Dose Finding Study of Danggui Buxue Tang (Herbal Formula)on the Treatment of Menopausal Symptoms

NCT00420576 ↗

Phase 2 Completed 60 enrolled Chinese University of Hong Kong

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start: 2006-06
Primary completion: 2007-12
Completion: 2007-12

Publications

Background Hagstad A, Janson PO. The epidemiology of climacteric symptoms. Acta Obstet Gynecol Scand Suppl. 1986;134:59-65. doi: 10.3109/00016348609157052.
Background 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.
Background Au GK. Evaluation of the benefits and risks of hormone replacement therapy. Hong Kong Med J. 2000 Dec;6(4):381-9.
Background 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.
Background 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.
Background Zhu DP. Dong quai. Am J Chin Med. 1987;15(3-4):117-25. doi: 10.1142/S0192415X87000151.
Background 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.
Background Fugh-Berman A. Herb-drug interactions. Lancet. 2000 Jan 8;355(9198):134-8. doi: 10.1016/S0140-6736(99)06457-0.
Background 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	DBT-Danggui Buxue Tang	Unknown	1.5 g	—
Subject	DBT-Danggui Buxue Tang	Unknown	3 g	—
Subject	DBT-Danggui Buxue Tang	Unknown	6 g	—

Indications

No indication recorded.