Clinical trial NCT01881282: A Comparative Efficacy and Safety Study of Compound Carraghenates Cream With Mayinglong Musk Hemorrhoid Ointment in the Treatment of Hemorrhoids
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hemorrhoids
Keywords: Hemorrhoids
Carraghenates
Mayinglong Musk
Titanoreine
Lead sponsor: Xian-Janssen Pharmaceutical Ltd.
Sponsor class: INDUSTRY
First posted: 2013-06-19
Enrollment: 123
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 description: 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.

Eligibility criteria: Inclusion Criteria:

* 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 did not use other topical drugs to treat their hemorrhoids a day before the inclusion
* Participants who do not use drugs other than the study drug and the control drug to treat their hemorrhoids during the study period

Exclusion Criteria:

* 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

Primary outcomes:
measure: Pain Acting Time
timeFrame: Day 1 up to Day 7
measure: Pain Intensity Score at Day 4
timeFrame: Day 4
measure: Pain Intensity Score at Day 7
timeFrame: Day 7
measure: Daily Duration of Symptoms
timeFrame: Day 1 up to Day 7
measure: Frequency of Defecation
timeFrame: Day 1 up to Day 7
measure: Participants' Satisfaction for the Treatment
timeFrame: Day 7
measure: Assessment of Other Symptoms and Signs Including Bleeding, Edema, Local Discomfort, and Prolapse
timeFrame: Day 1 up to Day 7
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research and Development LLC Clinical Trial
role: STUDY_DIRECTOR
References: