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Efficacy and safety of Gantong Granules in the treatment of common cold with wind-heat syndrome: study protocol for a randomized controlled trial.

Min J, Li XQ, She B, Chen Y, Mao B - Trials (2015)

Bottom Line: However, there is a lack of robust evidence to support the clinical utility of such a treatment.The primary outcome is the duration of all symptoms.Secondary outcomes include the duration of primary symptoms and each symptom, time to fever relief and time to fever clearance, change in TCM symptom score, and change in Symptom and Sign Score.

View Article: PubMed Central - PubMed

Affiliation: Department of Integrated Traditional and Western Medicine, West China Hospital of Sichuan University, 37 Guoxue Lane, Chengdu, 610041, Sichuan Province, People's Republic of China. jane_min51@hotmail.com.

ABSTRACT

Background: Although the common cold is generally mild and self-limiting, it is a leading cause of consultations with doctors and missed days from school and work. In light of its favorable effects of relieving symptoms and minimal side-effects, Traditional Chinese Medicine (TCM) has been widely used to treat the common cold. However, there is a lack of robust evidence to support the clinical utility of such a treatment. This study is designed to evaluate the efficacy and safety of Gantong Granules compared with placebo in patients with the common cold with wind-heat syndrome (CCWHS).

Methods/design: This is a multicenter, phase IIb, double-blind, placebo-controlled and randomized clinical trial. A total of 240 patients will be recruited, from 5 centers across China and randomly assigned to the high-dose group, medium-dose group, low-dose group or placebo control group in a 1:1:1:1 ratio. All subjects will receive the treatment for 3 to 5 days, followed by a 7-day follow-up period. The primary outcome is the duration of all symptoms. Secondary outcomes include the duration of primary symptoms and each symptom, time to fever relief and time to fever clearance, change in TCM symptom score, and change in Symptom and Sign Score.

Discussion: This trial will provide high-quality evidence on the efficacy and safety of Gantong Granules in treating CCWHS, and help to optimize the dose selection for a phase III clinical trial.

Trial registration: The registration number is ChiCTR-TRC-14004255 , which was assigned by the Chinese Clinical Trial Registry on 12 February 2014.

No MeSH data available.


Related in: MedlinePlus

Symptom and Sign Scoring system.
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Fig3: Symptom and Sign Scoring system.

Mentions: The TCM symptom score system used in the study follows the Guidelines for Clinical Research of New Chinese Medicine [19], in which all symptoms are given graded scores (Figure 3). TCM signs will also be assessed, but not scored. The sum of all symptom scores is the cumulative TCM symptom score. The change in cumulative TCM symptom score is assessed by the percentage of symptom score reduction (PSSR), which is calculated according to the following formula:\documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$$ \mathrm{PSSR}\kern0.5em =\kern0.6em \left(\frac{symptom\ score\ before\ treatment\hbox{-} symptom\ score\ after\ treatment}{symptom\ score\ before\ treatment}\right)\kern0.5em \times \kern0.5em 100\% $$\end{document}PSSR=symptomscorebeforetreatment‐symptomscoreaftertreatmentsymptomscorebeforetreatment×100%Figure 3


Efficacy and safety of Gantong Granules in the treatment of common cold with wind-heat syndrome: study protocol for a randomized controlled trial.

Min J, Li XQ, She B, Chen Y, Mao B - Trials (2015)

Symptom and Sign Scoring system.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4488979&req=5

Fig3: Symptom and Sign Scoring system.
Mentions: The TCM symptom score system used in the study follows the Guidelines for Clinical Research of New Chinese Medicine [19], in which all symptoms are given graded scores (Figure 3). TCM signs will also be assessed, but not scored. The sum of all symptom scores is the cumulative TCM symptom score. The change in cumulative TCM symptom score is assessed by the percentage of symptom score reduction (PSSR), which is calculated according to the following formula:\documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$$ \mathrm{PSSR}\kern0.5em =\kern0.6em \left(\frac{symptom\ score\ before\ treatment\hbox{-} symptom\ score\ after\ treatment}{symptom\ score\ before\ treatment}\right)\kern0.5em \times \kern0.5em 100\% $$\end{document}PSSR=symptomscorebeforetreatment‐symptomscoreaftertreatmentsymptomscorebeforetreatment×100%Figure 3

Bottom Line: However, there is a lack of robust evidence to support the clinical utility of such a treatment.The primary outcome is the duration of all symptoms.Secondary outcomes include the duration of primary symptoms and each symptom, time to fever relief and time to fever clearance, change in TCM symptom score, and change in Symptom and Sign Score.

View Article: PubMed Central - PubMed

Affiliation: Department of Integrated Traditional and Western Medicine, West China Hospital of Sichuan University, 37 Guoxue Lane, Chengdu, 610041, Sichuan Province, People's Republic of China. jane_min51@hotmail.com.

ABSTRACT

Background: Although the common cold is generally mild and self-limiting, it is a leading cause of consultations with doctors and missed days from school and work. In light of its favorable effects of relieving symptoms and minimal side-effects, Traditional Chinese Medicine (TCM) has been widely used to treat the common cold. However, there is a lack of robust evidence to support the clinical utility of such a treatment. This study is designed to evaluate the efficacy and safety of Gantong Granules compared with placebo in patients with the common cold with wind-heat syndrome (CCWHS).

Methods/design: This is a multicenter, phase IIb, double-blind, placebo-controlled and randomized clinical trial. A total of 240 patients will be recruited, from 5 centers across China and randomly assigned to the high-dose group, medium-dose group, low-dose group or placebo control group in a 1:1:1:1 ratio. All subjects will receive the treatment for 3 to 5 days, followed by a 7-day follow-up period. The primary outcome is the duration of all symptoms. Secondary outcomes include the duration of primary symptoms and each symptom, time to fever relief and time to fever clearance, change in TCM symptom score, and change in Symptom and Sign Score.

Discussion: This trial will provide high-quality evidence on the efficacy and safety of Gantong Granules in treating CCWHS, and help to optimize the dose selection for a phase III clinical trial.

Trial registration: The registration number is ChiCTR-TRC-14004255 , which was assigned by the Chinese Clinical Trial Registry on 12 February 2014.

No MeSH data available.


Related in: MedlinePlus