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Outcome Measures

Primary Outcomes (2)

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.
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.
Change from baseline SRI or SRT score at 2 weeks

Secondary Outcomes (1)

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

Study Arms (2)

Placebo

EXPERIMENTAL

Subjects in the placebo group received the equivalent amount of starch and lactose mixture capsules and administered with the same schedule.

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.

Dietary Supplement: PM011

Interventions

PM011Dietary supplement

Also known as: Nelumbinis Semen

PM011Placebo

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Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Study Design

Study Type

interventional

Phase

not applicable

Allocation

RANDOMIZED

Masking

DOUBLE

Who Masked

PARTICIPANT, INVESTIGATOR

Masking Details

Double-blind study : Participants and investigators do not know which treatment is placebo or treatment.

Purpose

TREATMENT

Intervention Model

PARALLEL

Model Details: Double blinded, randomized, placebo-controlled clinical study for evaluating anti-stress effects of Nelumbinis Semen

Sponsor Type

INDUSTRY

Responsible Party

SPONSOR

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (2)

Placebo

PM011

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (2)

Placebo

PM011

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record