A Comparative Efficacy and Safety Study of Compound Carraghenates Cream With Mayinglong Musk Hemorrhoid Ointment in the Treatment of Hemorrhoids
A Comparative Clinical Research on Therapeutic Effect and Safety of Compound Carraghenates Cream Versus Mayinglong Musk Hemorrhoid Ointment in the Treatment of Hemorrhoids
2 other identifiers
interventional
123
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Dec 2006
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 14, 2013
CompletedFirst Posted
Study publicly available on registry
June 19, 2013
CompletedFebruary 28, 2014
February 1, 2014
1.2 years
June 14, 2013
February 27, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Pain Acting Time
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.
Day 1 up to Day 7
Pain Intensity Score at 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.
Day 4
Pain Intensity Score at 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.
Day 7
Daily Duration of Symptoms
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.
Day 1 up to Day 7
Frequency of Defecation
The daily frequency of defecation for the day prior to the visit and each day during the trial period will be assessed.
Day 1 up to Day 7
Participants' Satisfaction for the Treatment
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.
Day 7
Assessment of Other Symptoms and Signs Including Bleeding, Edema, Local Discomfort, and Prolapse
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.
Day 1 up to Day 7
Study Arms (2)
Carraghenates Cream
EXPERIMENTALMayinglong Musk Hemorrhoid Ointment
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- Participants who agree to participate in the current study
- Participants having painful hemorrhoids (swollen veins in the lower part of the rectum or anus \[external hemorrhoid, mixed hemorrhoid, etc.\])
- Participants who do not use drugs other than the study drug and the control drug to treat their hemorrhoids during the study period
You may not qualify if:
- Participants having other anorectal diseases , such as anal fistula , anal cleft , perianal abscess , and anorectal occupied lesions etc
- Participants having hypersensitive predisposition or hypersensitive to any of components of the study drugs
- Female participants under pregnancy or during breastfeeding period
- Participants who fail to accept the scheduled visits or are lost to the visits
- Participants complicated by serious cardio cerebro vascular diseases, hepatic and renal diseases, diseases of hemopoietic system or mental disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research and Development LLC Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2013
First Posted
June 19, 2013
Study Start
December 1, 2006
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
February 28, 2014
Record last verified: 2014-02