Calcium Dobesilate vs Flavonoids for the Treatment of Ear... | NCT02782455

Studies
Calcium Dobesilate vs Flavonoids for the Treatment of Early Hemorrhoidal Disease

NCT02782455

Sponsor

Services Hospital, Lahore

Status

Completed

Last Update Posted

Dec 26, 2018Actual

Enrollment

100Actual

Phase

Phase 4

Conditions

Hemorrhoids

Interventions

Flavonoids
CDobi

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2016Actual

Primary Completion Date

Nov 30, 2018Actual

Completion Date

Nov 30, 2018Actual

First Submitted Date

Mar 10, 2016

First Submission Date that Met QC Criteria

May 20, 2016

First Posted Date

May 25, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 23, 2018

Last Update Posted Date

Dec 26, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CDobi	Experimental	Calcium dobesylate is given in this group	Drug: CDobi
Flavono	Active Comparator	Flavonoids are given in this group	Drug: Flavonoids

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Flavonoids	Drug	Daflon is administered	Flavono	Daflon

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
regression of hemorrhoids	Patients will under gone per rectal examination and proctoscopy to look for grades of hemorrhoids whether its has decreased or increased.	1 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Grade I and Grade II hemorrhoids

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dr. Waris Farooka, MBBS, FCPS, FRCS, FACS	Services Institute of Medical Sciences	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Services Hospital Lahore		Lahore	Punjab Province	54000	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006484	Hemorrhoids

Ancestor Terms

ID	Term
D012002	Rectal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005419	Flavonoids
D004145	Diosmin

Ancestor Terms

ID	Term
D002867	Chromones
D001578	Benzopyrans
D011714	Pyrans
D006573	Heterocyclic Compounds, 1-Ring

Browse Leaves

Not provided

Browse Branches

Not provided