EstroG-100 on menopausal women

The effect of herbal extract (EstroG-100) on pre-, peri- and post-menopausal women: a randomised double-blind placebo-controlled study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN95953457

Enrollment

Registered

2010-10-19

Start date

2009-05-26

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Menopausal symptoms Urological and Genital Diseases Menopause

Interventions

Qualified participants were provided with either EstroG-100 or placebo pill bottles. EstroG-100 (or FGF-271) is a standardised mixed root extract of Cynanchum wilfordii 32.5%, Phlomis umbrosa Turcz 32

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Women aged between 42 and 70 years 2. Moderate or severe menopausal symptoms (score of greater than or equal to 20) identified by a simplified questionnaire with the Kupperman Menopause Index (KMI) 3. Eligibility was re-examined with the results of laboratory, mammogram, and pelvic ultrasound tests

Exclusion criteria

Exclusion criteria: 1. Concurrent use of dietary supplement for menopause symptoms 2. Any suspicion of breast or endometrial malignancy 3. History of using oestrogen or progestin-containing products in past 3 months 4. Psychoactive drugs 5. Body mass index (BMI) greater than 40 kg/m^2 6. Irregular gynaecological bleeding 1 year after menopause 7. Hysterectomy 8. Uncontrolled hypertension 9. Thyroid disease 10. Diabetes mellitus 11. History of hormone-dependent (gynaecological) cancer 12. Drug and alcohol abuse 13. Mental disorder 14. Abnormality in renal and liver functions 15. Personal or family history of breast cancer in first degree relative 16. History of clotting disorder such as deep vein thrombosis (DVT)

Design outcomes

Primary

Measure	Time frame
1. Mean change in scores of self-scored Kupperman Menopause Index (KMI) 2. Mean change in scores of each symptom of the questionnaire from KMI 3. Mean change in scores of vaginal dryness The KMI includes hot flash or cold sweat (vasomotor), numbness and tingling (paresthesia), trouble sleeping (insomnia), nervousness, feeling blue or depressed (melancholia), dizzy spells (vertigo), tired feelings (fatigue), rheumatic pain (arthralgia and myalgia), headaches, pounding of the heart (palpitation), and sensation of crawling on the skin (formication).	—

Measure

Time frame

1. Mean change in scores of self-scored Kupperman Menopause Index (KMI) 2. Mean change in scores of each symptom of the questionnaire from KMI 3. Mean change in scores of vaginal dryness The KMI includes hot flash or cold sweat (vasomotor), numbness and tingling (paresthesia), trouble sleeping (insomnia), nervousness, feeling blue or depressed (melancholia), dizzy spells (vertigo), tired feelings (fatigue), rheumatic pain (arthralgia and myalgia), headaches, pounding of the heart (palpitation), and sensation of crawling on the skin (formication).

—

Secondary

Measure	Time frame
No secondary outcome measures	—

Countries

United States of America

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026