ImmunityNCT05324800
the Efficacy and Safety of Curcuma Longa Extract Mixture on Immune Enhancement
A study testing Curcuma Longa Extract Mixture in people with Immunity, run by Chonbuk National University Hospital at 1 site in South Korea.
Trial summary
This study was conducted to investigate the efficacy and safety of Curcuma longa extract mixture on immune enhancement Read more about this study
- Who is it for?
- Ages 19 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Immunity
- What is being tested?
- Curcuma Longa Extract Mixture
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Feb 2022to 27 May 2022
- 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 19 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult men and women over 19 and under 75 years
- After fully hearing and fully understanding this clinical trials, those who agree to voluntarily decide to participate and to comply with the notice
Who cannot join
- If screening shows that the white blood cell(WBC) is less than 3000/㎕ or more than 8000/㎕
- Those who received influenza vaccination within 2 months before first intake of intervention
- Those who have a body mass index(BMI) of less than 18.5 kg / m^2 or greater than 35 kg / m^2 at the screening
- Those who have a clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, liver biliary system, kidney and urinary system, neuropsychiatry, musculoskeletal system, inflammatory and hematologic and gastrointestinal disorders
- Those who take a medication or health function food that affects your promotion of immunity within 1 month prior to the screening
- Those who have received antipsychotic medication within 3 months before screening
Show all 14Show fewer
- Those who alcoholic or drug abuse suspected
- Those who participated in other clinical trials within 3 months before screening
- Laboratory test by show the following results
- Aspartate Transaminase(AST), Alanine Transaminase(ALT) > Reference range 3 times upper limit
- Serum Creatinine > 2.0 mg/dL
- Pregnancy or breast feeding
- Those who doesn't accept the implementation of appropriate contraception of a childbearing woman
- Principal Investigator judged inappropriate for participation in study because of Laboratory test result, etc.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Clinical Trial Center for Functional Foods Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 54907
About this study
Official title: This Study Was a 8 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Curcuma Longa Extract Mixture on Immune Enhancement
This study was conducted to investigate the efficacy and safety of Curcuma longa extract mixture on immune enhancement
Read the detailed description
This study was 8 weeks, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Curcuma longa extract mixture on immune enhancement
- Conditions
- Immunity
- Being tested
- Curcuma Longa Extract Mixture, placebo group
- Keywords
- Immunity, Curcuma Longa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curcuma Longa Extract MixtureDietary supplement
2 times a day, 2 capsule for 1 time, after breakfast/dinner meal, for 8 week
placebo groupDietary supplement
2 times a day, 2 capsule for 1 time, after breakfast/dinner meal, for 8 week
| Study group | Role | What they receive |
|---|---|---|
| Curcuma longa L. extract mixture group | Experimental | 2 times a day, 2 capsule for 1 time, after breakfast and dinner meal (1.6 g/day, Curcuma longa L. extract mixture 1 g/day) Receives: Dietary Supplement: Curcuma Longa Extract Mixture |
| placebo group | Placebo comparator | 2 times a day, 2 capsule for 1 time, after breakfast and dinner meal (1.6 g/day, Curcuma longa L. extract mixture 0 g/day) Receives: Dietary Supplement: placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Natural Killer cell activity
Natural Killer cell activity was measured in study baseline and 8 week, using A ratio of effector cell to target cell ratio of 2.5:1, 5:1, 10:1.
Natural Killer cell activity(%)
= (Experimental - Effector Spontaneous - Target Spontaneous) / (Target Maximum - Target Spontaneous) × 100
Measured: baseline and 8 weeks
Secondary outcomes (2)
Changes of Interleukin-2, Interleukin-12, Interferon-Gamma and Tumor necrosis factor-alpha
For blood Interleukin-2(pg/mL), Interleukin-12(pg/mL), Interferon-Gamma(pg/mL) and Tumor necrosis factor-alpha(pg/mL) analysis, collect 3 ml of blood in one serum separate tube for 5 ml, leave at room temperature for 30 minutes for clotting, after then centrifuge at 3000 rpm (or 2000 xg) for 10 minutes.
Measured: baseline and 8 weeks
Changes of Wisconsin Upper Respiratory Symptom Survey-21(WURSS-21)
The Wisconsin Upper Respiratory Symptom Survey-21 will investigate on the day of visit (1st, 2nd and 3rd visits).
The Wisconsin Upper Respiratory Symptom Survey-21 consists of seven stages, including individual symptoms, functional quality of life, and overall improvement. Find the total score of symptoms by obtaining the sum of symptom questions, and the total score of quality of life by obtaining the sum of life questions. Additionally, the sum of the total points of symptoms and quality of life is obtained.
- All items of symptom score rank on a seven-point scale(1=very mild and 7=severe), where a higher score means higher severity. The symptom score ranges from 0(Do not have this symptom) to 70.
- All items of quality of life score rank on a seven-point scale(1=very mildly and 7=severely), where a higher score means higher severity. The quality of life score ranges from 0(Not at all) to 63.
- Therefore, the total score ranges from 0 to 133.
Measured: baseline, 4 weeks and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start4 Feb 2022
- Primary completion27 Apr 2022 (estimated)
- Study completion27 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo-Wan Chae, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05324800
- Sponsor's protocol ID
- NJS-IE-CEM
- Status last verified
- Apr 2022
- First submitted
- 20 Mar 2022
- Last updated
- 12 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- This Study Was a 8 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Curcuma Longa Extract Mixture on Immune Enhancement
- ClinicalTrials.gov ID
- NCT05324800
- Acronym / sponsor ID
- NJS-IE-CEM
- Conditions
- Immunity
- Keywords
- Immunity, Curcuma Longa
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Study start
- 4 Feb 2022 (actual)
- Primary completion
- 27 Apr 2022 (estimated)
- Study completion
- 27 May 2022 (estimated)
- First posted
- 12 Apr 2022 (actual)
- 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.
This study was conducted to investigate the efficacy and safety of Curcuma longa extract mixture on immune enhancement
Detailed description
This study was 8 weeks, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Curcuma longa extract mixture on immune enhancement
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Curcuma longa L. extract mixture group | Experimental | Dietary Supplement: Curcuma Longa Extract Mixture2 times a day, 2 capsule for 1 time, after breakfast and dinner meal (1.6 g/day, Curcuma longa L. extract mixture 1 g/day) |
| placebo group | Placebo comparator | Dietary Supplement: placebo group2 times a day, 2 capsule for 1 time, after breakfast and dinner meal (1.6 g/day, Curcuma longa L. extract mixture 0 g/day) |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult men and women over 19 and under 75 years
- After fully hearing and fully understanding this clinical trials, those who agree to voluntarily decide to participate and to comply with the notice
Key exclusion criteria (14 listed)
- If screening shows that the white blood cell(WBC) is less than 3000/㎕ or more than 8000/㎕
- Those who received influenza vaccination within 2 months before first intake of intervention
- Those who have a body mass index(BMI) of less than 18.5 kg / m^2 or greater than 35 kg / m^2 at the screening
- Those who have a clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, liver biliary system, kidney and urinary system, neuropsychiatry, musculoskeletal system, inflammatory and hematologic and gastrointestinal disorders
- Those who take a medication or health function food that affects your promotion of immunity within 1 month prior to the screening
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 |
|---|---|---|
| Curcuma Longa Extract Mixture2 times a day, 2 capsule for 1 time, after breakfast/dinner meal, for 8 week | Dietary supplement | Curcuma longa L. extract mixture group |
| placebo group2 times a day, 2 capsule for 1 time, after breakfast/dinner meal, for 8 week | Dietary supplement | placebo group |
Primary outcome
Changes of Natural Killer cell activity
Time frame: baseline and 8 weeks
Natural Killer cell activity was measured in study baseline and 8 week, using A ratio of effector cell to target cell ratio of 2.5:1, 5:1, 10:1. Natural Killer cell activity(%) = (Experimental - Effector Spontaneous - Target Spontaneous) / (Target Maximum - Target Spontaneous) × 100
2 secondary outcomes
Changes of Interleukin-2, Interleukin-12, Interferon-Gamma and Tumor necrosis factor-alpha
Time frame: baseline and 8 weeks
Changes of Wisconsin Upper Respiratory Symptom Survey-21(WURSS-21)
Time frame: baseline, 4 weeks and 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Curcuma Longa Extract Mixture in people with Immunity, run by Chonbuk National University Hospital at 1 site in South Korea.
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 2 inclusion and 14 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 12 Apr 2022. 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 South Korea. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Natural Killer cell activity (time frame: baseline and 8 weeks). 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 12 Apr 2022.