Different Does of Acupuncture on Premenstrual Syndrome Efficacy Analysis

Status Enrolling by invitation

Clinical 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) . 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04296422
Study type	Interventional
Source	Taipei City Hospital
Contact
Status	Enrolling by invitation
Phase	N/A
Start date	January 1, 2019
Completion date	September 18, 2020

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.