A Comparative Efficacy and Safety Study of Compound Carraghenates Cream With Mayinglong Musk Hemorrhoid Ointment in the Treatment of Hemorrhoids
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|ClinicalTrials.gov Identifier: NCT01881282|
Recruitment Status : Completed
First Posted : June 19, 2013
Last Update Posted : February 28, 2014
|Condition or disease||Intervention/treatment||Phase|
|Hemorrhoids||Drug: Carraghenates Cream Drug: Mayinglong Musk Hemorrhoid Ointment||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||123 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Comparative Clinical Research on Therapeutic Effect and Safety of Compound Carraghenates Cream Versus Mayinglong Musk Hemorrhoid Ointment in the Treatment of Hemorrhoids|
|Study Start Date :||December 2006|
|Actual Primary Completion Date :||February 2008|
|Actual Study Completion Date :||February 2008|
|Experimental: Carraghenates Cream||
Drug: Carraghenates Cream
Carraghenates cream will be administered 3-4 gram (g) each time (one sixth of a piece) through anal canal, twice a day (once in the morning and once in the evening); for consecutive 6 days.
|Active Comparator: Mayinglong Musk Hemorrhoid Ointment||
Drug: Mayinglong Musk Hemorrhoid Ointment
Mayinglong musk hemorrhoid ointment will be administered 2 g each time through anal canal, twice a day (once in the morning and once in the evening) for consecutive 6 days.
- 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: 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.
- Assessment of Other Symptoms and Signs Including Bleeding, Edema, Local Discomfort, and Prolapse [ Time Frame: Day 1 up to Day 7 ]Participants will assess these symptoms on a score range of 0 to 3 where 0=none for all symptoms and 3= "Blood jets while defecating, and the blood jetting stops after defecation" for bleeding, "serious edema" for edema, "severe" for local discomfort and "it is difficult or unable to return the prolapsed pile" for prolapse.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01881282
|Study Director:||Johnson & Johnson Pharmaceutical Research and Development LLC Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|