NCT00420576

Brief Summary

Main purpose of the study is to look for an optimal dose for the treatment of menopausal symptoms with the Chinese Herbal Medicines containing Dang Gui and Huang Qi.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

December 18, 2008

Status Verified

January 1, 2007

Enrollment Period

1.5 years

First QC Date

January 9, 2007

Last Update Submit

December 17, 2008

Conditions

Postmenopausal

Keywords

Post-menopausalTraditional Chinese MedicineRandomized

Outcome Measures

Primary Outcomes (1)

  • the changes in severity and frequency of hot flushes and sweats (menopausal symptoms)

    5 Months

Secondary Outcomes (2)

  • the changes of score on the Menopause specific quality of life

    5 Months

  • the changes in values of various markers of risk for cardiovascular disease

    5 Months

Study Arms (3)

1

EXPERIMENTAL

Low Dose Danggui Buxue Tang (1.5g)

Drug: DBT-Danggui Buxue Tang

2

EXPERIMENTAL

Middle Dose Danggui Buxue Tang(3g)

Drug: DBT-Danggui Buxue Tang

3

EXPERIMENTAL

High Dose Danggui Buxue Tang (6g)

Drug: DBT-Danggui Buxue Tang

Interventions

DBT-Danggui Buxue TangDRUG

Herbal Combination of Danggui (Radix Angelicae Sinensis) and Huangqi (Radix Astragali)in granules form, in 3 different dosage 6g/3g/1.5g, once time per day for 3 Months treatment

Also known as: Danggui Buxue Tang
123

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Follicle stimulating hormone (FSH), luteinizing hormone (LH), oestradiol in the menopausal range (FSH\>18 IU/L, LH\>12.6 IU/L, and E2\< 361 pmol/l)
  • Patients with amenorrhoea for more than 12 months
  • Never received treatment for menopausal symptoms
  • Never received menopausal hormone therapy
  • Reporting a minimum of 21 hot flushes per week at the time of entry into the study

You may not qualify if:

  • Patients with a history of using Chinese medicine or other therapies which may affect the outcome within 8 weeks
  • Patients who in the judgment of the investigator will be unable to comply with protocol requirements.
  • Patients with significant gastrointestinal, renal, hepatic, bronchopulmonary, neurological, cardiovascular, breast or endometrial carcinoma, or allergic diseases;
  • Patients with uncontrolled hypertension,
  • Patients with undiagnosed vaginal bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics & Gynaecology, CUHK, Prince of Wales Hospital

Hong Kong, China

Location

Related Publications (9)

  • Hagstad A, Janson PO. The epidemiology of climacteric symptoms. Acta Obstet Gynecol Scand Suppl. 1986;134:59-65. doi: 10.3109/00016348609157052.

    PMID: 3468732BACKGROUND

  • Schneider HP, Gallagher JC. Moderation of the daily dose of HRT: benefits for patients. Maturitas. 1999 Nov;33 Suppl 1:S25-9. doi: 10.1016/s0378-5122(99)00060-2.

    PMID: 10661612BACKGROUND

  • Au GK. Evaluation of the benefits and risks of hormone replacement therapy. Hong Kong Med J. 2000 Dec;6(4):381-9.

    PMID: 11177160BACKGROUND

  • Blumel JE, Castelo-Branco C, Binfa L, Gramegna G, Tacla X, Aracena B, Cumsille MA, Sanjuan A. Quality of life after the menopause: a population study. Maturitas. 2000 Jan 15;34(1):17-23. doi: 10.1016/s0378-5122(99)00081-x.

    PMID: 10687878BACKGROUND

  • Hall G, Pripp U, Schenck-Gustafsson K, Landgren BM. Long-term effects of hormone replacement therapy on symptoms of angina pectoris, quality of life and compliance in women with coronary artery disease. Maturitas. 1998 Jan 12;28(3):235-42. doi: 10.1016/s0378-5122(97)00080-7.

    PMID: 9571599BACKGROUND

  • Zhu DP. Dong quai. Am J Chin Med. 1987;15(3-4):117-25. doi: 10.1142/S0192415X87000151.

    PMID: 3425569BACKGROUND

  • Davis SR, Briganti EM, Chen RQ, Dalais FS, Bailey M, Burger HG. The effects of Chinese medicinal herbs on postmenopausal vasomotor symptoms of Australian women. A randomised controlled trial. Med J Aust. 2001 Jan 15;174(2):68-71. doi: 10.5694/j.1326-5377.2001.tb143156.x.

    PMID: 11245505BACKGROUND

  • Fugh-Berman A. Herb-drug interactions. Lancet. 2000 Jan 8;355(9198):134-8. doi: 10.1016/S0140-6736(99)06457-0.

    PMID: 10675182BACKGROUND

  • Chung TK, Yip SK, Lam P, Chang AM, Haines CJ. A randomized, double-blind, placebo-controlled, crossover study on the effect of oral oestradiol on acute menopausal symptoms. Maturitas. 1996 Oct;25(2):115-23. doi: 10.1016/0378-5122(96)01050-x.

    PMID: 8905602BACKGROUND

MeSH Terms

Interventions

danggui buxue decoction

Study Officials

  • Christopher J Haines, FPOGS

    Department of Obstetrics & Gynaecology, CUHK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 9, 2007

First Posted

January 11, 2007

Study Start

June 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

December 18, 2008

Record last verified: 2007-01

Locations

CN(1)