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EstroG-100 on menopausal women
ISRCTN ISRCTN95953457
DOI 10.1186/ISRCTN95953457
ClinicalTrials.gov identifier
EudraCT number
Public title EstroG-100 on menopausal women
Scientific title The effect of herbal extract (EstroG-100) on pre-, peri- and post-menopausal women: a randomised double-blind placebo-controlled study
Acronym N/A
Serial number at source NET-ESTROG-100-001
Study hypothesis A standardised mixed herbal extract of Cynanchum wilfordii, Phlomis umbrosa, and Angelica gigas was observed to significantly improve the menopausal symptoms of pre-, peri-, post-menopausal women without weight gain or any serious side effects.
Lay summary Not provided at time of registration
Ethics approval Sterling Institutional Review Board (IRB) (USA) approved on the 21st April 2009 (ref: IRB# 3192; NETESTROG-100-001)
Study design Single centre randomised double-blind placebo-controlled study
Countries of recruitment United States of America
Disease/condition/study domain Menopausal symptoms
Participants - 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
Participants - 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)
Anticipated start date 26/05/2009
Anticipated end date 20/01/2010
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 64
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 32.5%, and Angelica gigas Nakai 35%.

The EstroG-100 tablet in the clinical study was comprised of 257.05 mg of EstroG-100, corn starch 164.56 mg, microcrystalline cellulose 186 mg, hydroxypropyl methyl cellulose 50 mg, titanium dioxide 15 mg, silicon dioxide 6.2 mg, magnesium stearate 6.2 mg, glycerin mono fatty acid ester 5 mg, and lac color 5 mg.

The placebo tablet consisted of corn starch 359.61 mg, microcrystalline cellulose 248 mg, hydroxypropyl methyl cellulose 50 mg, titanium dioxide 15 mg, silicon dioxide 6.2 mg, magnesium stearate 6.2 mg, glycerin mono fatty acid ester 5 mg, and lac color 5 mg.

Clinical study and placebo materials were separately formulated into 695 mg purple tablets. The pill bottles were packaged in identical bottles so that neither the research team nor the participants were able to differentiate them by appearance. Participants were instructed to take one tablet twice a day orally for 12 weeks.
Primary outcome measure(s) 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 outcome measure(s) No secondary outcome measures
Sources of funding Ministry for Food, Agriculture, Forestry and Fisheries (South Korea) - Technology Development Program for Agriculture and Forestry
Trial website
Publications 1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/21887807
Contact name Dr  Albert  Chang
  Address 16300 Sand Canyon, Suite 909
  City/town Irvine, CA
  Zip/Postcode 92618
  Country United States of America
  Tel +1 949 585 9870
  Fax +1 949 585 9331
  Email shadycanyon@yahoo.com
Sponsor Naturalendo Tech Co., Ltd (South Korea)
  Address 414, Daerung Post Tower I
212-8, Guro-dong
Guro-gu
  City/town Seoul
  Zip/Postcode 152-790
  Country Korea, South
  Tel +82 (0)2 2082 3120
  Fax +82 (0)2 2082 3140
  Email jskim@naturalendo.co.kr
  Sponsor website: http://www.naturalendo.co.kr
Date applied 08/10/2010
Last edited 15/08/2012
Date ISRCTN assigned 19/10/2010
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