Tian 2005.
Methods | This was a randomised, controlled, parallel clinical trial | |
Participants | 1. Setting: The trial recruited participants from an outpatient department of dermatology in a hospital in Yingkou, China 2. Age: children (age not stated) 3. Sex (men/women): 71/29 4. Number of participants randomised: 100 5. T/C: 58/42 |
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Interventions |
I. Treatment group a. Oral ingestion 1. Fuyang granules 1.1 Ingredients and dosage
1.2 Administration
1.3 Duration of treatment
1.4 Follow up
b. Topical application
II. Control group a. Oral ingestion 2. Cyproheptadine tablet 2.1 Ingredients and dosage
2.2 Administration
2.3 Duration of treatment
2.4 Follow up
b. Topical application 2. Sulphur cream 2.1 Ingredients and dosage
2.2 Administration
2.3 Duration of treatment
2.4 Follow up
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Outcomes | 1. Effectiveness rate developed by the trial investigators 2. Adverse events Assessments were measured at baseline and at the end of the 5‐day treatment period |
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Notes | ‐ | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | This was not stated |
Allocation concealment (selection bias) | Unclear risk | This was not stated |
Blinding of participants and personnel (performance bias) All outcomes | High risk | This was not stated Comment: The appearance and administration of the 2 interventions were different, so it is unlikely that a blinding method was used |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | This was not stated |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | This was not stated Comment: The numbers of participants randomised and analysed were equivalent. It seems that there were no withdrawals/dropouts in this study |
Selective reporting (reporting bias) | Unclear risk | There was insufficient information |
Other potential sources of bias (use of published validated scoring system ) | High risk | The trial did not use a published validated scoring system |