Contact information
Type
Scientific
Primary contact
Dr Lan Lan Liang Yeh
ORCID ID
Contact details
Division of Clinical Research
National Health Research Institutes
35 Keyan Road
Zhunan
Miaoli County
35053
Taiwan
+886 37 246166
lanlanliang2@yahoo.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
FADD (Four-Agents-Decoction for Dysmenorrhoea)
Study hypothesis
Added as of 23/04/07:
Four-Agents-Decoction (Si Wu Tang) is effective in treating primary dysmenorrhoea.
Ethics approval
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).
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Four-Agents-Decoction (Si Wu Tang)
Primary outcome measures
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 trial start date
02/01/2003
Overall trial end date
16/07/2004
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
78 (added as of 23/04/2007)
Participant 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
Recruitment start date
02/01/2003
Recruitment end date
16/07/2004
Locations
Countries of recruitment
Taiwan
Trial participating centre
Division of Clinical Research
Zhunan, Miaoli County
35053
Taiwan
Sponsor information
Organisation
National Health Research Institutes (Taiwan)
Sponsor details
35 Keyan Road
Zhunan
Miaoli County
35053
Taiwan
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Intramural funding, National Health Research Institutes (Taiwan)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Added as of 23/04/07:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
A supplemental grant from the Department of Health and The Office of National Science and Technology Program for Biotechnology and Pharmaceuticals (Taiwan)
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
Publication citations
-
Results
Yeh LL, Liu JY, Lin KS, Liu YS, Chiou JM, Liang KY, Tsai TF, Wang LH, Chen CT, Huang CY, A randomised placebo-controlled trial of a traditional Chinese herbal formula in the treatment of primary dysmenorrhoea., PLoS ONE, 2007, 2, 8, e719, doi: 10.1371/journal.pone.0000719.