A randomised placebo-controlled trial of a traditional chinese herbal formula in the treatment of primary dysmenorrhoea
| ISRCTN | ISRCTN23374750 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23374750 |
| Secondary identifying numbers | N/A |
- Submission date
- 03/10/2002
- Registration date
- 03/10/2002
- Last edited
- 03/10/2007
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Lan Lan Liang Yeh
Scientific
Scientific
Division of Clinical Research
National Health Research Institutes
35 Keyan Road
Zhunan, Miaoli County
35053
Taiwan
| Phone | +886 37 246166 |
|---|---|
| lanlanliang2@yahoo.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | FADD (Four-Agents-Decoction for Dysmenorrhoea) |
| Study objectives | Added as of 23/04/07: Four-Agents-Decoction (Si Wu Tang) is effective in treating primary dysmenorrhoea. |
| Ethics approval(s) | Added as of 23/04/07: Approval received from the Human Ethics Committee, National Health Research Institutes; EC9103001(02/20/2002); EC9106001(11/11/2002); EC0930306 (04/27/2004). |
| Health condition(s) or problem(s) studied | Primary dysmenorrhea |
| Intervention | Two groups: four-agents decoction and placebo, both are in capsule form. Added as of 23/04/07: Two groups: Four-Agents-Dcoction (Si Wu Tang) and placebo, both are in capsule form. Intervention: This Four-Agents-Decoction (Si Wu Tang) will be custom-made with raw materials prepared according to the original pharmacopoeia and concoctioned by water extraction in 1:13 ratio from single batched roots of the four plants in equal proportions: 1. Prepared Radix Rehmanniae praeparata 2. Radix Angelicae sinensis 3. Radix Paeoniae alba, and 4. Rhizoma Ligustici chuanxiong Each capsule contains approximately 500 mg of granules from concentrated decoction, and this is sealed and secured with a band at the interface by a capsule supply company to ensure concealment of the aroma from the materials. Control: The identical looking placebo capsules are filled with a powder mixture of cornstarch and caramel. Regimens of five capsules are packaged in aluminum packets for easier handling and to prevent Four-Agents-Decoction (Si Wu Tang) from moisture exposure. Clinic visit number and case number are to be marked on each packet in both text and bar code. The dosage is 15 capsules daily for five days from the onset of bleeding or pain determined after taking considerations: 1. Habitual usages provided from the three surveys 2. Literature reports 3. A comparison of the concentrations of two indices, paeoniflorin and ferulic acid, in a one-day dose of a commercially available powder with the decoction made from raw materials 4. Information from the studys traditional Chinese medicine physicians, and 5. Input from the studys leading gynaecologist. Ibuprofen tablet (400 mg), four times daily for three days, is provided for unbearable menstrual pain after holding it off. The participants will record the pain intensity they experience right before taking ibuprofen, the intake of all drugs, the use of other remedies, the amount of collected menstrual blood for evaluating menorrhagia if any, and the number of days missing work or school on an online diary. The intervention duration will be three menstrual cycles. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Four-Agents-Decoction (Si Wu Tang) |
| Primary outcome measure | Added as of 23/04/07: Pain intensity evaluated by an online unmarked Visual Analogue Scale (VAS) of one to ten cm matched 1000 scales in our database for the first five days of each menstrual cycle. |
| Secondary outcome measures | Added as of 23/04/07: Uterine artery pulsatility index measured by study gynecologists. |
| Overall study start date | 02/01/2003 |
| Completion date | 16/07/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 78 (added as of 23/04/2007) |
| Key inclusion criteria | College women aged 18 years and older suffering from menstrual pain with no pathological findings. Added as of 23/04/07: 1. College women aged 18 years and older suffering from menstrual pain with no pathological findings 2. Cycles lasting 21 to 35 days with the actual menses periods lasting three to seven days, and having at least four consecutive painful periods in the past six months with the pain starting one day before or on the day of onset of bleeding |
| Key exclusion criteria | Added as of 23/04/07: 1. Taking oral contraceptive pills 2. Unwilling to refrain from sexual activity during the study 3. Having had severe gastrointestinal, gynaecological or autoimmune diseases, or gynaecological surgery, including pregnancy |
| Date of first enrolment | 02/01/2003 |
| Date of final enrolment | 16/07/2004 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
Division of Clinical Research
Zhunan, Miaoli County
35053
Taiwan
35053
Taiwan
Sponsor information
National Health Research Institutes (Taiwan)
Government
Government
35 Keyan Road
Zhunan, Miaoli County
35053
Taiwan
| Website | http://www.nhri.org.tw |
|---|---|
"ROR" |
https://ror.org/02r6fpx29 |
Funders
Funder type
Government
Intramural funding, National Health Research Institutes (Taiwan)
No information available
Added as of 23/04/07:
No information available
A supplemental grant from the Department of Health and The Office of National Science and Technology Program for Biotechnology and Pharmaceuticals (Taiwan)
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 | 15/08/2007 | Yes | No |
