NCT03016039

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2016

Completed
27 days until next milestone

Study Start

First participant enrolled

January 7, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 10, 2017

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

4.7 years

First QC Date

December 11, 2016

Last Update Submit

October 11, 2020

Conditions

Curcumin Use for Gynecological Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in the Levels of C reactive protein

    at recruitment and after two week and after one month

  • Change in the Levels of White blood cells

    at recruitment and after two week and after one month

Study Arms (2)

Dietary supplementation

EXPERIMENTAL

This group will receive Dietary supplementation

Dietary Supplement: Curcumin supplementation

conventional treatment

NO INTERVENTION

conventional Antibiotic treatment without curcumin supplementation

Interventions

Curcumin supplementationDIETARY_SUPPLEMENT

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

Dietary supplementation

Eligibility Criteria

Age18 Years - 52 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir hospital

Kfar Saba, Israel

RECRUITING

Central Study Contacts

Nissim ARBIB, MD

CONTACT

0097297471783Nisim.Arbib@clalit.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2016

First Posted

January 10, 2017

Study Start

January 7, 2017

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

October 14, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)