HemorrhoidsPhase 4NCT02782455
Calcium Dobesilate vs Flavonoids for the Treatment of Early Hemorrhoidal Disease
A Phase 4 study testing Flavonoids and CDobi in people with Hemorrhoids, run by Services Hospital, Lahore at 1 site in Pakistan.
Trial summary
Haemorrhoids are vascular cushions in the anal canal that help in the control of stool. When inflamed they become pathological and may present with protrusion and bleeding. A randomized, triple blind , controlled study will be conducted to compare the efficacy of calcium dobesilate against flavanoids in the management… Read more about this study
- Who is it for?
- Ages 13 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemorrhoids
- What is being tested?
- Flavonoids and CDobi
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2016to 30 Nov 2018
- 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 13 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Grade I and Grade II hemorrhoids
Who cannot join
- CLD
- colorectal/ anorectal Malignancy
- self medication
- local Quack Hakeem medication
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Calcium Dobesilate vs Flavonoids for the Treatment of Early Hemorrhoidal Disease a Randomised Triple Blind Controlled Trial
Haemorrhoids are vascular cushions in the anal canal that help in the control of stool. When inflamed they become pathological and may present with protrusion and bleeding. A randomized, triple blind , controlled study will be conducted to compare the efficacy of calcium dobesilate against flavanoids in the management of early haemorrhoidal disease.
- Conditions
- Hemorrhoids
- Being tested
- Flavonoids, CDobi
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlavonoidsDrug
Also called Daflon
Daflon is administered
CDobiDrug
Also called dobesilate
Calcium dobesylate is administered
| Study group | Role | What they receive |
|---|---|---|
| CDobi | Experimental | Calcium dobesylate is given in this group Receives: Drug: CDobi |
| Flavono | Active comparator | Flavonoids are given in this group Receives: Drug: Flavonoids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of occurrence of rectal bleeding after usage of drug
After the patients will be given the two drugs they will be followed for the frequency of occurrence of rectal bleeding till two weeks
Measured: 1 weeks
Secondary outcomes (1)
regression of hemorrhoids
Patients will under gone per rectal examination and proctoscopy to look for grades of hemorrhoids whether its has decreased or increased.
Measured: 1 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2016 (estimated)
- Study start1 Dec 2016
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Services Hospital, Lahore
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. SamiUllah, Services Hospital, Lahore
- Investigators
- Dr. Waris Farooka, MBBS, FCPS, FRCS, FACS, Study director, Services Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02782455
- Sponsor's protocol ID
- DD
- Status last verified
- Dec 2018
- First submitted
- 10 Mar 2016
- Last updated
- 26 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcium Dobesilate vs Flavonoids for the Treatment of Early Hemorrhoidal Disease a Randomised Triple Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT02782455
- Acronym / sponsor ID
- DD
- Conditions
- Hemorrhoids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Services Hospital, LahoreOther government
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 25 May 2016 (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.
Haemorrhoids are vascular cushions in the anal canal that help in the control of stool. When inflamed they become pathological and may present with protrusion and bleeding. A randomized, triple blind , controlled study will be conducted to compare the efficacy of calcium dobesilate against flavanoids in the management of early haemorrhoidal disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CDobi | Experimental | Drug: CDobiCalcium dobesylate is given in this group |
| Flavono | Active comparator | Drug: FlavonoidsFlavonoids are given in this group |
Who may qualify
- Ages
- 13 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Grade I and Grade II hemorrhoids
Key exclusion criteria (5 listed)
- CLD
- colorectal/ anorectal Malignancy
- self medication
- local Quack Hakeem medication
- pregnancy
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 |
|---|---|---|
| FlavonoidsAlso: DaflonDaflon is administered | Drug | Flavono |
| CDobiAlso: dobesilateCalcium dobesylate is administered | Drug | CDobi |
Primary outcome
Frequency of occurrence of rectal bleeding after usage of drug
Time frame: 1 weeks
After the patients will be given the two drugs they will be followed for the frequency of occurrence of rectal bleeding till two weeks
1 secondary outcome
regression of hemorrhoids
Time frame: 1 weeks
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 26 Dec 2018.
- Individual participant dataSharing planned: Undecided
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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.
Dr. Waris Farooka, MBBS, FCPS, FRCS, FACS study director
Services Institute 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 4 study testing Flavonoids and CDobi in people with Hemorrhoids, run by Services Hospital, Lahore at 1 site in Pakistan.
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 1 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 26 Dec 2018. 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 Pakistan. 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?
Frequency of occurrence of rectal bleeding after usage of drug (time frame: 1 weeks). 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 26 Dec 2018.