Curcumin Use for Gynecological ConditionsNCT03016039
Curcumin Supplementation for Gynecological Diseases
A study testing Curcumin supplementation in people with Curcumin Use for Gynecological Conditions, run by Meir Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 52 years, women only
- Conditions the study is for
- Curcumin Use for Gynecological Conditions
- What is being tested?
- Curcumin supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteIsrael
- Study dates
- 7 Jan 2017to Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 52 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Meir hospital
Kfar Saba
Nissim Arbib, MD, 0097297471783, Nisim.Arbib@clalit.org.il
About this study
Official title: 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.
Read the 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.
- Being tested
- Curcumin supplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curcumin supplementationDietary supplement
use of curcumin supplementation as an additive treatment to the conventional treatment
| Study group | Role | What they receive |
|---|---|---|
| Dietary supplementation | Experimental | This group will receive Dietary supplementation Receives: Dietary Supplement: Curcumin supplementation |
| conventional treatment | No intervention | conventional Antibiotic treatment without curcumin supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Levels of C reactive protein
Measured: at recruitment and after two week and after one month
Change in the Levels of White blood cells
Measured: at recruitment and after two week and after one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study start7 Jan 2017
- Primary completionOct 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Curcumin Use for Gynecological ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03016039
- Sponsor's protocol ID
- 0210-16-MMC
- Status last verified
- Oct 2020
- First submitted
- 11 Dec 2016
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Curcumin Supplementation for Gynecological Diseases Including Pelvic Inflammatory Disease Endometritis, Endometriosis: A Pilot Study
- ClinicalTrials.gov ID
- NCT03016039
- Acronym / sponsor ID
- 0210-16-MMC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 7 Jan 2017
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 10 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary supplementation | Experimental | Dietary Supplement: Curcumin supplementationThis group will receive Dietary supplementation |
| conventional treatment | No intervention | –conventional Antibiotic treatment without curcumin supplementation |
Who may qualify
- Ages
- 18 to 52 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Curcumin supplementationuse of curcumin supplementation as an additive treatment to the conventional treatment | Dietary supplement | Dietary supplementation |
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Curcumin supplementation in people with Curcumin Use for Gynecological Conditions, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nissim ARBIB, MD (0097297471783, Nisim.Arbib@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Levels of C reactive protein (time frame: at recruitment and after two week and after one month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020; AzTrials last refreshed its copy on 29 Oct 2026.