Menopausal women with vasomotor symptoms (hot flushes or night sweat) predominate with or without the following symptoms: insomnia,
Conditions
Interventions
Combination of anticholinergic,
ergot alkaloid (dopamine agonist) and anti-
seizure drug to alleviate vasomotor symptoms in menopausal women,Placebo was conducted to mimic Belladonna/Ergotamine/Phenobarbital by Faculty of Pharmacy,
Khon Kaen University. General appearance,
taste and smell are similar to real drug but no active ingredients.
Active Comparator Drug,Placebo Comparator Drug
Belladonna/Ergotamine/Phenobarbital,Placebo
Sponsors
Faculty of Medicine, Khon Kean University
Eligibility
Sex/Gender
Female
Age
45 Years to 55 Years
Inclusion criteria
Inclusion criteria: Peri- or postmenopausal women with vasomotor symptoms (hot flushes or night sweat) predominate with or without the following symptoms: insomnia, headache, dizziness, palpitation, anxiety, depress, fatique and loss
Exclusion criteria
Exclusion criteria: Drinking alcohol or smoking Drug abuse History of allergy to Belladonna or ergotamine or phenobarbital Underlying diseases of the following: asthma, acute narrow angle glaucoma, severe arteriosclerosis, thrombophlebitis, hypertension, intestinal atony, ulcerative colitis, severe pruritis, porphyria, myocardial infarction, hypo- or hyperthyroidism, abnormal level of liver function or renal function, depression Taking hormonal therapy or monoamine oxidase inhibitor (MAOIs)ex. phenelzine sulfate, selegiline or protease inhibitors or macrolides
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in severity of hot flushes 8 weeks interval Analysis of Covariance | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life in menopausal women after treatment 8 weeks interval Analysis of Covariance | — |
Countries
Thailand
Contacts
Public ContactWoraluck Somboonporn
mdcli07@kku.a.c.th
Outcome results
None listed