Calcium Dobesilate vs Flavonoids for the Treatment of Early Hemorrhoidal Disease

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

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.

Study Overview

• Status: Completed
• Conditions: Hemorrhoids
• Intervention / Treatment: Drug: CDobi; Drug: Flavonoids

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54000
      • Services Hospital Lahore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 78 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Grade I and Grade II hemorrhoids

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CDobi; Calcium dobesylate is given in this group	Drug: CDobi; Calcium dobesylate is administered; Other Names: dobesilate
Active Comparator: Flavono; Flavonoids are given in this group	Drug: Flavonoids; Daflon is administered; Other Names: Daflon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Services Hospital, Lahore
• Investigators: Study Director: Dr. Waris Farooka, MBBS, FCPS, FRCS, FACS, Services Institute of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): November 30, 2018
• Study Completion (Actual): November 30, 2018

Study Registration Dates

• First Submitted: March 10, 2016
• First Submitted That Met QC Criteria: May 20, 2016
• First Posted (Estimate): May 25, 2016

Study Record Updates

• Last Update Posted (Actual): December 26, 2018
• Last Update Submitted That Met QC Criteria: December 23, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Hemorrhoids
• Other Study ID Numbers: DD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No