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Study for mechanism and efficacy of acupuncture in the treatment of severe premenstrual syndrome

Phase 1
Recruiting
Conditions
Women and children's disease
2015M01
Registration Number
ITMCTR1900002425
Lead Sponsor
First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Female
Target Recruitment
Not specified
Inclusion Criteria

1. Women aged between 18 and 35, who met the diagnostic criteria of moderate and severe premenstrual tension syndrome;
2. The regularity of menstrual cycle is 28-35 days;
3. Ability to read and write;
4. Voluntarily to be involved in the study and sign the informed consent;
5. The total score of DRSP in the first five days of two consecutive menstrual cycles is greater than or equal to 130 points.

Exclusion Criteria

1. With serious heart, brain and kidney diseases, hypertension, diabetes and so on;
2. Recent six months of treatment for premenstrual tension syndrome;
3. Recent month received other medication;
4. It is anticipated that during the study period, the treatment of subjects with more than one menstrual cycle will be discontinued. Can not attend follow-up as required (telephone or e-mail follow-up);
5. Participate in other clinical researchers in the past month;
6. Recent six months received psychiatric drugs or other medications that affected the study;
7. Pregnant subjects or planned pregnant subjects;
8. Pelvic ultrasound has any organic lesions;
9. Have a history of mental illness;
10. Take analgesics in the past month;
11. Acupuncture treatment has been given in the past six months;
12. There are subjects with alcohol abuse, drug abuse history, attempted suicide and severe personality disorders. Alcohol abuse is defined as > 14 cups per week or binge drinking.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
eurotransmitter indices;DRSP Rating;Serum hormone index;
Secondary Outcome Measures
NameTimeMethod
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