Premenstrual SyndromeNCT04296422
Different Does of Acupuncture on Premenstrual Syndrome Efficacy Analysis
A study testing NSAIDs or oral contraceptives treatment, Low dose acupuncture and High dose acupuncture in people with Premenstrual Syndrome, run by Taipei City Hospital at 1 site in Taiwan.
Trial summary
The design of the study includes 3 groups for women with premenstrual syndrome, 1low dose acupuncture in the low-dose group, 2 high dose acupuncture in the high-dose group, and 3 the drug group (contraceptives) . Read more about this study
- Who is it for?
- Ages 19 to 49 years, women only
- Conditions the study is for
- Premenstrual Syndrome
- What is being tested?
- NSAIDs or oral contraceptives 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 Jan 2019to 18 Sep 2020
- 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
- 1.15 to 49 years 2.with a history of regular menstrual cycles (28days±7 days) 3.Symptoms：breast pain、dizziness、bloating、cramps、nausea、vomiting、 diarrhea、headache、 fatigue，etc
Who cannot join
- irregular menstrual cycles
- intrauterine contraceptive device (IUCD/IUD)
- 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: Evaluation of the Effect of Different Acupuncture Dose on Premenstrual Syndrome and the Relationship Between Premenstrual Syndrome and TCM Syndrome Complex
The design of the study includes 3 groups for women with premenstrual syndrome, 1low dose acupuncture in the low-dose group, 2 high dose acupuncture in the high-dose group, and 3 the drug group (contraceptives) . Serum marker change of PGE2, CA125, E2, and progesterone in enrolled patients will be measured before and after treatment, along with VAS and MDQ questionnaires. The treatment efficacy of different groups and the relationship between PMS and patients TCM syndrome pattern will also be recorded and estimated.
Read the detailed description
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 (premenstrualdysphoric syndrome, PMDD). The two groups are very similar. PMS is mostly for physical discomfort, while PMDD is for emotional problems, affecting women's sleep seriously.
Regarding the treatment of premenstrual syndrome (PMS), western medicine adopt oral contraceptive pills (OCP) as the first-line medication. However, the common side effects of OCP, such as headache, dizziness, nausea, vomiting, depression, breast pain and so on are also troublesome, In recent years, some women also use acupuncture as an adjunctive replacement therapy because of its safety and fewer side effects. Nevertheless, the factors affecting treatment effect of acupuncture and moxibustion. such as the selection of acupoint s ( of which meridians) or number(dose) of acupuncture ,etc., maight affect the efficacy, yet the relevant research on this issue is not enough. In traditional Chinese medicine theory, acupuncture and moxibustion regulate the energy of the meridians and adjust blood and qi, which in turn help the balance of yin and yang. Female menstrual cycle is a process of conversion between yin and yang in TCM theory. While in western medicine, it is regulated by the endocrine system.
- Conditions
- Premenstrual Syndrome
- Being tested
- NSAIDs or oral contraceptives treatment, Low dose acupuncture, High dose acupuncture
- Keywords
- Acupuncture, Premenstrual Syndrome, TCM syndrome
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NSAIDs or oral contraceptives treatmentDrug
Also called Taking NSAIDs or oral contraceptives.NSAIDs include Ibuprofen, Naproxen, Diclofenac, and Piroxicam. Oral contraceptives include Yasmin.
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
| 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: NSAIDs or oral contraceptives 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
Measured: Change from Baseline TCM constitutions at 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: Change from Baseline VAS score at 4 cycles (each cycle is 30 days).
Blood test estrogen
Measured: Change from Baseline blood test at 4 cycles (each cycle is 30 days).
Blood test progesterone
Measured: Change from Baseline blood test at 4 cycles (each cycle is 30 days).
Blood test prostaglandin
Measured: Change from Baseline blood test at 4 cycles (each cycle is 30 days).
Menstrual Distress Questionnaire(MDQ)
Contain: Pain；Concentration；Behavioral Change；Autonomic Reactions；Water Retention；Negative Affect
Measured: Change from Baseline Menstrual Distress Questionnaire at 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 posted5 Mar 2020
- Study start1 Jan 2019
- Primary completion18 Sep 2020 (estimated)
- Study completion18 Sep 2020 (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, Principal investigator, Taipei City HospitalYi-Shuo Huang, Study director, Taipei City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04296422
- Sponsor's protocol ID
- TCHIRB-10712111
- Status last verified
- Feb 2020
- First submitted
- 3 Mar 2020
- Last updated
- 5 Mar 2020
- 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 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Different Acupuncture Dose on Premenstrual Syndrome and the Relationship Between Premenstrual Syndrome and TCM Syndrome Complex
- ClinicalTrials.gov ID
- NCT04296422
- Acronym / sponsor ID
- TCHIRB-10712111
- Conditions
- Premenstrual Syndrome
- Keywords
- Acupuncture, Premenstrual Syndrome, TCM syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Taipei City HospitalOther government
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 18 Sep 2020 (estimated)
- Study completion
- 18 Sep 2020 (estimated)
- First posted
- 5 Mar 2020 (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 design of the study includes 3 groups for women with premenstrual syndrome, 1low dose acupuncture in the low-dose group, 2 high dose acupuncture in the high-dose group, and 3 the drug group (contraceptives) . Serum marker change of PGE2, CA125, E2, and progesterone in enrolled patients will be measured before and after treatment, along with VAS and MDQ questionnaires. The treatment efficacy of different groups and the relationship between PMS and patients TCM syndrome pattern will also be recorded and estimated.
Detailed description
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 (premenstrualdysphoric syndrome, PMDD). The two groups are very similar. PMS is mostly for physical discomfort, while PMDD is for emotional problems, affecting women's sleep seriously.
Regarding the treatment of premenstrual syndrome (PMS), western medicine adopt oral contraceptive pills (OCP) as the first-line medication. However, the common side effects of OCP, such as headache, dizziness, nausea, vomiting, depression, breast pain and so on are also troublesome, In recent years, some women also use acupuncture as an adjunctive replacement therapy because of its safety and fewer side effects. Nevertheless, the factors affecting treatment effect of acupuncture and moxibustion. such as the selection of acupoint s ( of which meridians) or number(dose) of acupuncture ,etc., maight affect the efficacy, yet the relevant research on this issue is not enough. In traditional Chinese medicine theory, acupuncture and moxibustion regulate the energy of the meridians and adjust blood and qi, which in turn help the balance of yin and yang. Female menstrual cycle is a process of conversion between yin and yang in TCM theory. While in western medicine, it is regulated by the endocrine system.
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: NSAIDs or oral contraceptives 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 (1 listed)
- 1.15 to 49 years 2.with a history of regular menstrual cycles (28days±7 days) 3.Symptoms：breast pain、dizziness、bloating、cramps、nausea、vomiting、 diarrhea、headache、 fatigue，etc
Key exclusion criteria (4 listed)
- irregular menstrual cycles
- intrauterine contraceptive device (IUCD/IUD)
- 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 |
|---|---|---|
| NSAIDs or oral contraceptives treatmentAlso: Taking NSAIDs or oral contraceptives.NSAIDs include Ibuprofen, Naproxen, Diclofenac, and Piroxicam. Oral contraceptives include Yasmin.Taking 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 | Device | High dose acupuncture group |
Primary outcome
Wang Qi Chinese Medicine Questionnaire
Time frame: Change from Baseline TCM constitutions at 4 cycles (each cycle is 30 days).
This questionnaire is used to survey TCM constitutions. Evaluate body constitution of
5 secondary outcomes
Visual analogue scale(VAS) score
Time frame: Change from Baseline VAS score at 4 cycles (each cycle is 30 days).
Blood test estrogen
Time frame: Change from Baseline blood test at 4 cycles (each cycle is 30 days).
Blood test progesterone
Time frame: Change from Baseline blood test at 4 cycles (each cycle is 30 days).
Blood test prostaglandin
Time frame: Change from Baseline blood test at 4 cycles (each cycle is 30 days).
Menstrual Distress Questionnaire(MDQ)
Time frame: Change from Baseline Menstrual Distress Questionnaire at 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 5 Mar 2020.
- Individual participant dataSharing planned: No. This study will have a continuous plan.
Related trials for Premenstrual Syndrome
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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
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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.
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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 principal investigator
Taipei City Hospital
Yi-Shuo Huang 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 NSAIDs or oral contraceptives treatment, Low dose acupuncture and High dose acupuncture in people with Premenstrual Syndrome, 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 1 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 5 Mar 2020. 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: Change from Baseline TCM constitutions at 4 cycles (each cycle is 30 days).). 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 5 Mar 2020.