Condition category
Urological and Genital Diseases
Date applied
08/10/2010
Date assigned
19/10/2010
Last edited
15/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Albert Chang

ORCID ID

Contact details

16300 Sand Canyon
Suite 909
Irvine
CA
92618
United States of America
+1 949 585 9870
shadycanyon@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NET-ESTROG-100-001

Study information

Scientific title

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

Acronym

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

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Phase IV

Drug names

EstroG-100

Primary outcome measures

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 trial start date

26/05/2009

Overall trial end date

20/01/2010

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Female

Target number of participants

64

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

Trial participating centre

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

Sponsor information

Organisation

Naturalendo Tech Co., Ltd (South Korea)

Sponsor details

414
Daerung Post Tower I
212-8
Guro-dong
Guro-gu
Seoul
152-790
Korea
South
+82 (0)2 2082 3120
jskim@naturalendo.co.kr

Sponsor type

Industry

Website

http://www.naturalendo.co.kr

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/21887807

Publication citations

  1. Results

    Chang A, Kwak BY, Yi K, Kim JS, The effect of herbal extract (EstroG-100) on pre-, peri- and post-menopausal women: a randomized double-blind, placebo-controlled study., Phytother Res, 2012, 26, 4, 510-516, doi: 10.1002/ptr.3597.

Additional files

Editorial Notes