Different Does of Acupuncture on Premenstrual Syndrome Efficacy Analysis

Premenstrual Syndrome Clinical Trial

Official title:

Evaluation of the Effect of Different Acupuncture Dose on Premenstrual Syndrome and the Relationship Between Premenstrual Syndrome and TCM Syndrome Complex

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04296422
• Other study ID #: TCHIRB-10712111
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: September 18, 2020

Study information

• Verified date: February 2020
• Source: Taipei City Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 105
• Est. completion date: September 18, 2020
• Est. primary completion date: September 18, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 49 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

1. irregular menstrual cycles

2. intrauterine contraceptive device (IUCD/IUD)

3. uncontrolled neurological diseases

4. lactation, pregnant women,or those with plans to get pregnant in the coming half year

Related Conditions & MeSH terms

• Premenstrual Syndrome
• Syndrome

Intervention

Drug:
• NSAIDs or oral contraceptives treatment
Taking NSAIDs or oral contraceptives.NSAIDs include Ibuprofen, Naproxen, Diclofenac, and Piroxicam. Oral contraceptives include Yasmin.

Device:
• Low dose acupuncture
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 acupuncture
Twelve acupoints: Three Yin Intersection( SP6)?Grandfather Grandson(SP4)? Sea of Blood(SP10) ?Sea of Qi(RN6)?Origin Pass(RN4) ?Middle Extremity(RN3)?Inner

Locations

Country	Name	City	State
Taiwan	Taipei City H	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei City Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wang Qi Chinese Medicine Questionnaire	This questionnaire is used to survey TCM constitutions. Evaluate body constitution of	Change from Baseline TCM constitutions at 4 cycles (each cycle is 30 days).
Secondary	Visual analogue scale(VAS) score	VAS is used to assess the extent of menstrual pain.	Change from Baseline VAS score at 4 cycles (each cycle is 30 days).
Secondary	Blood test estrogen		Change from Baseline blood test at 4 cycles (each cycle is 30 days).
Secondary	Blood test progesterone		Change from Baseline blood test at 4 cycles (each cycle is 30 days).
Secondary	Blood test prostaglandin		Change from Baseline blood test at 4 cycles (each cycle is 30 days).
Secondary	Menstrual Distress Questionnaire(MDQ)	Contain: Pain;Concentration;Behavioral Change;Autonomic Reactions;Water Retention;Negative Affect	Change from Baseline Menstrual Distress Questionnaire at 4 cycles (each cycle is 30 days).