Primary Dysmenorrhea, Traditional Chinese Medicine
Conditions
Brief 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.
Interventions
DRUGShandong Danshen-Jiang-Fu Granule
Danshen-Jiang-Fu Granule is prepared from 4 kinds of Chinese herbs including Danshen (Salvia Miltiorrhiza), Paojiang (Roasted Ginger), Xiangfu(Rhizoma Cyperi), Wuyao(Lindera Aggregata). The producing area of Danshen in Shandong Danshen-Jiang-Fu Granule is Laiwu District in Shandong province.
DRUGSichuan Danshen-Jiang-Fu Granule
Danshen-Jiang-Fu Granule is prepared from 4 kinds of Chinese herbs including Danshen (Salvia Miltiorrhiza), Paojiang (Roasted Ginger), Xiangfu(Rhizoma Cyperi), Wuyao(Lindera Aggregata). The producing area of Danshen in Sichuan Danshen-Jiang-Fu Granule is Zhongjiang District in Sichuan province.
Sponsors
Zhong Wang
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 25 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale on the pain of dysmenorrhea | 2 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cox Menstrual Symptom Scale | 2 months | — |
| Daily Symptom Scale | 2 months | — |
| The change on the index of uterine artery doppler ultrasound | 2 months | 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. |
Countries
China
Outcome results
None listed