HemorrhoidsPhase 4NCT01881282
A Comparative Efficacy and Safety Study of Compound Carraghenates Cream With Mayinglong Musk Hemorrhoid Ointment in the Treatment of Hemorrhoids
A Phase 4 study testing Carraghenates Cream and Mayinglong Musk Hemorrhoid Ointment in people with Hemorrhoids, run by Xian-Janssen Pharmaceutical Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Hemorrhoids
- What is being tested?
- Carraghenates Cream and Mayinglong Musk Hemorrhoid Ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteChina
- Study dates
- 14 Dec 2006to 9 Feb 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Hemorrhoids
- Being tested
- Carraghenates Cream, Mayinglong Musk Hemorrhoid Ointment
- Keywords
- Hemorrhoids, Carraghenates, Mayinglong Musk, Titanoreine
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carraghenates CreamDrug
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 OintmentDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Carraghenates Cream | Experimental | Not described Receives: Drug: Carraghenates Cream |
| Mayinglong Musk Hemorrhoid Ointment | Active comparator | Not described Receives: Drug: Mayinglong Musk Hemorrhoid Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1 up to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study start14 Dec 2006
- Primary completion9 Feb 2008
- Study completion9 Feb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhoidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xian-Janssen Pharmaceutical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Pharmaceutical Research and Development LLC Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01881282
- Sponsor's protocol ID
- CR002125
- Other IDs
- TITC-CHN-IIS-02
- Status last verified
- Jun 2026
- First submitted
- 14 Jun 2013
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01881282
- Acronym / sponsor ID
- CR002125
- Conditions
- Hemorrhoids
- Keywords
- Hemorrhoids, Carraghenates, Mayinglong Musk, Titanoreine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Xian-Janssen Pharmaceutical Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Dec 2006 (actual)
- Primary completion
- 9 Feb 2008 (actual)
- Study completion
- 9 Feb 2008 (actual)
- First posted
- 19 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carraghenates Cream | Experimental | Drug: Carraghenates Cream |
| Mayinglong Musk Hemorrhoid Ointment | Active comparator | Drug: Mayinglong Musk Hemorrhoid Ointment |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carraghenates CreamCarraghenates 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. | Drug | Carraghenates Cream |
| Mayinglong Musk Hemorrhoid OintmentMayinglong 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. | Drug | Mayinglong Musk Hemorrhoid Ointment |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
Related trials for Hemorrhoids
Not yet recruiting
Auricular Indwelling Needles Added to Diosmin/Hesperidin for Grade I-II Internal Hemorrhoids With Heat-Toxin Syndrome
Internal Haemorrhoids
Enrolling by invitation
Ultrasound-Guided Versus Landmark-Guided Pudendal Block for Post-Hemorrhoidectomy Pain
Hemorrhoids, Postoperative Pain
Not yet recruitingObservational study
Bleeding Reduction in Grade II-III Haemorrhoids Through Embolization Treatment
Hemorrhoid, Hemorrhoid Bleeding
Recruiting
Ligasure Versus Conventional Diathermy in Hemorrhoidectomy
Hemorrhoids
Enrolling by invitationObservational study
Case-Specific Health Care Professional Clinical Survey for Concerto Versa™ Detachable Coils
Arteriovenous Malformation, Gastrointestinal Bleed
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Pharmaceutical Research and Development LLC Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Carraghenates Cream and Mayinglong Musk Hemorrhoid Ointment in people with Hemorrhoids, run by Xian-Janssen Pharmaceutical Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Acting Time (time frame: Day 1 up to Day 7). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.