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Evaluation of the effect of an herbal medication on severity, frequency and duration of hot flashes in menopausal wome

Phase 2
Conditions
Hot flashes in peri and postmenopausal women.
Menopausal and female climacteric states
Registration Number
IRCT138710241548N1
Lead Sponsor
Deputy of Research of Shiraz University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
Female
Target Recruitment
100
Inclusion Criteria

(1) natural perimenopuse (3-11 months of amenorrhea or increased menstrual irregularity if still cycling) or postmenopause (12 or more months of amenorrhea) (2) untreated complaints for at least 2 months, (3) no history of cancer, (4) moderate to severe hot flashes happening at least once a day, (5) lack of illnesses creating hot flash-like symptoms, (6) presenting the serum level of FSH more than 40 mlu/ml. Exclusion criteria: (1) treatment with sexual hormones, nonhormonal climacteric drugs, or any treatment to alleviate climacteric symptoms in the last 12 weeks before study entry, (2) treatment with chemical or plant-derived medicines in the last 12 weeks before study entry, (3) bilateral oophorectomy, and (4) severe diseases (e.g., of the heart, liver, kidney, alimentary system, or metabolic diseases) or abnormal thyroid-stimulating hormone value that could mimic climacteric complaints or the actual or expected treatment or that could interfere with the study objectives.

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Decrease of the severity, frequency and duration of hot flashes. Timepoint: one month. Method of measurement: Kupperman Index.
Secondary Outcome Measures
NameTimeMethod
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