Title
Double Blinded, Randomized, Placebo-controlled Clinical Study for Nelumbinis Semen
Double Blinded, Randomized, Placebo-controlled Clinical Study for Evaluating Anti-stress Effects of Nelumbinis Semen by 2 Week Administration
Phase
N/ALead Sponsor
GMP BIO Co., LTD.Study Type
InterventionalStatus
Completed No Results PostedIndication/Condition
StressIntervention/Treatment
PM011Study Participants
46Nelumbinis 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.
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.
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.
Subjects in the placebo group received the equivalent amount of starch and lactose mixture capsules and administered with the same schedule.
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.
<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.
