Clinical Trial: Curcumin Supplementation for Gynecological Diseases

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Curcumin Supplementation for Gynecological Diseases Including Pelvic Inflammatory Disease Endometritis, Endometriosis: A Pilot Study

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.


Detailed Summary:

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.


Sponsor: Meir Medical Center

Current Primary Outcome:

  • Change in the Levels of C reactive protein [ Time Frame: at recruitment and after two week and after one month ]
  • Change in the Levels of White blood cells [ Time Frame: at recruitment and after two week and after one month ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Meir Medical Center

Dates:
Date Received: December 11, 2016
Date Started: January 2017
Date Completion:
Last Updated: January 11, 2017
Last Verified: October 2016