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NCT02782455 Clinical Trial

Calcium Dobesilate vs Flavonoids for the Treatment of Early Hemorrhoidal Disease

Hemorrhoids Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02782455
Other study ID # DD
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date December 1, 2016
Est. completion date November 30, 2018

Study information
Verified date December 2018
Source Services Hospital, Lahore
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 of early haemorrhoidal disease.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date November 30, 2018
Est. primary completion date November 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 13 Years to 80 Years
Eligibility Inclusion Criteria:

- Grade I and Grade II hemorrhoids

Exclusion Criteria:

- CLD

- colorectal/ anorectal Malignancy

- self medication

- local Quack Hakeem medication

- pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Flavonoids
Daflon is administered
• CDobi
Calcium dobesylate is administered

Locations
Country Name City State
Pakistan Services Hospital Lahore Lahore Punjab

Sponsors (1)
Lead Sponsor Collaborator
Services Hospital, Lahore

Country where clinical trial is conducted

Pakistan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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