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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02602522
Other study ID # DS-V3.0
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date November 2015
Est. completion date August 2018

Study information

Verified date February 2019
Source China Academy of Chinese Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design


Intervention

Drug:
Shandong 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.
Sichuan 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.

Locations

Country Name City State
China Changzhou TCM hospital Changzhou Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Zhong Wang

Country where clinical trial is conducted

China, 

Outcome

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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