Condition category
Urological and Genital Diseases
Date applied
04/05/2006
Date assigned
02/06/2006
Last edited
20/09/2007
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 Alex Liew

ORCID ID

Contact details

497 South Road
Ashford
South Australia
5035
Australia
+61 (0)8 83713711
endoherb@tpg.com.au

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HEC 02/098

Study information

Scientific title

Acronym

Endoherb

Study hypothesis

The hypothesis is that the formulated Chinese herbal treatment shows no significant difference than a placebo in the management of the symptoms of endometriosis.

Ethics approval

Ethics approval received from the University of Western Sydney's Ethics Committee on the 8th August 2002 (ref: HEC 02/098).

Study design

A multicentre, randomised, double-blind, placebo-controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Endometriosis

Intervention

A specific Chinese herbal formula (Endoherb) versus placebo.

Intervention type

Drug

Phase

Not Specified

Drug names

Endoherb

Primary outcome measures

Pain intensity due to endometriosis, measured quantitatively on the VAS and qualitatively as descriptive values.

Secondary outcome measures

1. Quality of life using the 36-item Short-Form health survey (SF-36) and a study design health survey tool
2. Serum CA 125 levels

Overall trial start date

15/11/2004

Overall trial end date

15/11/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women, aged 18 - 43 years
2. Diagnosed with endometriosis by laparoscopy and the severity staged (grade I - IV)
3. At least three months of pain measuring more than 30 mm on visual analogue scale (VAS) scale

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

100 participants (50 in each arm)

Participant exclusion criteria

1. Menopause
2. Pregnancy
3. Liver diseases
4. Suffering from diabetes mellitus
5. Suffering from malignancies
6. Hormonal treatments
7. Anti-depressant treatments
8. Immunosuppressive conditions and treatments

Recruitment start date

15/11/2004

Recruitment end date

15/11/2005

Locations

Countries of recruitment

Australia

Trial participating centre

497 South Road
South Australia
5035
Australia

Sponsor information

Organisation

University of Western Sydney (Australia)

Sponsor details

Centre for Complementary Medicine
Locked Bag 1797
Penrith South DC
New South Wales
Sydney
1797
Australia

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University of Western Sydney (Australia)

Alternative name(s)

UWS

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Australia

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

Publication citations

Additional files

Editorial Notes