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

Chung Shan Medical University

Status: Active, not recruiting

Conditions: Premenstrual Syndrome

Treatments: Dietary Supplement: Probiotic; Dietary Supplement: Hericium Erinaceus Mycelium; Dietary Supplement: control

Study type: Interventional

Funder types: Other

Identifiers

NCT05443477

CS2-20104

BR-CT004 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 105 estimated patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Women aged 20-45
2. The menstrual cycle is 21~35 days/time
3. PMS diagnosed by an obstetrician
4. Willing to sign the subject's consent form

Exclusion criteria

1. Those are with cancer, cardiovascular, kidney, liver, infectious and endocrine diseases, aw well as with depression and anxiety tendencies
2. Those have a surgery in the last 6 months
3. Those use of probiotics, estrogen and birth control pills
4. Body mass index > 39 kg/m2, smoking, drinking
5. Death of a close relative and other stressful events within the last 6 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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105 participants in 3 patient groups, including a placebo group

Hericium Erinaceus Mycelium

Experimental group

Description:

patients with premenstrual syndrome received supplementation of Hericium Erinaceus Mycelium capsules

Treatment:

Dietary Supplement: Hericium Erinaceus Mycelium

Probiotic

Experimental group

Description:

patients with premenstrual syndrome received supplementation of Probiotic capsules

Treatment:

Dietary Supplement: Probiotic

control

Placebo Comparator group

Description:

patients with premenstrual syndrome received supplementation of placebo capsules

Treatment:

Dietary Supplement: control