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

Not Applicable

Completed

• Conditions: Stress
• Interventions: Dietary Supplement: PM011

• Registration Number: NCT03973099
• Lead Sponsor: VTBIO Co. LTD

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.

Study Timeline

• Study Start: 2007-06-07
• Primary Completion: 2007-12-30
• Study Completion: 2007-12-30
• Study First Submitted: 2019-05-29
• Status Verified: 2019-06
• Study First Submitted QC: 2019-06-02
• Last Update Submitted: 2019-06-02
• Study First Posted: 2019-06-04
• Last Update Posted: 2019-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	PM011	Subjects in the placebo group received the equivalent amount of starch and lactose mixture capsules and administered with the same schedule.
PM011	PM011	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.

Primary Outcome Measures

Name	Time	Method
Beck Depression Inventory (BDI)	Change from baseline BDI score at 2 weeks	BDI is a 21 item, self rated inventory with each item rated with a set of four possible answer choices of increasing intensity.
Stress Response Inventory or Test (SRI or SRT)	Change from baseline SRI or SRT score at 2 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Alpha/beta ratio of electroencephalogram (EEG)	Change from baseline Alpha/beta ratio of electroencephalogram (EEG) at 2 weeks	Electroencephalogram (EEG) is used to measure the brain waves. Each wave pattern is associated with different mood state and state of consciousness. Alpha is one of four basic brain waves (delta, theta, alpha and beta) which make up the EEG. Alpha is seen in wakefulness where there is relaxed and effortless alertness. Beta is seen in highly stressful situations, and where there is difficult mental concentration and focus. Therefore, high alpha and less beta waves have been used as indices of relaxation, arousal, anti-stress, and better concentration.