naik Manoj, Khandeparkar Prashant, Prabhu Manoj. A Randomized, Open Label, Multicentre Study to Evaluate the Safety and Efficacy of Cough Mixture CS1 (Pholcodeine and Promethazine - Tixylix) Versus CS2 (Noscapine, Ammonium Chloride, Sodium Citrate) in Treatment of Children with Dry Cough. Indian Medical Gazette. 2012 Jun ; 145 (6): 237-245.