Postmenopausal PeriodNCT03061799
Efficacy and Safety of HPC-03 for Postmenopausal Symptom
A study testing HPC-03 in people with Postmenopausal Period, run by Jae Hoon Lee at 1 site in South Korea.
Trial summary
In women, as the age increases, ovarian function is lost, resulting in the deficiency of female hormones, resulting in menopause, in which menstruation is permanently lost. The average age of menopause in Korean women is 49.7 years old, which is equivalent to 22.3% of the total female population. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Period
- What is being tested?
- HPC-03
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2017to Dec 2017
- 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 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women 40 to 60 years old who have passed one year or more since the last menstrual period
- Women with a kupperman index score of 20 or higher
- Women who have agreed to participate in this trial before the start of the clinical trial and who have written an informed consent
Who cannot join
- Women with a body mass index (BMI) greater than 30 kg / m2
- Women using hormone preparations such as female hormones or similar hormone preparations (plant extracts, etc.) within 3 months
- Women with a history of endometrial hyperplasia, uterine cancer, endometrial cancer, breast or breast disease, sex hormone related cancer
- A woman with a history of severe migraine within the past 1 year, diagnosed with thromboembolism, cerebrovascular disease, myocardial infarction, unstable angina, or coronary angioplasty
- Women with severe mental illnesses such as depression and anxiety disorder, or those currently taking psychotropic drugs such as antidepressants
- Women with irregular uterine bleeding after 1 year of menopause
Show all 17Show fewer
- Patients with uncontrolled hypertension (160 / 100mmHg or higher, after 10 minutes of clinical test subjects)
- Patients with diabetes whose blood sugar is not controlled (fasting glucose 180 mg / dL or diabetes mellitus within 3 months)
- Those with uncontrolled thyroid disease (those who are considered to be able to participate in this trial by the tester can participate)
- drug or alcohol abuser
- If ALT(Alanine transaminase ) or AST(Aspartate transaminase) exceeds 3 times the normal upper limit of the research institute
- If creatinine exceeds twice the upper limit of the normal level of research institute
- Mammography / PAP smear If a clinically significant abnormality (Breast imaging-reporting and data system: BI-RADS category 0 or 3 or more, PAP smear is not abnormal up to ASCUS:atypical cells of undetermined significance) is confirmed (BI-RADS Category 0, )
- If you have participated in another clinical trial within one month of the start of this trial or plan to participate in another clinical trial during the trial period
- If the tester judges that the test is inappropriate for this clinical trial
- Women using thyroid hormone preparations, clonidine, anticoagulants or antithrombotic agents (Warfarin, Clopidogrel, etc.) within 3 months
- Women who took medicines or health functional foods related to women's menopause within a month
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance hospital, Yonsei University College of Medicine
Seoul, 03722
Jae hoon Lee, M.D., +82-10-9985-4676, jhlee126@yuhs.ac
Jisun Yun, M.D., +82-10-2622-5664, grimoire@yuhs.ac
About this study
Official title: Efficacy and Safety of HPC-03(Extracts of Angelica Gigas Nakai, Cnidium Rhizome, and Cinnamon Bark) for Postmenopausal Symptom
In women, as the age increases, ovarian function is lost, resulting in the deficiency of female hormones, resulting in menopause, in which menstruation is permanently lost. The average age of menopause in Korean women is 49.7 years old, which is equivalent to 22.3% of the total female population. In addition, the increase in the number of women who experience early menopause due to environmental factors such as stress as a result of the increase in the number of women entering the society is also a major cause of the expansion of the market for menopausal women's health functional foods. Women's menopausal symptoms have been regarded as a natural process for everyone, but with the recent interest in health and the results of related studies, the perception that menopausal symptom management is necessary has spread.
In traditional medicine of far east asia, danggui (Angelica gigas Nakai), taeunggung (Cnidium Rhizome), and broilers (Cinnamon bark) have been commonly used for postmenopausal symptoms improvement. However, scientific evidence for these foods are lacking. Therefore, in this study the investigators tried to examine the efficacy and safety of extracts of angelica gigas nakai, cnidium rhizome, and cinnamon bark in postmenopausal symptoms. This study is designed as double-blinded placebo control study.
Read the detailed description
The results of preclinical efficacy evaluation of HPC-03 (Angelica gigas Nakai complex extract) obtained by mixing materials mentioned above showed that increase of serum estrogen level and increase of bone mineral density (BMD) of femur due to ALP(Alkaline phosphatase ) inhibition, bone related index (BALP,bone-specific alkaline phosphatase ; CTX- 1,C-terminal telopeptide-1 ; Osteocalcin).
Therefore, the investigators aimed to confirm the safety and efficacy of HPC-03 (a complex extract of Angelica gigas Nakai) which has been confirmed in preclinical studies, on the improvement of menopausal symptoms.
- Conditions
- Postmenopausal Period
- Being tested
- HPC-03, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPC-03Dietary supplement
Also called angelica gigas nakai, cnidium rhizome, and cinnamon bark
HPC-03 is extracts of danggui (angelica gigas nakai), taeunggung (cnidium rhizome), and broilers (cinnamon bark).
PlaceboDietary supplement
Placebo is constituted of crystalline cellulose(50.5%), corn starch(33.10%), caramel color(1.90%), anhydrous citric acid(1.25%), silicon dioxide(1.90%), carboxymethylcellulose calcium(6.25%), magnesium stearate(2.50%), and coater (3.10%).
| Study group | Role | What they receive |
|---|---|---|
| HPC-03 | Experimental | To experimental arm randomly assigned, HPC-03 will administrated twice a day , two capsules each time (total dose of HPC-03: 2g/day) for 12 weeks (84days).
*(HPC-03: extracts of angelica gigas nakai, cnidium rhizome, and cinnamon bark.) Receives: Dietary Supplement: HPC-03 |
| Placebo | Placebo comparator | To control arm randomly assigned, placebo will administrated twice a day , two capsules each time for 12 weeks (84days). Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Modified Kupperman Index score at 6 weeks and 12 weeks
Measured: At baseline, 6weeks and 12 weeks after administration of HPC-03 or placebo
Secondary outcomes (3)
endometrial thickness measured by transvaginal ultrasonography
Measured: At baseline and 12 weeks after administration of HPC-03
serum estradiol (E2)
Measured: At baseline and 12 weeks after administration of HPC-03 or placebo
serum FSH (Follicular stimulating hormone)
Follicular stimulating hormone
Measured: At baseline and 12 weeks after administration of HPC-03 or placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study startJan 2017
- Primary completionMay 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal PeriodStudies 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
- Model description
- This clinical trial will be conducted in parallel with the test group or the control group randomly assigned.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jae Hoon Lee
- Sponsor type
- University, hospital or other
- Collaborators
- Gachon University Gil Medical Center, Daejeon University
- Responsible party
- Sponsor-investigator, Jae Hoon Lee, Severance Hospital
- Investigators
- Seok Kyo Seo, M.D., Ph.D., Study director, Department of Obstetrics and Gynecology, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03061799
- Sponsor's protocol ID
- 4-2016-0680
- Status last verified
- Feb 2017
- First submitted
- 22 Jan 2017
- Last updated
- 23 Feb 2017
- Results posted
- No
- Individual data sharing
- No
Publications
Kim SY, Seo SK, Choi YM, Jeon YE, Lim KJ, Cho S, Choi YS, Lee BS. Effects of red ginseng supplementation on menopausal symptoms and cardiovascular risk factors in postmenopausal women: a double-blind randomized controlled trial. Menopause. 2012 Apr;19(4):461-6. doi: 10.1097/gme.0b013e3182325e4b.
PubMed 22027944
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of HPC-03(Extracts of Angelica Gigas Nakai, Cnidium Rhizome, and Cinnamon Bark) for Postmenopausal Symptom
- ClinicalTrials.gov ID
- NCT03061799
- Acronym / sponsor ID
- 4-2016-0680
- Conditions
- Postmenopausal Period
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Jae Hoon LeeUniversity, hospital or other
- Collaborators
- Gachon University Gil Medical Center, Daejeon University
- Study start
- Jan 2017 (actual)
- Primary completion
- May 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 23 Feb 2017 (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.
In women, as the age increases, ovarian function is lost, resulting in the deficiency of female hormones, resulting in menopause, in which menstruation is permanently lost. The average age of menopause in Korean women is 49.7 years old, which is equivalent to 22.3% of the total female population. In addition, the increase in the number of women who experience early menopause due to environmental factors such as stress as a result of the increase in the number of women entering the society is also a major cause of the expansion of the market for menopausal women's health functional foods. Women's menopausal symptoms have been regarded as a natural process for everyone, but with the recent interest in health and the results of related studies, the perception that menopausal symptom management is necessary has spread.
In traditional medicine of far east asia, danggui (Angelica gigas Nakai), taeunggung (Cnidium Rhizome), and broilers (Cinnamon bark) have been commonly used for postmenopausal symptoms improvement. However, scientific evidence for these foods are lacking. Therefore, in this study the investigators tried to examine the efficacy and safety of extracts of angelica gigas nakai, cnidium rhizome, and cinnamon bark in postmenopausal symptoms. This study is designed as double-blinded placebo control study.
Detailed description
The results of preclinical efficacy evaluation of HPC-03 (Angelica gigas Nakai complex extract) obtained by mixing materials mentioned above showed that increase of serum estrogen level and increase of bone mineral density (BMD) of femur due to ALP(Alkaline phosphatase ) inhibition, bone related index (BALP,bone-specific alkaline phosphatase ; CTX- 1,C-terminal telopeptide-1 ; Osteocalcin).
Therefore, the investigators aimed to confirm the safety and efficacy of HPC-03 (a complex extract of Angelica gigas Nakai) which has been confirmed in preclinical studies, on the improvement of menopausal symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This clinical trial will be conducted in parallel with the test group or the control group randomly assigned.
| Arm | Type | Receives |
|---|---|---|
| HPC-03 | Experimental | Dietary Supplement: HPC-03To experimental arm randomly assigned, HPC-03 will administrated twice a day , two capsules each time (total dose of HPC-03: 2g/day) for 12 weeks (84days). *(HPC-03: extracts of angelica gigas nakai, cnidium rhizome, and cinnamon bark.) |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboTo control arm randomly assigned, placebo will administrated twice a day , two capsules each time for 12 weeks (84days). |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women 40 to 60 years old who have passed one year or more since the last menstrual period
- Women with a kupperman index score of 20 or higher
- Women who have agreed to participate in this trial before the start of the clinical trial and who have written an informed consent
Key exclusion criteria (17 listed)
- Women with a body mass index (BMI) greater than 30 kg / m2
- Women using hormone preparations such as female hormones or similar hormone preparations (plant extracts, etc.) within 3 months
- Women with a history of endometrial hyperplasia, uterine cancer, endometrial cancer, breast or breast disease, sex hormone related cancer
- A woman with a history of severe migraine within the past 1 year, diagnosed with thromboembolism, cerebrovascular disease, myocardial infarction, unstable angina, or coronary angioplasty
- Women with severe mental illnesses such as depression and anxiety disorder, or those currently taking psychotropic drugs such as antidepressants
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 |
|---|---|---|
| HPC-03Also: angelica gigas nakai, cnidium rhizome, and cinnamon barkHPC-03 is extracts of danggui (angelica gigas nakai), taeunggung (cnidium rhizome), and broilers (cinnamon bark). | Dietary supplement | HPC-03 |
| PlaceboPlacebo is constituted of crystalline cellulose(50.5%), corn starch(33.10%), caramel color(1.90%), anhydrous citric acid(1.25%), silicon dioxide(1.90%), carboxymethylcellulose calcium(6.25%), magnesium stearate(2.50%), and coater (3.10%). | Dietary supplement | Placebo |
Primary outcome
Change from baseline Modified Kupperman Index score at 6 weeks and 12 weeks
Time frame: At baseline, 6weeks and 12 weeks after administration of HPC-03 or placebo
3 secondary outcomes
endometrial thickness measured by transvaginal ultrasonography
Time frame: At baseline and 12 weeks after administration of HPC-03
serum estradiol (E2)
Time frame: At baseline and 12 weeks after administration of HPC-03 or placebo
serum FSH (Follicular stimulating hormone)
Time frame: At baseline and 12 weeks after administration of HPC-03 or placebo
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Results publication: PubMed 22027944Kim SY, Seo SK, Choi YM, Jeon YE, Lim KJ, Cho S, Choi YS, Lee BS. Effects of red ginseng supplementation on menopausal symptoms and cardiovascular risk factors in postmenopausal women: a double-blind randomized controlled trial. Menopause. 2012 Apr;19(4):461-6. doi: 10.1097/gme.0b013e3182325e4b.
- Individual participant dataSharing planned: No
Related trials for Postmenopausal Period
Active, not recruiting
AI-Supported Mobile High-Impact and Strengthening Exercise Program in Postmenopausal Women With Low Bone Density
Osteopenia
Recruiting
Hop Extract Versus Soy Isoflavone Extract for Menopausal Symptoms (HOPES)
Menopause, Perimenopause
Not yet recruiting
The Role of Diet Quality in Sleep Among Women in Postmenopause
Post Menopausal Women
Not yet recruitingObservational study
Serum Estradiol and Endometrial Thickness After Bariatric Surgery in Postmenopausal Women With Obesity
Obesity, Morbid, Postmenopause
Not yet recruiting
Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
Frozen Shoulder, Adhesive Capsulitis
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.
Seok Kyo Seo, M.D., Ph.D. study director
Department of Obstetrics and Gynecology, Yonsei University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPC-03 in people with Postmenopausal Period, run by Jae Hoon Lee 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 3 inclusion and 17 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 23 Feb 2017. 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?
Contact Jae Hoon Lee, M.D. (+82-10-9985-4676, jhlee126@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Modified Kupperman Index score at 6 weeks and 12 weeks (time frame: At baseline, 6weeks and 12 weeks after administration of HPC-03 or placebo). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03061799, which also lists 1 linked publication.
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 23 Feb 2017.