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

NCT02602522 | Completed Early Phase 1

• 1 other identifier: DS-V3.0
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Dysmenorrhea; Traditional Chinese Medicine

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale on the pain of dysmenorrhea

  2 months

Secondary Outcomes (3)

• Cox Menstrual Symptom Scale

  2 months

• Daily Symptom Scale

  2 months

• The change on the index of uterine artery doppler ultrasound

  2 months

Study Arms (2)

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; Drug: Sichuan Danshen-Jiang-Fu Granule

controlled

ACTIVE COMPARATOR

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; Drug: Sichuan Danshen-Jiang-Fu Granule

Interventions

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.

Experimental; controlled

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.

Experimental; controlled

Eligibility Criteria

• Age: 14 Years - 25 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhong Wang: lead

Study Sites (1)

Changzhou TCM hospital

Changzhou, Jiangsu, 213004, China

Location

Study Officials

• Zhong Wang, Ph.D/M.D.

  Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief

Study Record Dates

• First Submitted: November 7, 2015
• First Posted: November 11, 2015
• Study Start: November 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: August 1, 2018
• Last Updated: February 5, 2019

Record last verified: 2019-02

Locations

CN (1)