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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02602522
• Other study ID #: DS-V3.0
• Status: Completed
• Phase: Early Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Dysmenorrhea
• Primary Dysmenorrhea
• Traditional Chinese Medicine

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