Curcumin Supplementation for Gynecological Diseases

NCT ID: NCT03016039

Last Updated: 2020-10-14

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-07

Study Completion Date

2021-10-31

Brief Summary

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To use curcumin supplementation as an additive treatment to induce clinical, biochemical response and remission in patients with suspected Pelvic inflammatory disease, Tubo ovarian abcess, Endometritis, wound infection.

Hypothesis: An addition of oral curcumin to highly suspected PID/Endometritis/Wound infection patients may augment clinical and biochemical response and accelerates the improvements of the sign symptoms and reported outcomes of those diseases.

Detailed Description

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Pelvic inflammatory disease (PID), Endometritis, Wound infection are infections of the female reproductive system. Although PID is a well known pathophysiology the diagnosis method I not well established and its true magnitude is unknown. Many women report that they have been treated for PID when they did not suffer from it and vice versa. Hence the main way to diagnose remains clinical and currently there is no well-established biochemical marker. In endometritis and wound infection the cause may be known but the pathogens involved in the disease formation vary as for this broad spectrum antibiotic is needed.

Aims: To use curcumin supplementation as an additive treatment to induce clinical, biochemical response and remission in patients with suspected PID, Tubo ovarian abcess, Endometritis, wound infection.

Hypothesis: An addition of oral curcumin to highly suspected PID/Endometritis/Wound infection patients may augment clinical and biochemical response and accelerates the improvements of the sign symptoms and reported outcomes of those diseases.

Rational: Curcumin treatment has been shown to safe and efficient in inflammatory states such as in mild-moderate Ulcerative colitis (UC), obesity, and type II diabetes mellitus when used as an add-on to conventional treatment.

In the gynecology and especially in the PID/Tubo ovarian abcess diseases the use of Curcumin as a supplement has never been studied.

In the future it is necessary to study the use of curcumin in different gynecological diseases (e.g Endometriosis/Premenstrual syndrome (PMS) and also in gynecology oncology) in which inflammatory and immune response are involve in the disease.

Conditions

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Curcumin Use for Gynecological Conditions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dietary supplementation

This group will receive Dietary supplementation

Group Type EXPERIMENTAL

Curcumin supplementation

Intervention Type DIETARY_SUPPLEMENT

use of curcumin supplementation as an additive treatment to the conventional treatment

conventional treatment

conventional Antibiotic treatment without curcumin supplementation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Curcumin supplementation

use of curcumin supplementation as an additive treatment to the conventional treatment

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Age above 18
* The patient was admitted with a diagnosis of Pelvic inflammatory disease / Tubo ovarian abcess, surgical wound infection, Endometritis
* No Antibiotic treatment was given prior to her recruitment for the study
* The women is not in menopause

Exclusion Criteria

* Age below 18 and above 52
* Antibiotic treatment was given prior to her recruitment for the study
* The women is in menopause
* Pregnant women. Known other inflammatory disease.
Minimum Eligible Age

18 Years

Maximum Eligible Age

52 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Meir hospital

Kfar Saba, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Nissim ARBIB, MD

Role: CONTACT

0097297471783

Facility Contacts

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Nissim Arbib, MD

Role: primary

0097297471783

Other Identifiers

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0210-16-MMC

Identifier Type: -

Identifier Source: org_study_id

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