A randomized controlled study on the treatment of primary dysmenorrhea with heat burning blood stasis by Guizhi Fuling Wa

Phase 1

• Conditions: Primary dysmenorrhea

• Registration Number: ITMCTR2000003429
• Lead Sponsor: Yichang Second People's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Those who meet the following 7 items can be included in the study. If there is any inconformity, the patient cannot enter the study
1. Patients aged 16-30 years;
2. To diagnose patients with primary dysmenorrhea according to the consensus guideline of primary dysmenorrhea;
3. No parturient;
4. Self described pain duration: from 6 months to 15 years;
5. Patients with an average pain intensity of 40 or more (VAS by 100 mm visual analogue scale) and at least three consecutive menstrual cycles;
6. Patients with syndrome of heat burning and blood stasis;
7. The informed consent shall be signed by the patient himself or by his immediate relatives.

Exclusion Criteria

Patients cannot enter the study if any of the following are met:
1. Patients who can not complete the treatment plan of this study within half a year;
2. Patients with secondary dysmenorrhea (such as endometriosis or adenomyosis);
3. Patients with irregular menstrual cycle (beyond the typical range of 21-35 days);
4. Women with pregnancy plan in the past half year;
5. Patients with mental disorders and mental disorders who can not cooperate with the questionnaire survey;
6. Patients with serious cardiovascular disease, liver and kidney function damage, psychological disease or life-threatening situation;
7. Patients who are using analgesics;
8. Patients who have participated in or are participating in other clinical trials.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
visual analog scale (VAS) scores;

Secondary Outcome Measures

Name	Time	Method
Cox Menstrual Symptom Scale (CMSS);Self-rating Anxiety Scale;the TCM syndrome score;Self-rating Depression Scale;