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

NCT05443477 | Unknown

• 2 other identifiers: CS2-20104BR-CT004
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Premenstrual Syndrome

Keywords

Premenstrual Syndrome; Hericium Erinaceus mycelium; probiotic

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• The differences from control of high-sensitivity C-reactive protein

  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

  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

  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

  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

  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.

Study Arms (3)

Hericium Erinaceus Mycelium

EXPERIMENTAL

patients with premenstrual syndrome received supplementation of Hericium Erinaceus Mycelium capsules

Dietary Supplement: Hericium Erinaceus Mycelium

Probiotic

EXPERIMENTAL

patients with premenstrual syndrome received supplementation of Probiotic capsules

Dietary Supplement: Probiotic

control

PLACEBO COMPARATOR

patients with premenstrual syndrome received supplementation of placebo capsules

Dietary Supplement: control

Interventions

Hericium Erinaceus Mycelium DIETARY_SUPPLEMENT

participants received two oral capsules containing Hericium erinaceus Mycelium every day for the 3 months.

Hericium Erinaceus Mycelium

Probiotic DIETARY_SUPPLEMENT

participants received two oral capsules containing Probiotic powder every day for the 3 months.

Probiotic

control DIETARY_SUPPLEMENT

participants received two oral capsules containing control powder every day for the 3 months.

control

Eligibility Criteria

• Age: 20 Years - 45 Years
• Gender Eligibility Details: women who are menstruating
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chung Shan Medical University: lead

Study Sites (1)

Kai-Li Liu

Taichung, Taiwan

Location

Related Publications (5)

• Duvan CI, Cumaoglu A, Turhan NO, Karasu C, Kafali H. Oxidant/antioxidant status in premenstrual syndrome. Arch Gynecol Obstet. 2011 Feb;283(2):299-304. doi: 10.1007/s00404-009-1347-y. Epub 2010 Jan 19.

  PMID: 20084389 RESULT

• Danis P, Drew A, Lingow S, Kurz S. Evidence-based tools for premenstrual disorders. J Fam Pract. 2020 Jan/Feb;69(1):E9-E17. No abstract available.

  PMID: 32017837 RESULT

• Endicott J, Nee J, Harrison W. Daily Record of Severity of Problems (DRSP): reliability and validity. Arch Womens Ment Health. 2006 Jan;9(1):41-9. doi: 10.1007/s00737-005-0103-y. Epub 2005 Sep 20.

  PMID: 16172836 RESULT

• Sharifi-Rad J, Rodrigues CF, Stojanovic-Radic Z, Dimitrijevic M, Aleksic A, Neffe-Skocinska K, Zielinska D, Kolozyn-Krajewska D, Salehi B, Milton Prabu S, Schutz F, Docea AO, Martins N, Calina D. Probiotics: Versatile Bioactive Components in Promoting Human Health. Medicina (Kaunas). 2020 Aug 27;56(9):433. doi: 10.3390/medicina56090433.

  PMID: 32867260 RESULT

• Nagano M, Shimizu K, Kondo R, Hayashi C, Sato D, Kitagawa K, Ohnuki K. Reduction of depression and anxiety by 4 weeks Hericium erinaceus intake. Biomed Res. 2010 Aug;31(4):231-7. doi: 10.2220/biomedres.31.231.

  PMID: 20834180 RESULT

MeSH Terms

Conditions

Premenstrual Syndrome

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Kai-Li Liu, PhD

  Department of Nutrition, Chung Shan Medical University, Taichung, Taiwan

  STUDY CHAIR

• Man-Jung Hung, MD, PhD

  Department of Medicine, Chung Shan Medical University, Taichung, Taiwan

  PRINCIPAL INVESTIGATOR

• Yi-Chin Lin, PhD

  Department of Nutrition, Chung Shan Medical University, Taichung, Taiwan

  PRINCIPAL INVESTIGATOR

• Pey-Ling Shieh Shieh, PhD

  Department of Psychology, Chung Shan Medical University, Taichung, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both subjects and researchers were blind to the treatment assignment until the statistical analysis was completed. All the subjects were randomly divided into placebo group and two intervention groups (i.e. supplementation with Grape King Hericium erinaceus Mycelium Capsules and Grape King Probiotic Capsules) by using Excel to generate random numbers.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 12, 2022
• First Posted: July 5, 2022
• Study Start: June 8, 2021
• Primary Completion: January 7, 2023
• Study Completion: January 7, 2023
• Last Updated: July 5, 2022

Record last verified: 2022-06

Locations

TW (1)