- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03016039
Curcumin Supplementation for Gynecological Diseases
Curcumin Supplementation for Gynecological Diseases Including Pelvic Inflammatory Disease Endometritis, Endometriosis: A Pilot Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nissim Arbib, MD
- Phone Number: 0097297471783
- Email: Nisim.Arbib@clalit.org.il
Study Locations
-
-
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Kfar Saba, Israel
- Recruiting
- Meir Hospital
-
Contact:
- Nissim Arbib, MD
- Phone Number: 0097297471783
- Email: Nisim.Arbib@clalit.org.il
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dietary supplementation
This group will receive Dietary supplementation
|
use of curcumin supplementation as an additive treatment to the conventional treatment
|
No Intervention: conventional treatment
conventional Antibiotic treatment without curcumin supplementation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in the Levels of C reactive protein
Time Frame: at recruitment and after two week and after one month
|
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
|
at recruitment and after two week and after one month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Curcumin
Other Study ID Numbers
- 0210-16-MMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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