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Diclofenac Potassium Alone Versus Diclofenac Potassium With Hyoscine-N-butyl Bromide (HBB in Endoscopy

NCT ID: NCT04125771

Last Updated: 2021-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-16

Study Completion Date

2020-10-01

Brief Summary

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Diclofenac is a proven, commonly prescribed nonsteroidal anti-inflammatory drug (NSAID) that has analgesic, anti-inflammatory, and antipyretic properties, and has been shown to be effective in treating a variety of acute and chronic pain and inflammatory conditions.

Detailed Description

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Diclofenac is a proven, commonly prescribed nonsteroidal anti-inflammatory drug (NSAID) that has analgesic, anti-inflammatory, and antipyretic properties, and has been shown to be effective in treating a variety of acute and chronic pain and inflammatory conditions.

. As with all NSAIDs, diclofenac exerts its action via inhibition of prostaglandin synthesis by inhibiting cyclooxygenase-1 (COX-1)

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Diclofenac + HBB

Women who will receive Diclofenac + HBB

Group Type OTHER

Diclofenac + HBB with hysteroscopy

Intervention Type DIAGNOSTIC_TEST

Giving Diclofenac + HBB with hysteroscopy

Diclofenav + placebo

Intervention Type DIAGNOSTIC_TEST

Giving Diclofenac + placebo with hysteroscopy

Diclofenav + placebo

Women who will receive Diclofenav + placebo

Group Type OTHER

Diclofenac + HBB with hysteroscopy

Intervention Type DIAGNOSTIC_TEST

Giving Diclofenac + HBB with hysteroscopy

Diclofenav + placebo

Intervention Type DIAGNOSTIC_TEST

Giving Diclofenac + placebo with hysteroscopy

Interventions

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Diclofenac + HBB with hysteroscopy

Giving Diclofenac + HBB with hysteroscopy

Intervention Type DIAGNOSTIC_TEST

Diclofenav + placebo

Giving Diclofenac + placebo with hysteroscopy

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 1\. Patients indicated for diagnostic hysteroscopy including infertility, bleeding, suspected intrauterine pathologies (eg polypi , septea) 2. Reproductive age 20 - 40yrs

Exclusion Criteria

* 1\. Menopausal and amenorrhic patients 2. Contraindication to office hysteroscopy such as:- pelvic inflammatory disease, marked cervical stenosis, pregnancy
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role collaborator

Aljazeera Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mahmoud Alalfy

Researcher , lecturer ,Obstetrics and Gynecology , National Research Centre

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mahmoud Alalfy, PhD

Role: STUDY_CHAIR

Algezeera hospitaland National Research Centre ,Egypt

Locations

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Algazeerah and Kasralainy hospital

Giza, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Diclofenac potassium

Identifier Type: -

Identifier Source: org_study_id