NCT02782455

Brief 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 of early haemorrhoidal disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 25, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

December 26, 2018

Status Verified

December 1, 2018

Enrollment Period

2 years

First QC Date

March 10, 2016

Last Update Submit

December 23, 2018

Conditions

Hemorrhoids

Outcome Measures

Primary Outcomes (1)

  • 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

    1 weeks

Secondary Outcomes (1)

  • regression of hemorrhoids

    1 weeks

Study Arms (2)

CDobi

EXPERIMENTAL

Calcium dobesylate is given in this group

Drug: CDobi

Flavono

ACTIVE COMPARATOR

Flavonoids are given in this group

Drug: Flavonoids

Interventions

FlavonoidsDRUG

Daflon is administered

Also known as: Daflon
Flavono
CDobiDRUG

Calcium dobesylate is administered

Also known as: dobesilate
CDobi

Eligibility Criteria

Age13 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Grade I and Grade II hemorrhoids

You may not qualify if:

  • CLD
  • colorectal/ anorectal Malignancy
  • self medication
  • local Quack Hakeem medication
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Services Hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Hemorrhoids

Interventions

FlavonoidsDiosmin

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingFlavones

Study Officials

  • Dr. Waris Farooka, MBBS, FCPS, FRCS, FACS

    Services Institute of Medical Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postgraduate trainee

Study Record Dates

First Submitted

March 10, 2016

First Posted

May 25, 2016

Study Start

December 1, 2016

Primary Completion

November 30, 2018

Study Completion

November 30, 2018

Last Updated

December 26, 2018

Record last verified: 2018-12

Locations

PA(1)