Effect of Belladonna/Ergotamine/Phenobarbital on Menopausal Symptoms

Not Applicable

Completed

• Conditions: Menopausal 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; Belladonna/Ergotamine/Phenobarbital; hot flushes or night sweat

• Registration Number: TCTR20151208001
• Lead Sponsor: Faculty of Medicine, Khon Kean University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2015-11-30
• Study Start: 2015-12-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 70

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change in severity of hot flushes 8 weeks interval Analysis of Covariance

Secondary Outcome Measures

Name	Time	Method
Quality of life in menopausal women after treatment 8 weeks interval Analysis of Covariance