Premenstrual SyndromeNCT03881319
The Efficacy of Different Doses of Acupuncture in Dysmenorrhea
A study testing Conventional gynecologic treatment, Low dose acupuncture and High dose acupuncture in people with Premenstrual Syndrome and Dysmenorrhea, run by Taipei City Hospital at 1 site in Taiwan.
Trial summary
Subjects in this study included premenstrual syndrome and dysmenorrhea. Premenstrual syndrome (PMS) is the sum of a group of symptoms (including physical and psychological symptoms) that occurs during the luteal phase of the menstrual cycle. Read more about this study
- Who is it for?
- Ages 19 to 49 years, women only
- Conditions the study is for
- Premenstrual Syndrome, Dysmenorrhea
- What is being tested?
- Conventional gynecologic treatment, Low dose acupuncture and High dose acupuncture
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2018to 31 Dec 2019
- 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 19 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women within reproductive age (15 to 49 years)
- VAS≧4
- Women with a history of regular menstrual cycles (28days±7 days)
- Self-reported lower abdominal and pelvic, medial anterior thigh pain or low back pain associated with the onset of menses and lasting in 72 hours.
- 4.Symptoms: dysmenorrhagia, breast pain, dizziness, bloating, cramps, nausea, vomiting, diarrhea, headache, fatigue, etc.
Who cannot join
- Women with irregular menstrual cycles
- Women use of an intrauterine contraceptive device (IUCD/IUD)
- Women with uncontrolled neurological diseases
- Lactation, pregnant women, or those with plans to get pregnant in the coming half year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Study of Efficacy and Effect of Different Dose Acupuncture on Autonomic Nervous Activity and Quality of Life in Women With Dysmenorrhea
Subjects in this study included premenstrual syndrome and dysmenorrhea.
Premenstrual syndrome (PMS) is the sum of a group of symptoms (including physical and psychological symptoms) that occurs during the luteal phase of the menstrual cycle. Dysmenorrhea is a sort of period pelvic pain, caused by blood flow decrease abruptly and ischemia due to frequent contraction of the uterus.
Read more
In clinical practice, gynecologists apply analgesic such as Non-steroidal Anti- inflammatory Drugs (NSAIDs), and oral contraceptive pills (OCT) or progestin as conventional therapy for premenstrual syndrome and dysmenorrhea. As NSAIDs may cause gastrointestinal discomfort, dyspepsia while hormone therapy leads to other concerns; some women now adopt acupuncture as an alternative therapy for its safety. However, many parameters affect the efficacy of acupuncture, such as the sorts of acupoints (of which meridians) or the numbers of acupoints; and proper evidence-based medicine on this issue is few.
Therefore, in this study, we aim to evaluate 1. The different impact of acupuncture and conventional therapy in premenstrual syndrome and dysmenorrhea women ; 2. Will the character (of which meridians) or numbers of acupoints be affecting factors of efficacy in treating premenstrual syndrome and dysmenorrhea? 3. Shall there be any relationship between the acupuncture and autonomic nerve activity adjustment in premenstrual syndrome and dysmenorrhea? 4. Shall there be any relationship between the acupuncture and TCM syndrome adjustment in premenstrual syndrome and dysmenorrhea?
Read the detailed description
Subjects in this study included premenstrual syndrome and dysmenorrhea.
Premenstrual syndrome (PMS) is the sum of a group of symptoms (including physical and psychological symptoms) that occurs during the luteal phase of the menstrual cycle. Women who have such symptoms have been estimated as high as 75%; of which 3% to 8% are severe symptoms, called premenstrual dysphoric disorder (premenstrual dysphoric syndrome, PMDD). The two groups are very similar. Premenstrual syndrome is mostly for physical discomfort, while premenstrual dysphoric syndrome is for emotional problems, affecting women's sleep seriously.
Dysmenorrhea is a sort of period pelvic pain, caused by blood flow decrease abruptly and ischemia due to frequent contraction of the uterus. Many females afflicted with dysmenorrhea to different extents; some suffered from depression, reduced the quality of life; others even need to withdraw from work or school for incapable of daily activity. Thus, dysmenorrhea causes a lot of health burden and worth our attention. The prevalence of dysmenorrhea is up to 50 %. Generally speaking, primary dysmenorrhea is a menstrual pain in the absence of pelvic pathology while secondary dysmenorrhea is caused by organic dysfunction such as endometriosis, uterus malformation, cervix structure, pelvic inflammation, etc.
In clinical practice, gynecologists apply analgesic such as Non-steroidal Anti- inflammatory Drugs (NSAIDs), and oral contraceptive pills (OCT) or progestin as conventional therapy for premenstrual syndrome and dysmenorrhea. As NSAIDs may cause gastrointestinal discomfort, dyspepsia while hormone therapy leads to other concerns; some women now adopt acupuncture as an alternative therapy for its safety. However, many parameters affect the efficacy of acupuncture, such as the sorts of acupoints (of which meridians) or the numbers of acupoints; and proper evidence-based medicine on this issue is few. According to the theory of Traditional Chinese Medicine, acupuncture regulates meridians' energy and coordinates yin/yang while the western medicine reveals that the mechanism of pain-control of acupuncture is relevant to the theory of neurophysiology and some neuropeptide releasing, such as endorphin. Additionally, in our previous study, we noted that the theory of yin/yang (meridian) is compatible with autonomic nerve theory. Since many symptoms women with Premenstrual Syndrome and dysmenorrhea suffered, such as poor sleep, anxiety, convulsion of the uterine muscle, are related to autonomic nerve dysfunction, we are intrigued to know whether or not the effect of acupuncture relates to adjusting autonomic nerve system. Therefore, in this study, we aim to evaluate 1. The different impact of acupuncture and conventional therapy in premenstrual syndrome and dysmenorrhea women ; 2. Will the character (of which meridians) or numbers of acupoints be affecting factors of efficacy in treating premenstrual syndrome and dysmenorrhea? 3. Shall there be any relationship between the acupuncture and autonomic nerve activity adjustment in premenstrual syndrome and dysmenorrhea? 4. Shall there be any relationship between the acupuncture and TCM syndrome adjustment in premenstrual syndrome and dysmenorrhea? We expect through this multidisciplinary study; we can coordinate not only the different viewpoints of both Chinese and western medicine but also verify the compatibility of the theory of yin/yang and autonomic nerve (parasympathetic/sympathetic). We look forward the study can not only be a reference for further evidence-based research but also by reconciling different perspectives of Chinese and western medicine, we can, in turn, promote the cross-talk of Chinese and Western medicine in practical and academic aspects.
- Conditions
- Premenstrual Syndrome, Dysmenorrhea
- Being tested
- Conventional gynecologic treatment, Low dose acupuncture, High dose acupuncture
- Keywords
- Acupuncture, Premenstrual Syndrome, Dysmenorrhea, Autonomic nervous activity, TCM syndrome, Meridian
- Medical subject headings
- Premenstrual Syndrome, Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional gynecologic treatmentDrug
Also called NSAIDs or oral contraceptives treatment
Taking NSAIDs or oral contraceptives.NSAIDs include Ibuprofen, Naproxen, Diclofenac, and Piroxicam. Oral contraceptives include Yasmin.
Low dose acupunctureDevice
Six acupoints: Three Yin Intersection( SP6)、Grandfather Grandson(SP4)、 Sea of Blood(SP10) 、Sea of Qi(RN6)、Origin Pass(RN4) 、Inner Pass(PC6)
High dose acupunctureDevice
Twelve acupoints: Three Yin Intersection( SP6)、Grandfather Grandson(SP4)、 Sea of Blood(SP10) 、Sea of Qi(RN6)、Origin Pass(RN4) 、Middle Extremity(RN3)、Inner Pass(PC6) 、Supreme Rush(LR3) 、Joining Valley(LI4) 、Supreme Stream(KI3) 、Uterus(EX-CA1) 、Leg Three Miles(ST36)
| Study group | Role | What they receive |
|---|---|---|
| Conventional Gynecologic Treatment group | Active comparator | Taking NSAIDs or oral contraceptives.NSAIDs include Ibuprofen, Naproxen, Diclofenac, and Piroxicam. Oral contraceptives include Yasmin. Receives: Drug: Conventional gynecologic treatment |
| Low dose acupuncture group | Experimental | Acupuncture has fewer acupuncture points. Receives: Device: Low dose acupuncture |
| High dose acupuncture group | Experimental | Acupuncture has more acupuncture points. Receives: Device: High dose acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wang Qi Chinese Medicine Questionnaire
This questionnaire is used to survey TCM constitutions. Evaluate body constitution of each individual by score(Balanced Constitution, Qi-deficient Constitution, Yang-deficient Constitution, Yin-deficient Constitution, Phlegm-dampness Constitution, Damp-heat Constitution, Stagnant Blood Constitution, Stagnant Qi Constitution, and Inherited Special Constitution).
Measured: We will evaluate separately at baseline and the end of cycle 4 (each cycle is 30 days). Change from Baseline TCM constitutions at 4 cycles (each cycle is 30 days). Time Frame: baseline and 4 cycles (each cycle is 30 days)
Heart rate variation (HRV) test
HRV test include time domain analysis and frequency domain analysis.Time domain analysis includes SDNN, R-MSSD and pNN50. Frequency domain analysis includes LF, HF, LF/HF and total power.
Measured: We will evaluate separately at baseline and the end of cycle 4 (each cycle is 30 days). Change from Baseline HRV parameter at 4 cycles (each cycle is 30 days). Time Frame: baseline and 4 cycles (each cycle is 30 days)
Secondary outcomes (5)
Visual analogue scale(VAS) score
VAS is used to assess the extent of menstrual pain.
Measured: We will evaluate separately at baseline and the end of cycle 4 (each cycle is 30 days). Change from Baseline VAS score at 4 cycles (each cycle is 30 days). Time Frame: baseline and 4 cycles (each cycle is 30 days)
Verbal multidimensional scoring system (VMSS) assessment
VMSS is used to assess the severity of dysmenorrhea. The VMSS assessment ranges from zero, one, two and three grade for evaluating the working ability, the systemic symptoms and whether analgesia is required or not.
Grade 0 indicates that menstruation is not painful and daily activity is unaffected.
Grade 1 indicates that menstruation is painful but seldom inhibits normal activity; analgesics are seldom required; mild pain.
Grade 2 indicates that daily activity is affected; analgesics required and give sufficient relief so that absence from school is unusual; moderate pain.
Grade 3 indicates that activity clearly inhibited; poor effect of analgesics; vegetative symptoms (headache, fatigue, vomiting, and diarrhea); severe pain.
Measured: We will evaluate separately at baseline and the end of cycle 4 (each cycle is 30 days). Change from Baseline VMSS assessment at 4 cycles (each cycle is 30 days). Time Frame: baseline and 4 cycles (each cycle is 30 days)
SF-12 Health Survey
SF-12 health survey is a questionnaire used to assess the quality of life of individuals. It contains a total of 12 questions and can be aggregated into physiological facets and psychological facets to assess the physiological and mental health status of the subjects.
Measured: We will evaluate separately at baseline and the end of cycle 4 (each cycle is 30 days). Change from Baseline SF-12 Health Survey at 4 cycles (each cycle is 30 days). Time Frame: baseline and 4 cycles (each cycle is 30 days)
Blood test
Contain:estrogen, progesterone and prostaglandin
Measured: We will evaluate separately at baseline and the end of cycle 4 (each cycle is 30 days). Change from Baseline blood test at 4 cycles (each cycle is 30 days). Time Frame: baseline and 4 cycles (each cycle is 30 days)
Menstrual Distress Questionnaire(MDQ)
Contain: Pain；Concentration；Behavioral Change；Autonomic Reactions；Water Retention；Negative Affect
Measured: We will evaluate separately at baseline and the end of cycle 4 (each cycle is 30 days). Change from Baseline Menstrual Distress Questionnaire at 4 cycles (each cycle is 30 days). Time Frame: baseline and 4 cycles (each cycle is 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start1 Jun 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei City Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Tsai-Ju Chien, PhD degree, Principal investigator, Taipei City HospitalYi-Shuo Huang, B.S. degree, Study director, Taipei City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03881319
- Sponsor's protocol ID
- TCHIRB-10701111
- Status last verified
- Jul 2018
- First submitted
- 1 Nov 2018
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study will have a continuous plan.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Efficacy and Effect of Different Dose Acupuncture on Autonomic Nervous Activity and Quality of Life in Women With Dysmenorrhea
- ClinicalTrials.gov ID
- NCT03881319
- Acronym / sponsor ID
- TCHIRB-10701111
- Conditions
- Premenstrual Syndrome, Dysmenorrhea
- Keywords
- Acupuncture, Premenstrual Syndrome, Dysmenorrhea, Autonomic nervous activity, TCM syndrome, Meridian
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Taipei City HospitalOther government
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 19 Mar 2019 (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.
Subjects in this study included premenstrual syndrome and dysmenorrhea.
Premenstrual syndrome (PMS) is the sum of a group of symptoms (including physical and psychological symptoms) that occurs during the luteal phase of the menstrual cycle. Dysmenorrhea is a sort of period pelvic pain, caused by blood flow decrease abruptly and ischemia due to frequent contraction of the uterus.
In clinical practice, gynecologists apply analgesic such as Non-steroidal Anti- inflammatory Drugs (NSAIDs), and oral contraceptive pills (OCT) or progestin as conventional therapy for premenstrual syndrome and dysmenorrhea. As NSAIDs may cause gastrointestinal discomfort, dyspepsia while hormone therapy leads to other concerns; some women now adopt acupuncture as an alternative therapy for its safety. However, many parameters affect the efficacy of acupuncture, such as the sorts of acupoints (of which meridians) or the numbers of acupoints; and proper evidence-based medicine on this issue is few.
Therefore, in this study, we aim to evaluate 1. The different impact of acupuncture and conventional therapy in premenstrual syndrome and dysmenorrhea women ; 2. Will the character (of which meridians) or numbers of acupoints be affecting factors of efficacy in treating premenstrual syndrome and dysmenorrhea? 3. Shall there be any relationship between the acupuncture and autonomic nerve activity adjustment in premenstrual syndrome and dysmenorrhea? 4. Shall there be any relationship between the acupuncture and TCM syndrome adjustment in premenstrual syndrome and dysmenorrhea?
Detailed description
Subjects in this study included premenstrual syndrome and dysmenorrhea.
Premenstrual syndrome (PMS) is the sum of a group of symptoms (including physical and psychological symptoms) that occurs during the luteal phase of the menstrual cycle. Women who have such symptoms have been estimated as high as 75%; of which 3% to 8% are severe symptoms, called premenstrual dysphoric disorder (premenstrual dysphoric syndrome, PMDD). The two groups are very similar. Premenstrual syndrome is mostly for physical discomfort, while premenstrual dysphoric syndrome is for emotional problems, affecting women's sleep seriously.
Dysmenorrhea is a sort of period pelvic pain, caused by blood flow decrease abruptly and ischemia due to frequent contraction of the uterus. Many females afflicted with dysmenorrhea to different extents; some suffered from depression, reduced the quality of life; others even need to withdraw from work or school for incapable of daily activity. Thus, dysmenorrhea causes a lot of health burden and worth our attention. The prevalence of dysmenorrhea is up to 50 %. Generally speaking, primary dysmenorrhea is a menstrual pain in the absence of pelvic pathology while secondary dysmenorrhea is caused by organic dysfunction such as endometriosis, uterus malformation, cervix structure, pelvic inflammation, etc.
In clinical practice, gynecologists apply analgesic such as Non-steroidal Anti- inflammatory Drugs (NSAIDs), and oral contraceptive pills (OCT) or progestin as conventional therapy for premenstrual syndrome and dysmenorrhea. As NSAIDs may cause gastrointestinal discomfort, dyspepsia while hormone therapy leads to other concerns; some women now adopt acupuncture as an alternative therapy for its safety. However, many parameters affect the efficacy of acupuncture, such as the sorts of acupoints (of which meridians) or the numbers of acupoints; and proper evidence-based medicine on this issue is few. According to the theory of Traditional Chinese Medicine, acupuncture regulates meridians' energy and coordinates yin/yang while the western medicine reveals that the mechanism of pain-control of acupuncture is relevant to the theory of neurophysiology and some neuropeptide releasing, such as endorphin. Additionally, in our previous study, we noted that the theory of yin/yang (meridian) is compatible with autonomic nerve theory. Since many symptoms women with Premenstrual Syndrome and dysmenorrhea suffered, such as poor sleep, anxiety, convulsion of the uterine muscle, are related to autonomic nerve dysfunction, we are intrigued to know whether or not the effect of acupuncture relates to adjusting autonomic nerve system. Therefore, in this study, we aim to evaluate 1. The different impact of acupuncture and conventional therapy in premenstrual syndrome and dysmenorrhea women ; 2. Will the character (of which meridians) or numbers of acupoints be affecting factors of efficacy in treating premenstrual syndrome and dysmenorrhea? 3. Shall there be any relationship between the acupuncture and autonomic nerve activity adjustment in premenstrual syndrome and dysmenorrhea? 4. Shall there be any relationship between the acupuncture and TCM syndrome adjustment in premenstrual syndrome and dysmenorrhea? We expect through this multidisciplinary study; we can coordinate not only the different viewpoints of both Chinese and western medicine but also verify the compatibility of the theory of yin/yang and autonomic nerve (parasympathetic/sympathetic). We look forward the study can not only be a reference for further evidence-based research but also by reconciling different perspectives of Chinese and western medicine, we can, in turn, promote the cross-talk of Chinese and Western medicine in practical and academic aspects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional Gynecologic Treatment group | Active comparator | Drug: Conventional gynecologic treatmentTaking NSAIDs or oral contraceptives.NSAIDs include Ibuprofen, Naproxen, Diclofenac, and Piroxicam. Oral contraceptives include Yasmin. |
| Low dose acupuncture group | Experimental | Device: Low dose acupunctureAcupuncture has fewer acupuncture points. |
| High dose acupuncture group | Experimental | Device: High dose acupunctureAcupuncture has more acupuncture points. |
Who may qualify
- Ages
- 19 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women within reproductive age (15 to 49 years)
- VAS≧4
- Women with a history of regular menstrual cycles (28days±7 days)
- Self-reported lower abdominal and pelvic, medial anterior thigh pain or low back pain associated with the onset of menses and lasting in 72 hours.
- 4.Symptoms: dysmenorrhagia, breast pain, dizziness, bloating, cramps, nausea, vomiting, diarrhea, headache, fatigue, etc.
Key exclusion criteria (4 listed)
- Women with irregular menstrual cycles
- Women use of an intrauterine contraceptive device (IUCD/IUD)
- Women with uncontrolled neurological diseases
- Lactation, pregnant women, or those with plans to get pregnant in the coming half year
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 |
|---|---|---|
| Conventional gynecologic treatmentAlso: NSAIDs or oral contraceptives treatmentTaking NSAIDs or oral contraceptives.NSAIDs include Ibuprofen, Naproxen, Diclofenac, and Piroxicam. Oral contraceptives include Yasmin. | Drug | Conventional Gynecologic Treatment group |
| Low dose acupunctureSix acupoints: Three Yin Intersection( SP6)、Grandfather Grandson(SP4)、 Sea of Blood(SP10) 、Sea of Qi(RN6)、Origin Pass(RN4) 、Inner Pass(PC6) | Device | Low dose acupuncture group |
| High dose acupunctureTwelve acupoints: Three Yin Intersection( SP6)、Grandfather Grandson(SP4)、 Sea of Blood(SP10) 、Sea of Qi(RN6)、Origin Pass(RN4) 、Middle Extremity(RN3)、Inner Pass(PC6) 、Supreme Rush(LR3) 、Joining Valley(LI4) 、Supreme Stream(KI3) 、Uterus(EX-CA1) 、Leg Three Miles(ST36) | Device | High dose acupuncture group |
Primary outcome
Wang Qi Chinese Medicine Questionnaire
Time frame: We will evaluate separately at baseline and the end of cycle 4 (each cycle is 30 days). Change from Baseline TCM constitutions at 4 cycles (each cycle is 30 days). Time Frame: baseline and 4 cycles (each cycle is 30 days)
This questionnaire is used to survey TCM constitutions. Evaluate body constitution of each individual by score(Balanced Constitution, Qi-deficient Constitution, Yang-deficient Constitution, Yin-deficient Constitution, Phlegm-dampness Constitution, Damp-heat Constitution, Stagnant Blood Constitution, Stagnant Qi Constitution, and Inherited Special Constitution).
Heart rate variation (HRV) test
Time frame: We will evaluate separately at baseline and the end of cycle 4 (each cycle is 30 days). Change from Baseline HRV parameter at 4 cycles (each cycle is 30 days). Time Frame: baseline and 4 cycles (each cycle is 30 days)
HRV test include time domain analysis and frequency domain analysis.Time domain analysis includes SDNN, R-MSSD and pNN50. Frequency domain analysis includes LF, HF, LF/HF and total power.
5 secondary outcomes
Visual analogue scale(VAS) score
Time frame: We will evaluate separately at baseline and the end of cycle 4 (each cycle is 30 days). Change from Baseline VAS score at 4 cycles (each cycle is 30 days). Time Frame: baseline and 4 cycles (each cycle is 30 days)
Verbal multidimensional scoring system (VMSS) assessment
Time frame: We will evaluate separately at baseline and the end of cycle 4 (each cycle is 30 days). Change from Baseline VMSS assessment at 4 cycles (each cycle is 30 days). Time Frame: baseline and 4 cycles (each cycle is 30 days)
SF-12 Health Survey
Time frame: We will evaluate separately at baseline and the end of cycle 4 (each cycle is 30 days). Change from Baseline SF-12 Health Survey at 4 cycles (each cycle is 30 days). Time Frame: baseline and 4 cycles (each cycle is 30 days)
Blood test
Time frame: We will evaluate separately at baseline and the end of cycle 4 (each cycle is 30 days). Change from Baseline blood test at 4 cycles (each cycle is 30 days). Time Frame: baseline and 4 cycles (each cycle is 30 days)
Menstrual Distress Questionnaire(MDQ)
Time frame: We will evaluate separately at baseline and the end of cycle 4 (each cycle is 30 days). Change from Baseline Menstrual Distress Questionnaire at 4 cycles (each cycle is 30 days). Time Frame: baseline and 4 cycles (each cycle is 30 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Individual participant dataSharing planned: No. This study will have a continuous plan.
Related trials for Premenstrual Syndrome
Not yet recruitingPhase 1
MLS101 Study in PMDD
Premenstrual Dysphoric Disorder ( PMDD), PMDD
Not yet recruiting
Integrated Core Stability Exercises and Yoga Program on Premenstrual Syndrome
Premenstrual Syndrome
Enrolling by invitation
Transcutaneous Auricular Neurostimulation (tAN) for Premenstrual Dysphoric Disorder (PMDD) and Perimenopause
Perimenopause, PMDD
Recruiting
A Clinical Trial to Evaluate the Effects of the Kaia Relief - Cycle System on Premenstrual Symptom Severity, Menstrual Discomfort, and Overall Well-Being in Premenopausal Women.
Premenstrual Syndrome, Menstrual Discomfort
RecruitingObservational study
Occupational Physicians Facing Premenstrual Dysphoric Disorder: Knowledge, Perceptions and Practices in Occupational Health
Premenstrual Dysphoric Disorder (PMDD)
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.
Tsai-Ju Chien, PhD degree principal investigator
Taipei City Hospital
Yi-Shuo Huang, B.S. degree study director
Taipei City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional gynecologic treatment, Low dose acupuncture and High dose acupuncture in people with Premenstrual Syndrome and Dysmenorrhea, run by Taipei City Hospital 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 5 inclusion and 4 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 19 Mar 2019. 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. 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?
Wang Qi Chinese Medicine Questionnaire (time frame: We will evaluate separately at baseline and the end of cycle 4 (each cycle is 30 days). Change from Baseline TCM constitutions at 4 cycles (each cycle is 30 days). Time Frame: baseline and 4 cycles (each cycle is 30 days)). 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?
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 19 Mar 2019.