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Calcium Dobesilate vs Flavonoids for the Treatment of Early Hemorrhoidal Disease

This study is currently recruiting participants.
Verified January 2017 by Dr. SamiUllah, Services Hospital, Lahore
Sponsor:
ClinicalTrials.gov Identifier:
NCT02782455
First Posted: May 25, 2016
Last Update Posted: January 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. SamiUllah, Services Hospital, Lahore
  Purpose
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.

Condition Intervention Phase
Hemorrhoids Drug: Flavonoids Drug: CDobi Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Calcium Dobesilate vs Flavonoids for the Treatment of Early Hemorrhoidal Disease a Randomised Triple Blind Controlled Trial

Resource links provided by NLM:


Further study details as provided by Dr. SamiUllah, Services Hospital, Lahore:

Primary Outcome Measures:
  • Frequency of occurrence of rectal bleeding after usage of drug [ Time Frame: 1 weeks ]
    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 [ Time Frame: 1 weeks ]
    Patients will under gone per rectal examination and proctoscopy to look for grades of hemorrhoids whether its has decreased or increased.


Estimated Enrollment: 100
Actual Study Start Date: December 2016
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CDobi
Calcium dobesylate is given in this group
Drug: CDobi
Calcium dobesylate is administered
Other Name: dobesilate
Active Comparator: Flavono
Flavonoids are given in this group
Drug: Flavonoids
Daflon is administered
Other Name: Daflon

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Grade I and Grade II hemorrhoids

Exclusion Criteria:

  • CLD
  • colorectal/ anorectal Malignancy
  • self medication
  • local Quack Hakeem medication
  • pregnancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02782455


Contacts
Contact: Usman Ismat Butt, MBBS, FCPS +92-342-4343806 usmanismatbutt@yahoo.com
Contact: Sami Ullah, MBBS,BSc +92-344-4000322 drsamiullahbhatti@gmail.com

Locations
Pakistan
Services Hospital Lahore Recruiting
Lahore, Punjab, Pakistan, 54000
Contact: Sami Ullah, MBBS    +92-344-4000322    drsamiullahbhatti@gmail.com   
Sponsors and Collaborators
Services Hospital, Lahore
Investigators
Study Director: Dr. Waris Farooka, MBBS, FCPS, FRCS, FACS Services Institute of Medical Sciences
  More Information

Responsible Party: Dr. SamiUllah, Postgraduate trainee, Services Hospital, Lahore
ClinicalTrials.gov Identifier: NCT02782455     History of Changes
Other Study ID Numbers: DD
First Submitted: March 10, 2016
First Posted: May 25, 2016
Last Update Posted: January 27, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Calcium, Dietary
Calcium Dobesilate
Bone Density Conservation Agents
Physiological Effects of Drugs
Hemostatics
Coagulants