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Curcumin Supplementation for Gynecological Diseases

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ClinicalTrials.gov Identifier: NCT03016039
Recruitment Status : Not yet recruiting
First Posted : January 10, 2017
Last Update Posted : January 12, 2017
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Curcumin Use for Gynecological Conditions Dietary Supplement: Curcumin supplementation Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Curcumin Supplementation for Gynecological Diseases Including Pelvic Inflammatory Disease Endometritis, Endometriosis: A Pilot Study
Study Start Date : January 2017
Estimated Primary Completion Date : October 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

Arm Intervention/treatment
Experimental: Dietary supplementation
This group will receive Dietary supplementation
Dietary Supplement: Curcumin supplementation
use of curcumin supplementation as an additive treatment to the conventional treatment

No Intervention: conventional treatment
conventional Antibiotic treatment without curcumin supplementation



Primary Outcome Measures :
  1. Change in the Levels of C reactive protein [ Time Frame: at recruitment and after two week and after one month ]
  2. Change in the Levels of White blood cells [ Time Frame: at recruitment and after two week and after one month ]


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Ages Eligible for Study:   18 Years to 52 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT03016039     History of Changes
Other Study ID Numbers: 0210-16-MMC
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Curcumin
Pelvic Inflammatory Disease
Genital Diseases, Female
Pelvic Infection
Infection
Adnexal Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action