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Study on the analgesic mechanism of Guizhi Fuling pills Pill in the intervention of primary dysmenorrhea based on the theory of "no pain in general rules

Study on the analgesic mechanism of Guizhi Fuling pills Pill in the intervention of primary dysmenorrhea based on the theory of "no pain in general rules

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000397
Enrollment
Unknown
Registered
2024-09-06
Start date
2024-10-01
Completion date
Unknown
Last updated
2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Dysmenorrhea

Interventions

Experimental group:One week before menstruation and 3 days before menstruation take Guizhi Fuling pill decoction 3g 10 consecutive days per menstrual cycle for 3 consecutive menstrual cycles.
Control group:The use of malt (stir-fried) and grain bud (stir-fried) without similar effects, the packaging and grams are consistent with the test group. One week before menstruation and 3 days befor

Sponsors

Yichang maternal and child Health care Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
15 Years to 35 Years

Inclusion criteria

Inclusion criteria: Experimental group: (1) Meet the diagnostic criteria of PD and cold coagulation and blood stasis syndrome; (2) Age 15-35 years old; (3) Menstrual cycle (28±7) days; (4) did not receive any other treatment in the 1 menstrual cycle before this therapy and did not take sedatives analgesics hormones within 2 weeks before treatment; (5) Sign informed consent and voluntarily participate in this study. Note: Patients who meet the above 5 criteria at the same time can be included in this study. Control group: (1) 18 years old =30 years old; (2) The menstrual cycle is basically normal (28±7 days); (3) Physical examination of various physiological indicators in the normal range no functional or organic diseases; (4) no family history of mental and nervous system; (5) The subjects themselves sign the paper informed consent and volunteer to participate in the experiment. Note: Only healthy subjects who meet all of the above inclusion criteria can be included in this study.

Exclusion criteria

Exclusion criteria: Experimental group: If any of the following meets the criteria the patient will not be admitted to the study: (1) Patients with secondary dysmenorrhea such as uterine fibroids adenomyosis endometriosis and pelvic inflammatory disease were examined; (2) Women in preparation for pregnancy pregnancy and breastfeeding; (3) is using a drug with similar effects to the test drug; (4) Patients with a history of low back pain; (5) Patients with serious primary diseases such as cardiovascular cerebrovascular liver kidney and hematopoietic system; (6) Have mental disorders and mental disorders can not cooperate with the questionnaire investigator; (7) Participants in multiple clinical subjects at the same time; (8) Patients who refuse to sign informed consent. Control group: (1) Pregnant or lactating women within half a year of fertility requirements; (2) long-term users of analgesics and those with alcohol dependence or drug abuse. Note: Healthy subjects who meet any of the above criteria will be excluded.

Design outcomes

Primary

MeasureTime frame
Visual Analogue Scale;

Secondary

MeasureTime frame
Self-Rating Anxiety Scale;Cox Menstrual Symptom Scale;Self-rating depression Scale;Uterine artery blood flow index;Traditional Chinese Medicine Syndrome Score;

Countries

China

Contacts

Public ContactYang Songbai

Yichang maternal and child Health care Hospital

1581190770@qq.com139 7260 6779

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026