EstroG-100 on menopausal women

ISRCTN	ISRCTN95953457
DOI	https://doi.org/10.1186/ISRCTN95953457
Secondary identifying numbers	NET-ESTROG-100-001

Submission date: 08/10/2010
Registration date: 19/10/2010
Last edited: 15/08/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr Albert Chang
Scientific

16300 Sand Canyon, Suite 909
Irvine, CA
92618
United States of America

Phone	+1 949 585 9870
Email	shadycanyon@yahoo.com

Study information

Study design	Single centre randomised double-blind placebo-controlled study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	The effect of herbal extract (EstroG-100) on pre-, peri- and post-menopausal women: a randomised double-blind placebo-controlled study
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.
Ethics approval(s)	Sterling Institutional Review Board (IRB) (USA) approved on the 21st April 2009 (ref: IRB# 3192; NETESTROG-100-001)
Condition	Menopausal symptoms
Intervention	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.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase IV
Drug / device / biological / vaccine name(s)	EstroG-100
Primary outcome measure	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 measures	No secondary outcome measures
Overall study start date	26/05/2009
Overall study end date	20/01/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	64
Participant 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
Participant 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)
Recruitment start date	26/05/2009
Recruitment end date	20/01/2010

Locations

Countries of recruitment

United States of America

Study participating centre

16300 Sand Canyon, Suite 909

Irvine, CA
92618
United States of America

Sponsor information

Naturalendo Tech Co., Ltd (South Korea)
Industry

414, Daerung Post Tower I
212-8, Guro-dong
Guro-gu
Seoul
152-790
Korea, South

Phone	+82 (0)2 2082 3120
Email	jskim@naturalendo.co.kr
Website	http://www.naturalendo.co.kr

Funders

Funder type

Government

Ministry for Food, Agriculture, Forestry and Fisheries (South Korea) - Technology Development Program for Agriculture and Forestry

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2012		Yes	No