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

Zhong Wang

Status and phase: Completed; Early Phase 1

Conditions: Traditional Chinese Medicine; Primary Dysmenorrhea

Treatments: Drug: Shandong Danshen-Jiang-Fu Granule; Drug: Sichuan Danshen-Jiang-Fu Granule

Study type: Interventional

Funder types: Other

Identifiers

NCT02602522

DS-V3.0

Details and patient eligibility

About

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.

Enrollment: 91 patients

Sex: Female

Ages: 14 to 25 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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91 participants in 2 patient groups

Experimental

Experimental group

Description:

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.

Treatment:

Drug: Sichuan Danshen-Jiang-Fu Granule

Drug: Shandong Danshen-Jiang-Fu Granule

controlled

Active Comparator group

Description:

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.

Treatment:

Drug: Sichuan Danshen-Jiang-Fu Granule

Drug: Shandong Danshen-Jiang-Fu Granule