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

NCT02602522 — Early Phase 1, Completed, 91 participants, Zhong Wang

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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

Registry	NCT02602522
Status	Completed
Phase	Early Phase 1
Study type	Interventional; randomized, crossover, masking: quadruple, treatment
Enrollment	91 (Actual)
Sponsor	Zhong Wang (Other)
Conditions	Primary Dysmenorrhea, Traditional Chinese Medicine
Interventions	Shandong Danshen-Jiang-Fu Granule, Sichuan Danshen-Jiang-Fu Granule (Drug)
Dates	start 2015-11-01, primary completion 2018-07-01, completion 2018-08-01, first posted 2015-11-11, last updated 2019-02-05
Locations	1 site in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Experimental	Experimental	Drug: Shandong Danshen-Jiang-Fu Granule; Drug: 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	Active comparator	Drug: Shandong Danshen-Jiang-Fu Granule; Drug: 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.

Shandong Danshen-Jiang-Fu Granule (Drug): 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 (Drug): 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.

+Outcome measures

Primary outcomes

Visual Analogue Scale on the pain of dysmenorrhea [2 months]

Secondary outcomes

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.

+Eligibility

Sex: Female, ages: 14 Years to 25 Years

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.

+Locations (1)

Facility	City	Country	Status
Changzhou TCM hospital	Changzhou, Jiangsu	China

+Investigators

Zhong Wang, Ph.D/M.D., Principal investigator, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences