A Comparative Efficacy and Safety Study of Compound Carraghenates Cream With Mayinglong Musk Hemorrhoid Ointment in the Treatment of Hemorrhoids
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
123 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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