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Calcium Dobesilate vs Flavonoids for the Treatment of Early Hemorrhoidal Disease

NCT ID: NCT02782455

Last Updated: 2018-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2018-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hemorrhoids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CDobi

Calcium dobesylate is given in this group

Group Type EXPERIMENTAL

CDobi

Intervention Type DRUG

Calcium dobesylate is administered

Flavono

Flavonoids are given in this group

Group Type ACTIVE_COMPARATOR

Flavonoids

Intervention Type DRUG

Daflon is administered

Interventions

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Flavonoids

Daflon is administered

Intervention Type DRUG

CDobi

Calcium dobesylate is administered

Intervention Type DRUG

Other Intervention Names

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Daflon dobesilate

Eligibility Criteria

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Inclusion Criteria

* Grade I and Grade II hemorrhoids

Exclusion Criteria

* CLD
* colorectal/ anorectal Malignancy
* self medication
* local Quack Hakeem medication
* pregnancy
Minimum Eligible Age

13 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Services Hospital, Lahore

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr. SamiUllah

Postgraduate trainee

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: STUDY_DIRECTOR

Services Institute of Medical Sciences

Locations

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Services Hospital Lahore

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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DD

Identifier Type: -

Identifier Source: org_study_id