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NCT Number: NCT01881282

A Comparative Efficacy and Safety Study of Compound Carraghenates Cream With 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.

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Key information

Conditions

Hemorrhoids Cardiovascular Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases Vascular Diseases

Age range

16 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beijing Hospital

Beijing, 100730, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carraghenates Cream

Drug

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

Drug

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Xian-Janssen Pharmaceutical Ltd.

Industry

Registry information

Official study title

A Comparative Clinical Research on Therapeutic Effect and Safety of Compound Carraghenates Cream Versus Mayinglong Musk Hemorrhoid Ointment in the Treatment of Hemorrhoids

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jun 19, 2013
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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