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

VT BIO

Status: Completed

Conditions: Stress

Treatments: Dietary Supplement: PM011

Study type: Interventional

Funder types: Industry

Identifiers

NCT03973099

KCMC07OT066

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 2 patient groups

Placebo

Experimental group

Description:

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

Treatment:

Dietary Supplement: PM011

PM011

Experimental group

Description:

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.

Treatment:

Dietary Supplement: PM011