Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02602522
Recruitment Status : Completed
First Posted : November 11, 2015
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Zhong Wang, China Academy of Chinese Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Primary Dysmenorrhea Traditional Chinese Medicine Drug: Shandong Danshen-Jiang-Fu Granule Drug: Sichuan Danshen-Jiang-Fu Granule Early Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : November 2015
Actual Primary Completion Date : July 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Period Pain

Arm Intervention/treatment
Experimental: Experimental
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.
Drug: Shandong Danshen-Jiang-Fu Granule
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.

Drug: Sichuan Danshen-Jiang-Fu Granule
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.

Active Comparator: controlled
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.
Drug: Shandong Danshen-Jiang-Fu Granule
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.

Drug: Sichuan Danshen-Jiang-Fu Granule
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 Outcome Measures :
  1. Visual Analogue Scale on the pain of dysmenorrhea [ Time Frame: 2 months ]

Secondary Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   14 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02602522


Locations
Layout table for location information
China, Jiangsu
Changzhou TCM hospital
Changzhou, Jiangsu, China, 213004
Sponsors and Collaborators
Zhong Wang
Investigators
Layout table for investigator information
Principal Investigator: Zhong Wang, Ph.D/M.D. Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

Layout table for additonal information
Responsible Party: Zhong Wang, Chief, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT02602522     History of Changes
Other Study ID Numbers: DS-V3.0
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019

Additional relevant MeSH terms:
Layout table for MeSH terms
Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Neurologic Manifestations
Signs and Symptoms