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

Early Phase 1

Completed

• Conditions: Traditional Chinese Medicine; Primary Dysmenorrhea
• Interventions: Drug: Shandong Danshen-Jiang-Fu Granule; Drug: Sichuan Danshen-Jiang-Fu Granule

• Registration Number: NCT02602522
• Lead Sponsor: Zhong Wang

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-07
• Study First Submitted QC: 2015-11-10
• Study First Posted: 2015-11-11
• Primary Completion: 2018-07
• Study Completion: 2018-08
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 91

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Experimental	Shandong Danshen-Jiang-Fu Granule	The patients in this arm will be given 1 bag per time of Shandong Danshen-Jiang-Fu Granule, twice a day for 5 days before menorrhea and the first 2 days in the first menorrhea period. And then in the next menstrual cycle, the patients will in turn be given 1 bag per time of Sichuan Danshen-Jiang-Fu Granule, twice a day for 5 days before menorrhea and the first 2 days in the second menorrhea period.
Experimental	Sichuan Danshen-Jiang-Fu Granule	The patients in this arm will be given 1 bag per time of Shandong Danshen-Jiang-Fu Granule, twice a day for 5 days before menorrhea and the first 2 days in the first menorrhea period. And then in the next menstrual cycle, the patients will in turn be given 1 bag per time of Sichuan Danshen-Jiang-Fu Granule, twice a day for 5 days before menorrhea and the first 2 days in the second menorrhea period.
controlled	Shandong Danshen-Jiang-Fu Granule	The patients in this arm will be given 1 bag per time of Sichuan Danshen-Jiang-Fu Granule prepared, twice a day for 5 days before menorrhea and the first 2 days in the first menorrhea period. And then in the next menstrual cycle, the patients will in turn be given 1 bag per time of Shandong Danshen-Jiang-Fu Granule, twice a day for 5 days before menorrhea and the first 2 days in the second menorrhea period.
controlled	Sichuan Danshen-Jiang-Fu Granule	The patients in this arm will be given 1 bag per time of Sichuan Danshen-Jiang-Fu Granule prepared, twice a day for 5 days before menorrhea and the first 2 days in the first menorrhea period. And then in the next menstrual cycle, the patients will in turn be given 1 bag per time of Shandong Danshen-Jiang-Fu Granule, twice a day for 5 days before menorrhea and the first 2 days in the second menorrhea period.

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale on the pain of dysmenorrhea	2 months

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Changzhou TCM hospital; 🇨🇳 Changzhou, Jiangsu, China