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

• Status: Completed
• Trial end date: 2018-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhong Wang

Criteria

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.