Migraine, chronic insomnia, gastroesophageal reflux disease and premenstrual syndrome with liver depression transforming into heat syndrome
Conditions
Interventions
migraine group:Qingganjieyufang Granules
chronic insomnia group:Qingganjieyufang Granules
Acid reflux disease:Qingganjieyufang Granules
Premenstrual syndrome:Qingganjieyufang Granules
Sponsors
Dongzhimen Hospital, Beijing University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Migraine (1) Meets the diagnostic criteria of migraine without aura, migraine with typical aura or chronic migraine in the International Classification of Headache Disorders, 3rd Edition; (2) Aged 18-65 years, and the initial age is = 18 years, regardless of gender; (3) Liver depression transforming into heat syndrome; (4) Sign the informed consent form. 3. Gastroesophageal reflux disease (1) Comply with the diagnostic criteria of gastroesophageal reflux disease in "Expert Consensus Opinions on TCM Diagnosis and Treatment of Gastroesophageal Reflux Disease (2017)"; (2) Liver depression transforming into heat syndrome; (3) Age 18-80 years old, regardless of gender; (4) Sign the informed consent form. 4. Dremenstrual syndrome (1) Meet the diagnostic criteria for premenstrual syndrome (PMS) recommended by American College of Obstetricians and Gynecologists (ACOG) in 2014; (2) Liver depression transforming into heat syndrome; (3) Between the ages of 18 and 45; (4) Regular menstruation in recent 12 months, with menstrual cycle of 21~35 days (including 21 and 35 days); (5) Sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Migraine (1) Headache caused by organic disease; (2) Severe mental illness or suicidal tendency; (3) Patients with acute cerebrovascular disease, severe liver and kidney function injury, hematopoietic system and other serious primary diseases; (4) Participants in other clinical trials in recent 1 month; (5) Women who are pregnant, breast-feeding or have pregnancy plans in recent 3 months; (6) Allergic to traditional Chinese medicine ingredients of Qinggan Jieyu Fang. 2. Chronic insomnia (1) Severe mental illness or suicidal tendency; (2) Patients with acute cerebrovascular disease, severe liver and kidney function injury, hematopoietic system and other serious primary diseases; (3) Participants in other clinical trials in recent 1 month; (4) Pregnant, lactating women or women with pregnancy plans in recent 3 months; (5) Allergic to traditional Chinese medicine ingredients of Qinggan Jieyu Fang. 3. Gastroesophageal reflux disease (1) Patients with peptic ulcer, history of esophageal and (or) gastric surgery and malignant lesions, Zollinger-Ellison syndrome, achalasia and other primary esophageal motility diseases, physical and chemical esophageal mucosal injury, pyloric obstruction; (2) Severe mental illness or suicidal tendency; (3) Patients with acute cerebrovascular disease, severe liver and kidney function injury, hematopoietic system and other serious primary diseases; (4) Participants in other clinical trials in recent 1 month; (5) Women who are pregnant, breast-feeding or have pregnancy plans in recent 3 months; (6) Allergic to traditional Chinese medicine ingredients of Qinggan Jieyu Fang. 4. Premenstrual syndrome (1) Endometriosis, hysteromyoma, breast tumor, malignant tumor of reproductive system, polycystic ovary syndrome, hyperprolactinemia, ovarian hypofunction, ovarian cyst, hyperthyroidism or hypothyroidism, pituitary tumor and other diseases; (2) Severe mental illness or suicidal tendency; (3) Patients with acute cerebrovascular disease, severe liver and kidney function injury, hematopoietic system and other serious primary diseases; (4) Participants in other clinical trials in recent 1 month; (5) Women who are pregnant, breast-feeding or have pregnancy plans in recent 3 months; (6) Allergic to traditional Chinese medicine ingredients of Qinggan Jieyu Fang.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Syndrome Evaluation Scale for Liver Stagnation Transforming into Heat Syndrome;shuimian; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life SF-12;Headache Impact Test (HIT);Migraine Remission PRO Scale;Insomnia Severity Scale (ISI);Gastroesophageal reflux disease questionnaire (GerdQ);Concomitant Medication;Symptom severity recorded daily DRSP;Number of headache attacks;Headache Onset Days;Insomnia response rate;three sex hormone;Medication compliance;Migraine-specific quality of life scale;The acid reflux disease health quality of life scale;Average VAS score at headache onset; | — |
Countries
China
Contacts
Public ContactCao Kegang
Dongzhimen Hospital, Beijing University of Traditional Chinese Medicine
Outcome results
None listed