A multicentre, randomised, double-blind, placebo-controlled clinical trial to evaluate the use of Chinese herbal medicine in the management of endometriosis: a prospective study
| ISRCTN | ISRCTN19413357 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19413357 |
| Protocol serial number | HEC 02/098 |
| Sponsor | University of Western Sydney (Australia) |
| Funder | University of Western Sydney (Australia) |
- Submission date
- 04/05/2006
- Registration date
- 02/06/2006
- Last edited
- 20/09/2007
- 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
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Alex Liew
Scientific
Scientific
497 South Road
Ashford
South Australia
5035
Australia
| Phone | +61 (0)8 83713711 |
|---|---|
| endoherb@tpg.com.au |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | A multicentre, randomised, double-blind, placebo-controlled clinical trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | Endoherb |
| Study objectives | 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(s) | Ethics approval received from the University of Western Sydney's Ethics Committee on the 8th August 2002 (ref: HEC 02/098). |
| Health condition(s) or problem(s) studied | Endometriosis |
| Intervention | A specific Chinese herbal formula (Endoherb) versus placebo. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Endoherb |
| Primary outcome measure(s) |
Pain intensity due to endometriosis, measured quantitatively on the VAS and qualitatively as descriptive values. |
| Key secondary outcome measure(s) |
1. Quality of life using the 36-item Short-Form health survey (SF-36) and a study design health survey tool |
| Completion date | 15/11/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 100 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 15/11/2004 |
| Date of final enrolment | 15/11/2005 |
Locations
Countries of recruitment
- Australia
Study participating centre
497 South Road
South Australia
5035
Australia
5035
Australia
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
