Clinical Trial: A Comparative Efficacy and Safety Study of Compound Carraghenates Cream With Mayinglong Musk Hemorrhoid Ointment in the Treatment of Hemorrhoids

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Comparative Clinical Research on Therapeutic Effect and Safety of Compound Carraghenates Cream Versus Mayinglong Musk Hemorrhoid Ointment in the Treatment of

Brief Summary: The purpose of this study is to compare the therapeutic effect and safety of compound carraghenates cream with Mayinglong musk hemorrhoid (swollen veins in the lower part of the rectum or anus) ointment in the treatment of hemorrhoids, especially regarding the relief of pain.

Detailed Summary: This is an open-label (all people know the identity of the intervention), randomized (study drug assigned by chance), multi-center (when more than one hospital or medical school team work on a medical research study), controlled clinical trial and comparative study of safety and efficacy of compound carraghenates cream with Mayinglong musk hemorrhoid ointment in the treatment of hemorrhoids, especially regarding the relief of pain. Participants will be randomly assigned to either of the two treatment groups that are carraghenates cream (Titanoreine) group or Mayinglong musk hemorrhoid ointment group. The total duration of the study will be 1 Week (7 days). In carraghenates cream group, 3-4 gram (g) cream will be administered each time through anal canal, twice a day, once in the morning and once in the evening for consecutive 6 days and in the Mayinglong musk hemorrhoid ointment group, 2 g ointment will be administered each time through anal canal, twice a day, once in the morning and once in the evening for consecutive 6 days. Efficacy will be assessed by using Numeric Rating Scale (NRS) and participants' safety will be monitored throughout the trial.
Sponsor: Xian-Janssen Pharmaceutical Ltd.

Current Primary Outcome:

• Pain Acting Time [ Time Frame: Day 1 up to Day 7 ]
  The time from the first administration of the drugs to the time when the participant feels that his (her) pain has been remitted remarkably will be assessed.
• Pain Intensity Score at Day 4 [ Time Frame: Day 4 ]
  Pain intensity will be measured on an 11-point numeric rating scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates intense pain. Grade 1-4 represents mild pain, Grade 5-6 moderate pain, and Grade 7-10 serious pain. Higher score indicates worsening.
• Pain Intensity Score at Day 7 [ Time Frame: Day 7 ]
  Pain intensity will be measured on an 11-point numeric rating scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates intense pain. Grade 1-4 represents mild pain, Grade 5-6 moderate pain, and Grade 7-10 serious pain. Higher score indicates worsening.
• Daily Duration of Symptoms [ Time Frame: Day 1 up to Day 7 ]
  The accumulated time of the onset of all symptoms in the same day will be assessed. The baseline value before the administration of the drugs is the accumulated time of the occurrence of all symptoms in the day prior to the visit.
• Frequency of Defecation [ Time Frame: Day 1 up to Day 7 ]
  The daily frequency of defecation for the day prior to the visit and each day during the trial period will be assessed.
• Participants' Satisfaction for the Treatment [ Time Frame:&n
  
  

  Original Primary Outcome: Same as current
  
  

  Current Secondary Outcome:
  
  

  Original Secondary Outcome:
  
  Information By: Xian-Janssen Pharmaceutical Ltd.
  

  Dates:
  Date Received: June 14, 2013
  Date Started: December 2006
  Date Completion:
  Last Updated: February 27, 2014
  Last Verified: February 2014