Curcumin Supplementation for Gynecological Diseases

Curcumin Use for Gynecological Conditions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03016039
• Other study ID #: 0210-16-MMC
• Status: Recruiting
• Phase: N/A
• Start date: January 7, 2017
• Est. completion date: October 2021

Study information

• Verified date: October 2020
• Source: Meir Medical Center
• Contact: Nissim ARBIB, MD
• Phone: 0097297471783
• Email: Nisim.Arbib[@]clalit.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: October 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 52 Years

Eligibility

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.

Related Conditions & MeSH terms

• Curcumin Use for Gynecological Conditions

Intervention

Dietary Supplement:
• Curcumin supplementation
use of curcumin supplementation as an additive treatment to the conventional treatment

Locations

Country	Name	City	State
Israel	Meir hospital	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Levels of C reactive protein		at recruitment and after two week and after one month
Primary	Change in the Levels of White blood cells		at recruitment and after two week and after one month