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

Z

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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