Condition category
Urological and Genital Diseases
Date applied
03/10/2002
Date assigned
03/10/2002
Last edited
03/10/2007
Prospective/Retrospective
Prospectively 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 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 study’s traditional Chinese medicine physicians, and
5. Input from the study’s 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

http://www.nhri.org.tw

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

Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17710126

Publication citations

  1. 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.

Additional files

Editorial Notes