Premenstrual SyndromeNCT05443477
Hericium Erinaceus Mycelium and Probiotic of the Grape King Bio on Symptoms of Premenstrual Syndrome
A study testing Hericium Erinaceus Mycelium and Probiotic in people with Premenstrual Syndrome, run by Chung Shan Medical University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Premenstrual Syndrome
- What is being tested?
- Hericium Erinaceus Mycelium and Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Jun 2021to 7 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed 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.
- Conditions
- Premenstrual Syndrome
- Being tested
- Hericium Erinaceus Mycelium, Probiotic, control
- Keywords
- Premenstrual Syndrome, Hericium Erinaceus mycelium, probiotic
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hericium Erinaceus MyceliumDietary supplement
participants received two oral capsules containing Hericium erinaceus Mycelium every day for the 3 months.
ProbioticDietary supplement
participants received two oral capsules containing Probiotic powder every day for the 3 months.
controlDietary supplement
participants received two oral capsules containing control powder every day for the 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Hericium Erinaceus Mycelium | Experimental | patients with premenstrual syndrome received supplementation of Hericium Erinaceus Mycelium capsules Receives: Dietary Supplement: Hericium Erinaceus Mycelium |
| Probiotic | Experimental | patients with premenstrual syndrome received supplementation of Probiotic capsules Receives: Dietary Supplement: Probiotic |
| control | Placebo comparator | patients with premenstrual syndrome received supplementation of placebo capsules Receives: Dietary Supplement: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start8 Jun 2021
- Primary completion7 Jan 2023 (estimated)
- Study completion7 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Premenstrual SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kai-Li Liu, PhD, Study chair, Department of Nutrition, Chung Shan Medical University, Taichung, TaiwanMan-Jung Hung, MD, PhD, Principal investigator, Department of Medicine, Chung Shan Medical University, Taichung, TaiwanYi-Chin Lin, PhD, Principal investigator, Department of Nutrition, Chung Shan Medical University, Taichung, TaiwanPey-Ling Shieh Shieh, PhD, Principal investigator, Department of Psychology, Chung Shan Medical University, Taichung, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05443477
- Sponsor's protocol ID
- CS2-20104
- Other IDs
- BR-CT004
- Status last verified
- Jun 2022
- First submitted
- 12 Jun 2022
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 20084389Danis 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.
PubMed 32017837Endicott 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.
PubMed 16172836Sharifi-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.
PubMed 32867260Nagano 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.
PubMed 20834180
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05443477
- Acronym / sponsor ID
- CS2-20104
- Conditions
- Premenstrual Syndrome
- Keywords
- Premenstrual Syndrome, Hericium Erinaceus mycelium, probiotic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- 8 Jun 2021 (actual)
- Primary completion
- 7 Jan 2023 (estimated)
- Study completion
- 7 Jan 2023 (estimated)
- First posted
- 5 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Hericium Erinaceus Mycelium | Experimental | Dietary Supplement: Hericium Erinaceus Myceliumpatients with premenstrual syndrome received supplementation of Hericium Erinaceus Mycelium capsules |
| Probiotic | Experimental | Dietary Supplement: Probioticpatients with premenstrual syndrome received supplementation of Probiotic capsules |
| control | Placebo comparator | Dietary Supplement: controlpatients with premenstrual syndrome received supplementation of placebo capsules |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hericium Erinaceus Myceliumparticipants received two oral capsules containing Hericium erinaceus Mycelium every day for the 3 months. | Dietary supplement | Hericium Erinaceus Mycelium |
| Probioticparticipants received two oral capsules containing Probiotic powder every day for the 3 months. | Dietary supplement | Probiotic |
| controlparticipants received two oral capsules containing control powder every day for the 3 months. | Dietary supplement | control |
Primary outcome
The differences from control of Daily record of severity of problems
Time frame: 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.
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.
The changes from baseline of Daily record of severity of problems
Time frame: 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.
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.
12 secondary outcomes
The differences from control of high-sensitivity C-reactive protein
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
- Results publication: PubMed 20084389Duvan 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.
- Results publication: PubMed 32017837Danis 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.
- Results publication: PubMed 16172836Endicott 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.
- Results publication: PubMed 32867260Sharifi-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.
- Results publication: PubMed 20834180Nagano 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kai-Li Liu, PhD study chair
Department of Nutrition, Chung Shan Medical University, Taichung, Taiwan
Man-Jung Hung, MD, PhD principal investigator
Department of Medicine, Chung Shan Medical University, Taichung, Taiwan
Yi-Chin Lin, PhD principal investigator
Department of Nutrition, Chung Shan Medical University, Taichung, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hericium Erinaceus Mycelium and Probiotic in people with Premenstrual Syndrome, run by Chung Shan Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The differences from control of Daily record of severity of problems (time frame: 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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05443477, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2022.