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

NCT03973099 | Completed

• 1 other identifier: KCMC07OT066
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stress

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

PM011 DIETARY_SUPPLEMENT

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.

Also known as: Nelumbinis Semen

PM011; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VTBIO Co. LTD: lead

MeSH Terms

Interventions

Nelumbinis Semen

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
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: June 4, 2019
• Study Start: June 7, 2007
• Primary Completion: December 30, 2007
• Study Completion: December 30, 2007
• Last Updated: June 4, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share