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. 2013 Sep 10;2013(9):CD008642. doi: 10.1002/14651858.CD008642.pub2

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
Interventions I. Treatment group
a. Oral ingestion
1. Fuyang granules
1.1 Ingredients and dosage
  • Cangerzi (Fructus xanthii)

  • Difuzi (Fructus kochiae)

  • Chuangxiong (Rhizoma chuanxiong)

  • Honghua (Flos carthami)

  • Baiying (Herba solani lyrati)

  • Did not provide dosage of the ingredients


1.2 Administration
  • Oral ingestion 2.25 to 3 g of the granules, twice daily


1.3 Duration of treatment
  • 5 days


1.4 Follow up
  • Did not state


b. Topical application
  • Used the remaining solution of the oral ingestion intervention for external application


II. Control group
a. Oral ingestion
2. Cyproheptadine tablet
2.1 Ingredients and dosage
  • Cyproheptadine 0.25 mg


2.2 Administration
  • 3 times daily oral ingestion


2.3 Duration of treatment
  • 5 days


2.4 Follow up
  • Did not state


b. Topical application
2. Sulphur cream
2.1 Ingredients and dosage
  • 3% sulphur cream


2.2 Administration
  • Applied the cream topically, did not state how often it was applied


2.3 Duration of treatment
  • 5 days


2.4 Follow up
  • Did not state

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
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