Clinical trial NCT03973099: Double Blinded, Randomized, Placebo-controlled Clinical Study for Nelumbinis Semen
Official title: Double Blinded, Randomized, Placebo-controlled Clinical Study for Evaluating Anti-stress Effects of Nelumbinis Semen by 2 Week Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Lead sponsor: VTBIO Co. LTD
Sponsor class: INDUSTRY
First posted: 2019-06-04
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blinded, randomized, placebo-controlled clinical study for evaluating anti-stress effects of Nelumbinis Semen
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: \<Inclusion Criteria\>

* 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.

\<Exclusion Criteria\>

* 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.

Primary outcomes:
measure: Beck Depression Inventory (BDI)
timeFrame: Change from baseline BDI score at 2 weeks
measure: Stress Response Inventory or Test (SRI or SRT)
timeFrame: Change from baseline SRI or SRT score at 2 weeks
Secondary outcomes:
measure: Alpha/beta ratio of electroencephalogram (EEG)
timeFrame: Change from baseline Alpha/beta ratio of electroencephalogram (EEG) at 2 weeks
Other outcomes:
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