People with decreased quality of life after childbirth
Conditions
Interventions
Experimental group:Ergotamine capsules, 4 capsules daily, 2 in the morning and 2 in the evening, taken continuously for 1 month.
Placebo group:Placebo capsules, 4 capsules daily, 2 in the morning and 2 in the evening, taken continuously for 1 month.
Sponsors
The First Affiliated Hospital of Anhui University of Science and Technology
Eligibility
Sex/Gender
Female
Age
22 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Women aged 22-40; 2. 6-15 months postpartum, having completely stopped breastfeeding for at least 1 month; 3. Menstruation has resumed (at least one occurrence in the past); 4. Health Survey Short Form (SF-36) total score <=70, indicating quality of life issues; 5. Voluntary participation and signing of informed consent.
Exclusion criteria
Exclusion criteria: 1. Currently breastfeeding (to avoid potential unknown effects on the infant and confounding effects of breastfeeding on symptoms); 2. Clearly diagnosed severe organic diseases (such as severe heart disease, liver or kidney dysfunction, active autoimmune diseases, malignant tumors, uncontrolled thyroid disorders, severe mental illnesses, etc.); 3. Known or suspected allergy to ergotamine or its excipients; 4. Severe sleep disorders: patients with organic sleep disorders such as sleep apnea syndrome, restless legs syndrome, or narcolepsy; 5. Mental disorders: patients with severe depression (EPDS score >=13), anxiety disorders, schizophrenia, or other mental illnesses; 6. Endocrine disorders: patients with hyperthyroidism or hypothyroidism, diabetes, polycystic ovary syndrome, or other endocrine diseases; 7. Systemic diseases: patients with severe heart, liver, kidney, or other systemic diseases; 8. Medication use: use of medications affecting sleep within the past month (such as sleeping pills, antidepressants, hormones, etc.); 9. Nutritional supplements: use of other antioxidant supplements or sleep-improving products within the past month; 10. Special physiological conditions: pregnant, breastfeeding, or planning to become pregnant during the study period; 11. Lifestyle: history of heavy drinking, smoking, or substance abuse; 12. Planning to become pregnant during the study period; 13. Other circumstances deemed by the researcher to make participation in this study unsuitable (such as poor compliance, inability to complete questionnaires, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Health Survey Short Form (SF-36) Scores by Dimension and Total Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fatigue Scale (FS-14);Edinburgh Postnatal Depression Scale (EPDS);Pittsburgh Sleep Quality Index (PSQI);Cortisol in the blood; | — |
Countries
China
Contacts
Public ContactLu Chao
The First Affiliated Hospital of Anhui University of Science and Technology
Outcome results
None listed