StressNCT03973099

Double Blinded, Randomized, Placebo-controlled Clinical Study for Nelumbinis Semen

A study testing PM011 in people with Stress, run by VTBIO Co. LTD.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Stress
What is being tested?: PM011
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: No sites listed yet
Study dates: 7 Jun 2007to 30 Dec 2007
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Volunteers were selected based on following meet conditions;Men and women, who have willingness and capacity to comply with the study protocol, are included if they were aged 18 to 65 years.
Volunteers, who can understand Korean and English alphabet are selected.
Volunteers, who can communicate with clinical trial performer fully, comply with the all tests and medical examinations performed by study protocol.
All volunteers or their protectors understand purpose of study fully and sign their names or seal.
Volunteers, who do not come under exclusion criteria are selected.
BDI score of Volunteers, who can be >= 5.

Volunteers were excluded if they are applied to following meet conditions; Volunteers with fasting glucose level over 126 mg/dl.
Volunteers with hypertension as having over 140 mmHg of systolic blood pressure or 90 mmHg of diastolic blood pressure.
Volunteers with blood thyroid stimulating hormone below 0.3 or over 4.0.
Men with hemoglobin below 13.0 g/dl and women with hemoglobin below 12.0 g/dl.
Volunteers with abnormality of liver function as having over 1.5 times of normal levels of ALT or AST.
Patients with infections in upper airways or chronic diseases.
Mental illness patients with such as alcoholism.

About this study

Official title: Double Blinded, Randomized, Placebo-controlled Clinical Study for Evaluating Anti-stress Effects of Nelumbinis Semen by 2 Week Administration

Read the detailed description

Nelumbinis Semen, has been widely used as treatment of post-menopause symptoms in women for hundreds of years in many Asian countries. This study examines whether PM011, standardized herbal medicine made from Nelumbinis Semen, treats stress in above 5 of BDI score of human subjects and discusses its potential as treatment for depressed patients. Subjects were divided into three groups, the placebo-treated group (n = 10), the PM011-2.4 g treated group (n = 11) and PM011-4.8 g treated group (n = 11) per day. Alpha/Beta ratio of electroencephalogram (EGG), Beck Depression Inventory (BDI) and Stress Response Inventory (SRI) were conducted in order to measure changes in stress before and after 2 weeks of PM011 treatment.

Conditions: Stress
Being tested: PM011

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PM011Dietary supplement
Also called Nelumbinis Semen
PM011 is a 400 mg hard gelatin capsule containing water extracts of Nelumbinis Semen. The sprayed-dry extract of the herbal medicine used was purchased from Sun Ten pharmaceutical company in Taiwan. Each participant received twelve capsules of PM011, which divided into 2.4 g treatment or 4.8 g treatment group or placebo daily for two weeks and was instructed to take six capsules after breakfast and six capsules after dinner. Subjects in the placebo group received the equivalent amount of starch and lactose mixture capsules and administered with the same schedule.

Study groups in NCT03973099
Study group	Role	What they receive
Placebo	Experimental	Subjects in the placebo group received the equivalent amount of starch and lactose mixture capsules and administered with the same schedule. Receives: Dietary Supplement: PM011
PM011	Experimental	PM011 is a 400 mg hard gelatin capsule containing water extracts of Nelumbinis Semen. The sprayed-dry extract of the herbal medicine used was purchased from Sun Ten pharmaceutical company in Taiwan. Each participant received twelve capsules of PM011, which divided into 2.4 g treatment or 4.8 g treatment group or placebo daily for two weeks and was instructed to take six capsules after breakfast and six capsules after dinner. Receives: Dietary Supplement: PM011

What is being measured

The primary outcome is the main question the study is designed to answer.

Beck Depression Inventory (BDI)
BDI is a 21 item, self rated inventory with each item rated with a set of four possible answer choices of increasing intensity.
Measured: Change from baseline BDI score at 2 weeks
Stress Response Inventory or Test (SRI or SRT)
SRI is highly reliable and valid, and that it is utilized as an effective measure of stress for research in stress-related fields in Korea. SRI is a total of 39 response items under the seven subscales. The seven subscales are divided into tension (A), aggression (B), somatization (C), anger (D), depression (E), fatigue (F), and frustration (G). When the test is scored, a value of 0 to 4 is assigned for each answer and then the total score is compared to a key to determine the stress's severity.
Measured: Change from baseline SRI or SRT score at 2 weeks

Secondary outcomes (1)

Alpha/beta ratio of electroencephalogram (EEG)
Electroencephalogram (EEG) is used to measure the brain waves. Each wave pattern is associated with different mood state and state of consciousness. Alpha is one of four basic brain waves (delta, theta, alpha and beta) which make up the EEG. Alpha is seen in wakefulness where there is relaxed and effortless alertness. Beta is seen in highly stressful situations, and where there is difficult mental concentration and focus. Therefore, high alpha and less beta waves have been used as indices of relaxation, arousal, anti-stress, and better concentration.
Measured: Change from baseline Alpha/beta ratio of electroencephalogram (EEG) at 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jun 200730 Dec 2007

First posted4 Jun 2019
Study start7 Jun 2007
Primary completion30 Dec 2007
Study completion30 Dec 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for StressStudies 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: Double blinded, randomized, placebo-controlled clinical study for evaluating anti-stress effects of Nelumbinis Semen
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03973099
Sponsor's protocol ID: KCMC07OT066
Status last verified: Jun 2019
First submitted: 29 May 2019
Last updated: 4 Jun 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Stress trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Double Blinded, Randomized, Placebo-controlled Clinical Study for Evaluating Anti-stress Effects of Nelumbinis Semen by 2 Week Administration
ClinicalTrials.gov ID: NCT03973099
Acronym / sponsor ID: KCMC07OT066
Conditions: Stress
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: VTBIO Co. LTDIndustry (pharma, biotech, devices)
Study start: 7 Jun 2007 (actual)
Primary completion: 30 Dec 2007 (actual)
Study completion: 30 Dec 2007 (actual)
First posted: 4 Jun 2019 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: Double blinded, randomized, placebo-controlled clinical study for evaluating anti-stress effects of Nelumbinis Semen

Arm	Type	Receives
Placebo	Experimental	Dietary Supplement: PM011Subjects in the placebo group received the equivalent amount of starch and lactose mixture capsules and administered with the same schedule.
PM011	Experimental	Dietary Supplement: PM011PM011 is a 400 mg hard gelatin capsule containing water extracts of Nelumbinis Semen. The sprayed-dry extract of the herbal medicine used was purchased from Sun Ten pharmaceutical company in Taiwan. Each participant received twelve capsules of PM011, which divided into 2.4 g treatment or 4.8 g treatment group or placebo daily for two weeks and was instructed to take six capsules after breakfast and six capsules after dinner.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

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
PM011Also: Nelumbinis SemenPM011 is a 400 mg hard gelatin capsule containing water extracts of Nelumbinis Semen. The sprayed-dry extract of the herbal medicine used was purchased from Sun Ten pharmaceutical company in Taiwan. Each participant received twelve capsules of PM011, which divided into 2.4 g treatment or 4.8 g treatment group or placebo daily for two weeks and was instructed to take six capsules after breakfast and six capsules after dinner. Subjects in the placebo group received the equivalent amount of starch and lactose mixture capsules and administered with the same schedule.	Dietary supplement	PM011, Placebo

Primary outcome

Beck Depression Inventory (BDI)
Time frame: Change from baseline BDI score at 2 weeks
BDI is a 21 item, self rated inventory with each item rated with a set of four possible answer choices of increasing intensity.
Stress Response Inventory or Test (SRI or SRT)
Time frame: Change from baseline SRI or SRT score at 2 weeks
SRI is highly reliable and valid, and that it is utilized as an effective measure of stress for research in stress-related fields in Korea. SRI is a total of 39 response items under the seven subscales. The seven subscales are divided into tension (A), aggression (B), somatization (C), anger (D), depression (E), fatigue (F), and frustration (G). When the test is scored, a value of 0 to 4 is assigned for each answer and then the total score is compared to a key to determine the stress's severity.

1 secondary outcome

Alpha/beta ratio of electroencephalogram (EEG)
Time frame: Change from baseline Alpha/beta ratio of electroencephalogram (EEG) at 2 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
Individual participant dataSharing planned: No

Related trials for Stress

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Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
RecruitingPhase 4
Effect of a Furosemide Stress Test-Guided Strategy on Liberation From Continuous Renal Replacement Therapy in Critically Ill Patients With Acute Kidney Injury
Acute Kidney Injury
Not yet recruiting
Mandala Coloring in Late Pregnancy
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Not yet recruitingObservational study
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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.

Questions about this trial

What is this clinical trial studying?

A study testing PM011 in people with Stress, run by VTBIO Co. LTD.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: finished, as of the sponsor's last update on 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Beck Depression Inventory (BDI) (time frame: Change from baseline BDI score at 2 weeks). 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?

On the ClinicalTrials.gov record for NCT03973099.

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 4 Jun 2019.