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Effects of Chicory and Fumitory products on hot flashes

Effects of Chicory and Fumitory products on hot flashes in breast cancer patients

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210226050506N1
Enrollment
64
Registered
2021-06-09
Start date
2021-05-05
Completion date
Unknown
Last updated
2021-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breasts cancer. Malignant neoplasm of breast

Interventions

Intervention 1: Intervention group1: Chicory and Fumitory products, obtained by at Institute of Medicinal Plants of shahid beheshti University, 5 ml per day until the end of the fourth weeks of interv

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Women between 18 and 65 years Breast cancer (stage 0-3) Having at least two hot flashes in 24 hours At least 4 weeks have elapsed since treatment with estrogen suppressive hormone therapy (Tamoxifen, LHRH agonists, Aromatase inhibitors) Estrogen suppressive hormone therapy continued unchanged until the end of the intervention

Exclusion criteria

Exclusion criteria: Lack of informed consent to the plan Life expectancy is less than 6 months Having another cancer at the same time as breast cancer The patient is undergoing chemotherapy, radiotherapy or surgery Use of acupuncture and complementary medicine (hypnosis, psychotherapy) Taking antidepressants in the last 4 weeks Use of Anxiolytic drug, Gabapentin, Pregabalin, Clonidine, Aspirin, Vitamin E, Omega 3, Phytoestrogenic supplements Use of high phytoestrogenic diet Allergy to distillated of Chicory and Fumitory Kidney test (BUN,CR) is not in normal range Laboratory range Liver enzymes AST and ALT are more than twice the normal range Laboratory range and Total Bilirubin =2

Design outcomes

Primary

MeasureTime frame
Number of hot flashes: This variable registered by patient based on definied daily in hot flashes daily registration form. Timepoint: At a specific time of night, it is recorded daily and continuously for one week before the intervention and four weeks during the intervention with drug or placebo. Method of measurement: Number of hot flashes average of frequency during a week according to based on Daily Hot flashes Diary.;The severity of hot flashes in four levels , mild , moderate, severe and very severe, is recorded according to the definition registered by the patient in the Daily hot flashes Diary. Timepoint: At a specific time of night, it is recorded daily and continuously for one week before the intervention and four weeks during the intervention with drug or placebo. Method of measurement: Based on the weekly average daily hot flashes intensity based on the Daily hot flashes Diary.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNematollah Rostami

Shahid Beheshti University of Medical Sciences

alireza.khosropanah1455@gmail.com+98 21 2207 4087

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 11, 2026