Calcium Dobesilate vs Flavonoids for the Treatment of Early Hemorrhoidal Disease

NCT02782455 — Phase 4, Completed, 100 participants, Services Hospital, Lahore

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

Registry	NCT02782455
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	100 (Actual)
Sponsor	Services Hospital, Lahore (Other gov)
Conditions	Hemorrhoids
Interventions	Flavonoids, CDobi (Drug)
Dates	start 2016-12-01, primary completion 2018-11-30, completion 2018-11-30, first posted 2016-05-25, last updated 2018-12-26
Locations	1 site in Pakistan

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
CDobi	Experimental	Drug: CDobi	Calcium dobesylate is given in this group
Flavono	Active comparator	Drug: Flavonoids	Flavonoids are given in this group

Flavonoids (Drug), also known as Daflon: Daflon is administered
CDobi (Drug), also known as dobesilate: Calcium dobesylate is administered

+Outcome measures

Primary outcomes

Frequency of occurrence of rectal bleeding after usage of drug [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 outcomes

regression of hemorrhoids [1 weeks]: Patients will under gone per rectal examination and proctoscopy to look for grades of hemorrhoids whether its has decreased or increased.

+Eligibility

Sex: All, ages: 13 Years to 80 Years, accepts healthy volunteers

Inclusion Criteria:

* Grade I and Grade II hemorrhoids

Exclusion Criteria:

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

+Locations (1)

Facility	City	Country	Status
Services Hospital Lahore	Lahore, Punjab Province	Pakistan

+Investigators

Dr. Waris Farooka, MBBS, FCPS, FRCS, FACS, Study director, Services Institute of Medical Sciences