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Calcium Dobesilate vs Flavonoids for the Treatment of Early Hemorrhoidal Disease

Primary Purpose

Hemorrhoids

Status

Completed

Phase

Phase 4

Locations

Pakistan

Study Type

Interventional

Intervention

Flavonoids

CDobi

About this trial

This is an interventional treatment trial for Hemorrhoids

Eligibility Criteria

13 Years - 80 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Grade I and Grade II hemorrhoids

Exclusion Criteria:

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

Sites / Locations

Services Hospital Lahore

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CDobi

Flavono

Arm Description

Calcium dobesylate is given in this group

Flavonoids are given in this group

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

regression of hemorrhoids

Patients will under gone per rectal examination and proctoscopy to look for grades of hemorrhoids whether its has decreased or increased.

Full Information

NCT ID

NCT02782455

First Posted

March 10, 2016

Last Updated

December 23, 2018

Sponsor

Services Hospital, Lahore

1. Study Identification

Unique Protocol Identification Number

NCT02782455

Brief Title

Calcium Dobesilate vs Flavonoids for the Treatment of Early Hemorrhoidal Disease

Official Title

Calcium Dobesilate vs Flavonoids for the Treatment of Early Hemorrhoidal Disease a Randomised Triple Blind Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

December 1, 2016 (Actual)

Primary Completion Date

November 30, 2018 (Actual)

Study Completion Date

November 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Services Hospital, Lahore

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemorrhoids

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CDobi

Arm Type

Experimental

Arm Description

Calcium dobesylate is given in this group

Arm Title

Flavono

Arm Type

Active Comparator

Arm Description

Flavonoids are given in this group

Intervention Type

Drug

Intervention Name(s)

Flavonoids

Other Intervention Name(s)

Daflon

Intervention Description

Daflon is administered

Intervention Type

Drug

Intervention Name(s)

CDobi

Other Intervention Name(s)

dobesilate

Intervention Description

Calcium dobesylate is administered

Primary Outcome Measure Information:

Title

Frequency of occurrence of rectal bleeding after usage of drug

Description

After the patients will be given the two drugs they will be followed for the frequency of occurrence of rectal bleeding till two weeks

Time Frame

1 weeks

Secondary Outcome Measure Information:

Title

regression of hemorrhoids

Description

Patients will under gone per rectal examination and proctoscopy to look for grades of hemorrhoids whether its has decreased or increased.

Time Frame

1 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Grade I and Grade II hemorrhoids Exclusion Criteria: CLD colorectal/ anorectal Malignancy self medication local Quack Hakeem medication pregnancy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

Services Institute of Medical Sciences

Official's Role

Study Director

Facility Information:

Facility Name

Services Hospital Lahore

City

Lahore

State/Province

Punjab

ZIP/Postal Code

54000

Country

Pakistan

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Calcium Dobesilate vs Flavonoids for the Treatment of Early Hemorrhoidal Disease

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