Hericium Erinaceus Mycelium and Probiotic of the Grape King Bio on Symptoms of Premenstrual Syndrome

Study Overview
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Brief Summary
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The purpose of this experiment is to evaluate the efficacy of supplemental health food Grape King Hericium erinaceus Mycelium Capsules and Grape King Probiotic Capsules in improving physical and psychological symptoms, blood oxidative stress and inflammation indicators in women with premenstrual syndrome.

Detailed Description
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This study was a randomized, double-blinded and placebo-controlled research. This study was approved by the Institutional Review Board of the Chung Shan Medical University Hospital and all Participants signed the written informed consent to participate in the study. Participants met the inclusion criteria, ie: age 20 45 yr and a regular menstrual cycle (21 35 days per cycle) were recruited through advertisements posted around the Chun Shan Medical university campus. In screening phase of this study, affective and one somatic symptom in before onset of menstruation in two consecutive cycles and was not affected by depression or anxiety disorder, she is examined by the Attending Physician of the Obstetrics and Gynecology Department to diagnosed a patient with premenstrual syndrome. In the intervention phase of this study, 105 eligible participant were randomly divided into intervention (Grape King Hericium erinaceus Mycelium Capsules and Grape King Probiotic Capsules) and control groups (n=35/group). Both subjects and researchers were blind to the treatment assignment until the statistical analysis was completed. All participants received two oral capsules containing Hericium erinaceus Mycelium, probiotics or placebo every day for the 3 months. The capsules of intervention supplementations and placebo provided by Grape King Biotechnology Inc in identical appearance and package to guarantee the blindness. Data collection A validated semi-quantitative Food Frequency Questionnaire was used to obtain daily nutritional values of participants. To assess the symptoms of PMS, all subjects need to fill out daily record of severity of problems on a daily basis in the 3 months of intervention period and 6 months after the intervention. In the 0, 1, 3 months of intervention, the anthropometric parameters and body composition were measured by using bioelectrical impedance analysis method ( MC-980 MA PLUS, TANITA BIA Technology). In the 0, 1, 3 months of intervention, venous blood samples were taken from all subjects for measuring the marks of oxidative stress and inflammation.

Official Title
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To Evaluate the Improvement Effect of Supplementing Hericium Erinaceus Mycelium Capsules and Grape King Probiotic Capsules of the Grape King Bio on Physiological and Psychological Symptoms of Premenstrual Syndrome

Conditions
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Premenstrual Syndrome

Intervention / Treatment
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* Dietary Supplement: Hericium Erinaceus Mycelium
* Dietary Supplement: Probiotic
* Dietary Supplement: control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged 20-45 The menstrual cycle is 21 35 days/time PMS diagnosed by an obstetrician Willing to sign the subject's consent form Exclusion Criteria: Those are with cancer, cardiovascular, kidney, liver, infectious and endocrine diseases, aw well as with depression and anxiety tendencies Those have a surgery in the last 6 months Those use of probiotics, estrogen and birth control pills Body mass index > 39 kg/m2, smoking, drinking Death of a close relative and other stressful events within the last 6 months

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: In the intervention phase of this study, 105 eligible participant were randomly divided into intervention (Grape King Hericium erinaceus Mycelium Capsules and Grape King Probiotic Capsules) and placebo groups (n=35/group). Both subjects and researchers were blind to the treatment assignment until the statistical analysis was completed.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hericium Erinaceus Mycelium<br>patients with premenstrual syndrome received supplementation of Hericium Erinaceus Mycelium capsules | Dietary Supplement: Hericium Erinaceus Mycelium<br>* participants received two oral capsules containing Hericium erinaceus Mycelium every day for the 3 months.<br>|
| Experimental: Probiotic<br>patients with premenstrual syndrome received supplementation of Probiotic capsules | Dietary Supplement: Probiotic<br>* participants received two oral capsules containing Probiotic powder every day for the 3 months.<br>|
| Placebo Comparator: control<br>patients with premenstrual syndrome received supplementation of placebo capsules | Dietary Supplement: control<br>* participants received two oral capsules containing control powder every day for the 3 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The differences from control of Daily record of severity of problems | This questionnaire of daily record of severity of problems were using to determine the severity of PMS including mood, physical and behavioral symptoms and characteristics. There are21 items grouped into 11 domains. Additional questions asked about quality of life and satisfaction of self-health. The levels of severity on this form are: 1- Not at all, 2- Minimal to Mild, 3-Moderate, 4- Severe. During each month of the intervention period and the 3rd menstrual cycles at the end of intervention, the differences of the total scores of menstrual cycles compared with the control group in each intervention groups were analyzed. | All eligible subjects recorded their symptoms by questionnaire of daily record of severity of problems at every day of 3 consecutive menstrual cycles during the intervention period and the 3rd menstrual cycles at the end of intervention. | 
| The changes from baseline of Daily record of severity of problems | This questionnaire of daily record of severity of problems were using to determine the severity of PMS including mood, physical and behavioral symptoms and characteristics. There are21 items grouped into 11 domains. Additional questions asked about quality of life and satisfaction of self-health. The levels of severity on this form are: 1- Not at all, 2- Minimal to Mild, 3-Moderate, 4- Severe. During each month of the intervention period and the 3rd menstrual cycles at the end of intervention, the changes of the total scores of menstrual cycles compared with the baseline in each groups were analyzed. | All eligible subjects recorded their symptoms by questionnaire of daily record of severity of problems at every day of 3 consecutive menstrual cycles during the intervention period and the 3rd menstrual cycles at the end of intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The differences from control of high-sensitivity C-reactive protein | The inflammation marker, high-sensitivity C-reactive protein (mg/L), in the blood of the subjects were measured. The different concentration of the high-sensitivity C-reactive protein at each time points of intervention groups compared with control group were analyzed. | In the 1st data of menstruation of the beginning, 1st and 3rd months of intervention, the blood of all eligible subjects were collected to measure the concentration of high-sensitivity C-reactive protein. | 
| The differences from baseline of high-sensitivity C-reactive protein | The inflammation marker, high-sensitivity C-reactive protein (mg/L), in the blood of the subjects were measured. The different concentration of the high-sensitivity C-reactive proteinat at the 1st and 3rd month compared with baseline in each group were analyzed. | In the 1st data of menstruation of the beginning, 1st and 3rd months of intervention, the blood of all eligible subjects were collected to measure the concentration of high-sensitivity C-reactive protein. | 
| The differences from control of high-sensitivity interleukin-6 | The inflammation marker, interleukin-6 (pg/mL), in the blood of the subjects were measured. The different concentration of the interleukin-6 at each time points of intervention groups compared with control group were analyzed. | In the 1st data of menstruation of the beginning, 1st and 3rd months of intervention, the blood of all eligible subjects were collected to measure the concentration of interleukin-6. | 
| The differences from baseline of high-sensitivity interleukin-6 | The inflammation marker, interleukin-6 (pg/mL), in the blood of the subjects were measured. The different concentration of the interleukin-6 at the 1st and 3rd month compared with baseline in each group were analyzed. | In the 1st data of menstruation of the beginning, 1st and 3rd months of intervention, the blood of all eligible subjects were collected to measure the concentration of interleukin-6. | 
| The differences from control of high-sensitivity interleukin-1 | The inflammation marker, interleukin-1 (pg/mL), in the blood of the subjects were measured. The different concentration of the interleukin-1 at each time points of intervention groups compared with control group were analyzed. | In the 1st data of menstruation of the beginning, 1st and 3rd months of intervention, the blood of all eligible subjects were collected to measure the concentration of interleukin-1. | 
| The differences from baseline of high-sensitivity interleukin-1 | The inflammation marker, interleukin-1 (pg/mL), in the blood of the subjects were measured. The different concentration of the interleukin-1 at the 1st and 3rd month compared with baseline in each group were analyzed. | In the 1st data of menstruation of the beginning, 1st and 3rd months of intervention, the blood of all eligible subjects were collected to measure the concentration of interleukin-1. | 
| The differences from control of high-sensitivity TNF-a | The inflammation marker, TNF-a (pg/mL), in the blood of the subjects were measured. The different concentration of the TNF-a at each time points of intervention groups compared with control group were analyzed. | In the 1st data of menstruation of the beginning, 1st and 3rd months of intervention, the blood of all eligible subjects were collected to measure the concentration of TNF-a. | 
| The differences from baseline of high-sensitivity TNF-a | The inflammation marker, TNF-a (pg/mL), in the blood of the subjects were measured. The different concentration of the TNF-a at the 1st and 3rd month compared with baseline in each group were analyzed. | In the 1st data of menstruation of the beginning, 1st and 3rd months of intervention, the blood of all eligible subjects were collected to measure the concentration of TNF-a. | 
| The differences from control of total antioxidant capacity | The oxidative stress index, total antioxidant capacity (μmol/L), in the blood of the subjects were measured. The different concentration of the total antioxidant capacity at each time points of intervention groups compared with control group were analyzed. | In the 1st data of menstruation of the beginning, 1st and 3rd months of intervention, the blood of all eligible subjects were collected to measure the concentration of total antioxidant capacity. | 
| The differences from baseline of total antioxidant capacity | The oxidative stress index, total antioxidant capacity (μmol/L), in the blood of the subjects were measured. The different concentration of the total antioxidant capacity at the 1st and 3rd month compared with baseline in each group were analyzed. | In the 1st data of menstruation of the beginning, 1st and 3rd months of intervention, the blood of all eligible subjects were collected to measure the concentration of total antioxidant capacity. | 
| The differences from control of malondialdehyde | The oxidative stress index, malondialdehyde (nmol/mL), in the blood of the subjects were measured. The different concentration of the total antioxidant capacity at each time points of intervention groups compared with control group were analyzed. | In the 1st data of menstruation of the beginning, 1st and 3rd months of intervention, the blood of all eligible subjects were collected to measure the concentration of malondialdehyde. | 
| The differences from baseline of malondialdehyde | The oxidative stress index, malondialdehyde (nmol/mL), in the blood of the subjects were measured. The different concentration of the total antioxidant capacity at the 1st and 3rd month compared with baseline in each group were analyzed. | In the 1st data of menstruation of the beginning, 1st and 3rd months of intervention, the blood of all eligible subjects were collected to measure the concentration of malondialdehyde. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Premenstrual Syndrome, Hericium Erinaceus mycelium, probiotic