Back to resultsDanshen-Jiang-Fu Granule Prepared by Danshen From Different Producing Areas for Primary Dysmenorrhea
Primary Purpose
Primary Dysmenorrhea, Traditional Chinese Medicine
Status
Completed
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Shandong Danshen-Jiang-Fu Granule
Sichuan Danshen-Jiang-Fu Granule
Sponsored by
About this trial
This is an interventional treatment trial for Primary Dysmenorrhea
Eligibility 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.
Sites / Locations
- Changzhou TCM hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental
controlled
Arm 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.
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.
Outcomes
Primary Outcome Measures
Visual Analogue Scale on the pain of dysmenorrhea
Secondary Outcome Measures
Cox Menstrual Symptom Scale
Daily Symptom Scale
The change on the index of uterine artery doppler ultrasound
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02602522
Brief Title
Danshen-Jiang-Fu Granule Prepared by Danshen From Different Producing Areas for Primary Dysmenorrhea
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
August 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhong Wang
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dysmenorrhea, Traditional Chinese Medicine
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm 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.
Arm Title
controlled
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Shandong Danshen-Jiang-Fu Granule
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Sichuan Danshen-Jiang-Fu Granule
Intervention Description
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 Measure Information:
Title
Visual Analogue Scale on the pain of dysmenorrhea
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Cox Menstrual Symptom Scale
Time Frame
2 months
Title
Daily Symptom Scale
Time Frame
2 months
Title
The change on the index of uterine artery doppler ultrasound
Description
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.
Time Frame
2 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhong Wang, Ph.D/M.D.
Organizational Affiliation
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changzhou TCM hospital
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213004
Country
China
12. IPD Sharing Statement
Learn more about this trial
Danshen-Jiang-Fu Granule Prepared by Danshen From Different Producing Areas for Primary Dysmenorrhea
We'll reach out to this number within 24 hrs