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Completed

NCT Number: NCT02602522

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

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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Key information

Age range

14 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Changzhou TCM hospital

Changzhou, Jiangsu, 213004, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Visual Analogue Scale on the pain of dysmenorrhea

    Time frame: 2 months

Secondary outcomes

  1. Cox Menstrual Symptom Scale

    Time frame: 2 months

  2. Daily Symptom Scale

    Time frame: 2 months

  3. The change on the index of uterine artery doppler ultrasound

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Zhong Wang

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Nov 11, 2015
Registry last updated
Feb 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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