HemorrhoidsPhase 1/2NCT02301052
Evaluation of Allium Ampeloprasum Spp.Iranicum Cream Effect for the Management of Hemorrhoids Symptoms
A Phase 1/2 study testing Leek topical cream and Anti-hemorrhoid topical cream in people with Hemorrhoids, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial summary
Purpose of study is evaluation of Allium ampeloprasum Spp.Iranicum cream efficacy in management of symptomatic hemorrhoids in a double blind randomized placebo-control trial Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemorrhoids
- What is being tested?
- Leek topical cream and Anti-hemorrhoid topical cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteIran
- Study dates
- Sep 2014to Dec 2014
- Phase
- Phase 1/2
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants having symptomatic hemorrhoids(GRADE 1-4) without need to emergency operation according to physical examination
- 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 anal fissure or inflammatory bowel disease or history of gastrointestinal cancer
- Participants having hypersensitive predisposition or hypersensitive to Allium ampeloprasum or history of skin hypersensivity
- Female participants under pregnancy or during breastfeeding period
- Participants complicated by serious cardio cerebro vascular diseases, hepatic and renal diseases, diseases of hemopoietic system or neurologic disorders or ascitis g- history of steroid or anticoagulant drug consumption
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Vice-Chancellery of Research and Technology office, Shiraz University of Medical Sciences
Shiraz, Fars, 009871
Seyed Hamdollah Mosavat, MD, hamdi_88114@yahoo.com
About this study
Official title: Double Blind Randomized Placebo-control Trial of Allium Ampeloprasum Spp.Iranicum Cream Effect for the Management of Hemorrhoids Symptoms
Purpose of study is evaluation of Allium ampeloprasum Spp.Iranicum cream efficacy in management of symptomatic hemorrhoids in a double blind randomized placebo-control trial
Read the detailed description
Purpose of study: evaluation of Allium ampeloprasum Spp.Iranicum cream efficacy for the management of hemorrhoids study design:Double blind randomized placebo-control trial, uni-central Study population: Participants having symptomatic hemorrhoids attending Shiraz University of Medical Sciences clinics Inclusion criteria: Patients with symptomatic hemorrhoids(GRADE 1-4) without need to emergency operation according to physical examination Exclusion criteria: Participants having anal fissure or inflammatory bowel disease or history of gastrointestinal cancer Sample size: 75 patients (tree groups) Interventions: Topical Allium ampeloprasum cream/ placebo cream/anti-hemorrhoid cream Time period: 3 week Outcome measures: pain,itching, bleeding, defecate discomfort, total improvement, constipation
- Conditions
- Hemorrhoids
- Being tested
- Leek topical cream, placebo topical cream, Anti-hemorrhoid topical cream
- Keywords
- hemorrhoids, Allium Ampeloprasum, herbal medicine, traditional persian medicine
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leek topical creamDrug
Also called Allium Ampeloprasum Spp.Iranicum topical cream
Leek (Allium Ampeloprasum Spp.Iranicum) topical cream 2 cc twice daily for 3 weeks
placebo topical creamDrug
placebo topical cream 2 cc twice daily for 3 weeks
Anti-hemorrhoid topical creamDrug
Anti hemorrhoid topical cream 2 cc twice daily for 3 weeks(This cream consists of lidocaine (5% w/w), hydrocortisone acetate (7.5% w/w), aluminium sub-acetate (3.5% w/w), and zinc oxide (18% w/w). 30 g )
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | placebo topical cream 2 cc twice daily for 3 weeks Receives: Drug: placebo topical cream |
| Anti-hemorrhoid topical cream drug | Active comparator | Anti hemorrhoid topical cream as a standard drug 2 cc twice daily for 3 week Receives: Drug: Anti-hemorrhoid topical cream |
| Leek topical cream | Active comparator | Leek (Allium Ampeloprasum Spp.Iranicum) topical cream 2 cc twice daily for 3 weeks Receives: Drug: Leek topical cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain (visual analogue scale(0-10))
method of measurement: visual analogue scale(0-10)
Measured: 3 weeks
bleeding ( questionnaire)
method of measurement questionnaire:grade (0-4) that was defined as follow: 0=no symptom, 1= mild, 2=moderate, 3= severe, 4=very severe.
Measured: 3 weeks
itching ( questionnaire)
method of measurement questionnaire: grade (0-4) that was defined as follow: 0=no symptom, 1= mild, 2=moderate, 3= severe, 4=very severe.
Measured: 3 weeks
defecate discomfort (visual analogue scale(0-10)
method of measurement: visual analogue scale(0-10)
Measured: 3 weeks
total improvement (visual analogue scale(0-10)
method of measurement:visual analogue scale(0-10)
Measured: 3 weeks
Secondary outcomes (1)
constipation (questionnaire)
method of measurement: questionnaire
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study startSep 2014
- Primary completionNov 2014 (estimated)
- Study completionDec 2014 (estimated)
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leyla Ghahramani, Shiraz University of Medical Sciences
- Investigators
- Leyla Ghahramani, Assistant proffessor, Principal investigator, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02301052
- Sponsor's protocol ID
- CT-9377-7127
- Status last verified
- Nov 2014
- First submitted
- 20 Nov 2014
- Last updated
- 25 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Randomized Placebo-control Trial of Allium Ampeloprasum Spp.Iranicum Cream Effect for the Management of Hemorrhoids Symptoms
- ClinicalTrials.gov ID
- NCT02301052
- Acronym / sponsor ID
- CT-9377-7127
- Conditions
- Hemorrhoids
- Keywords
- hemorrhoids, Allium Ampeloprasum, herbal medicine, traditional persian medicine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 25 Nov 2014 (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.
Purpose of study is evaluation of Allium ampeloprasum Spp.Iranicum cream efficacy in management of symptomatic hemorrhoids in a double blind randomized placebo-control trial
Detailed description
Purpose of study: evaluation of Allium ampeloprasum Spp.Iranicum cream efficacy for the management of hemorrhoids study design:Double blind randomized placebo-control trial, uni-central Study population: Participants having symptomatic hemorrhoids attending Shiraz University of Medical Sciences clinics Inclusion criteria: Patients with symptomatic hemorrhoids(GRADE 1-4) without need to emergency operation according to physical examination Exclusion criteria: Participants having anal fissure or inflammatory bowel disease or history of gastrointestinal cancer Sample size: 75 patients (tree groups) Interventions: Topical Allium ampeloprasum cream/ placebo cream/anti-hemorrhoid cream Time period: 3 week Outcome measures: pain,itching, bleeding, defecate discomfort, total improvement, constipation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placebo topical creamplacebo topical cream 2 cc twice daily for 3 weeks |
| Anti-hemorrhoid topical cream drug | Active comparator | Drug: Anti-hemorrhoid topical creamAnti hemorrhoid topical cream as a standard drug 2 cc twice daily for 3 week |
| Leek topical cream | Active comparator | Drug: Leek topical creamLeek (Allium Ampeloprasum Spp.Iranicum) topical cream 2 cc twice daily for 3 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants having symptomatic hemorrhoids(GRADE 1-4) without need to emergency operation according to physical examination
- 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 (4 listed)
- Participants having anal fissure or inflammatory bowel disease or history of gastrointestinal cancer
- Participants having hypersensitive predisposition or hypersensitive to Allium ampeloprasum or history of skin hypersensivity
- Female participants under pregnancy or during breastfeeding period
- Participants complicated by serious cardio cerebro vascular diseases, hepatic and renal diseases, diseases of hemopoietic system or neurologic disorders or ascitis g- history of steroid or anticoagulant drug consumption
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 |
|---|---|---|
| Leek topical creamAlso: Allium Ampeloprasum Spp.Iranicum topical creamLeek (Allium Ampeloprasum Spp.Iranicum) topical cream 2 cc twice daily for 3 weeks | Drug | Leek topical cream |
| placebo topical creamplacebo topical cream 2 cc twice daily for 3 weeks | Drug | placebo |
| Anti-hemorrhoid topical creamAnti hemorrhoid topical cream 2 cc twice daily for 3 weeks(This cream consists of lidocaine (5% w/w), hydrocortisone acetate (7.5% w/w), aluminium sub-acetate (3.5% w/w), and zinc oxide (18% w/w). 30 g ) | Drug | Anti-hemorrhoid topical cream drug |
Primary outcome
pain (visual analogue scale(0-10))
Time frame: 3 weeks
method of measurement: visual analogue scale(0-10)
bleeding ( questionnaire)
Time frame: 3 weeks
method of measurement questionnaire:grade (0-4) that was defined as follow: 0=no symptom, 1= mild, 2=moderate, 3= severe, 4=very severe.
itching ( questionnaire)
Time frame: 3 weeks
method of measurement questionnaire: grade (0-4) that was defined as follow: 0=no symptom, 1= mild, 2=moderate, 3= severe, 4=very severe.
defecate discomfort (visual analogue scale(0-10)
Time frame: 3 weeks
method of measurement: visual analogue scale(0-10)
total improvement (visual analogue scale(0-10)
Time frame: 3 weeks
method of measurement:visual analogue scale(0-10)
1 secondary outcome
constipation (questionnaire)
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2014.
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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.
Leyla Ghahramani, Assistant proffessor principal investigator
Shiraz University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Leek topical cream and Anti-hemorrhoid topical cream in people with Hemorrhoids, run by Shiraz University of Medical Sciences at 1 site in Iran.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 25 Nov 2014. 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 Iran. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seyed Hamdollah Mosavat, MD (00987132351087, hamdi_88114@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain (visual analogue scale(0-10)) (time frame: 3 weeks). The study lists 5 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 25 Nov 2014.