Danshen-Jiang-Fu Granule Prepared by Danshen From Different Producing Areas for Primary Dysmenorrhea

The Comparison of the Effect on Danshen-Jiang-Fu Granule Prepared by Danshen (Salvia Miltiorrhiza) From Different Producing Areas (Shandong and Sichuan) for Primary Dysmenorrhea: a Cross-over, Randomized, Double-blind Controlled Trials

This trial aims to compare the effect of Danshen-Jiang-Fu Granule prepared by Danshen (Salvia Miltiorrhiza) from different producing areas (Shandong and Sichuan) for the relief of primary dysmenorrhea.

Inclusion Criteria:

• meeting the diagnostic criteria of primary dysmenorrhea in the Primary Dysmenorrhea Consensus Guideline;
• meeting the diagnostic criteria of Hanning-xueyu(blood stasis due to cold accumulation) Zheng according to Gynecology of Chinese medicine;
• with regular menstrual cycles lasted 21 to 35 days, with menstruation lasting 3 to 9 days in the last 6 months;
• course of dysmenorrhea over 6 months;
• experienced menstrual pain scoring varying from 3cm to 6cm on a 10-cm VAS during the baseline menstrual period (one period prior to present menstrual period with treatment);
• without history of pregnancy;
• with agreement of informed consent and a working phone.

Exclusion Criteria:

• history of abdominal surgery;
• with other acute or chronic painful conditions diagnosed or suspected;
• use of hormonal contraceptives, or intra-uterine device;
• use of analgetic drugs or other analgetic treatment in the last 2 weeks;
• known allergy to Danshen (Salvia Miltiorrhiza), Paojiang (Roasted Ginger), Xiangfu(Rhizoma Cyperi) or Wuyao(Lindera Aggregata);
• prone to allergy in daily life;
• who can not complete treatment adherence to the protocol;
• attending in other trials in the last 3 months.