premenstrual syndrome
Conditions
Interventions
high-dose group:Ganyushu granules 6g tid po
low-dose group:Ganyushu granules 3g and placebo 3g tid po
placebo group:placebo 6g tid po
Sponsors
Beijing Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1) Be diagnosed as PMS; (2) The menstrual cycle is regular in the past 12 months, which is from 24 to 35 days (24 and 35 days are included), bleeding last from 3 to 7 days (3 and 7 days are included); (3) Fit the TCM syndrome of hepatic qi stagnation; (4) Aged between 18~45 years old; (5) Able to complete PMS symptom diary and self rating scale independently; (6) Signed informed consent.
Exclusion criteria
Exclusion criteria: (1) Be prompted not suitable for clinical trials by reproductive system or breast B-ultrasound, including oophoritic cyst is larger than 5cm, or hysteromyoma is larger than 4cm, or be suspected of breast and reproductive malignant tumors; (2) The plasma progesterone concentration in luteal phase is less than 5ug/L, suggesting ovulation; (3) women who are pregnant or planning pregnancy, lactating women or women who are less than 3 months after the end of lactation; (4) Be assessed in severe anxiety, depression or suicidal tendency by self rating depression scale and self rating anxiety scale; (5) Be diagnosed as schizophrenia, bipolar disorder, anxiety disorder, depression and other mental disorders or somatization disorders; (6) Drugs which have effect on sexual hormones was taken orally in past 6 months or Be injected in past 3 months; drugs for the treatment of mental disorders, such as nerve block drugs, antidepressants, antidepressants, antipsychotics, and other drugs, have been used in the past 3 months; or with certain diseases need to be treated by the afore-mentioned drug; (7) Unwish to use contraceptive methods (excluding sex hormones); (8) ALT and AST is 1.5 times higher than the upper limit of reference value, or Scr exceeded the upper limit of reference value; (9) Combining other diseases such as cardiovascular and cerebrovascular diseases, and liver, kidney, hematopoietic system, endocrine system and so on; (10) Allergy to experimental drugs; (11) Alcohol and drug abusers; (12) Participated in other clinical trials in the past 3 months; (13) Not suitable for participants according to the researchers'judgement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of average PMSD score in progestational stage;The change of PMTS score;The change of TCM syndrome score; | — |
Countries
China
Contacts
Public ContactTeng Xiuxiang
Beijing Hospital of Traditional Chinese Medicine affiliated with Capital Medical University
Outcome results
None listed