Primary Dysmenorrhea Clinical Trial
Official title:
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
Verified date | February 2019 |
Source | China Academy of Chinese Medical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 91 |
Est. completion date | August 2018 |
Est. primary completion date | July 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 14 Years to 25 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | Changzhou TCM hospital | Changzhou | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Zhong Wang |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual Analogue Scale on the pain of dysmenorrhea | 2 months | ||
Secondary | Cox Menstrual Symptom Scale | 2 months | ||
Secondary | Daily Symptom Scale | 2 months | ||
Secondary | The change on the index of uterine artery doppler ultrasound | The index of uterine artery doppler ultrasound include resistance index (RI) values and the ratio between peak systolic to end-diastolic flow velocity (S/D) in uterine ascending arteries. | 2 months |
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