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A Comparative Clinical Research on Therapeutic Effect and Safety of Compound Carraghenates Cream Versus Mayinglong Musk Hemorrhoid Ointment in the Treatment of Hemorrhoids
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.
Details
| Lead sponsor | Xian-Janssen Pharmaceutical Ltd. |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 123 |
| Start date | 2006-12 |
| Completion | 2008-02 |
Conditions
- Hemorrhoids
Interventions
- Carraghenates Cream
- Mayinglong Musk Hemorrhoid Ointment
Primary outcomes
- Pain Acting Time — 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 — 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 — 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 — 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 — 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 — Day 7
Participants' will assess for the treatment satisfaction on numeric rating scale (NRS) ranging from 1 to 5, where 1= Very unsatisfactory; 2= Unsatisfactory; 3=General; 4= Satisfactory; 5= Very satisfactory.