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Trial History Detail on 2016-09-20

CUHK_CCRB00520

2016-07-26

Prospective

CREC2014.548-T

Institute of Chinese Medicine

The Jockey Club School of Public Health and Primary Care

Institute of Chinese Medicine

Form a group with the primary sponsor in which the responsibilities of sponsorship are allocated among the members of the group

Nicole Huang

The Jockey Club School of Public Health and Primary Care
Prince of Wales Hospital

2252 8408

nicolehuang@cuhk.edu.hk

The Jockey Club School of Public Health and Primary Care , The Chinese University of Hong Kong

Hong Kong

Eliza Wong

The Jockey Club School of Public Health and Primary Care
Prince of Wales Hospital

22528772

lywong@cuhk.edu.hk

The Jockey Club School of Public Health and Primary Care , The Chinese University of Hong Kong

Hong Kong

Change in health-related quality of life & immunity among menopausal women using Danggui Buxue Tang

Change in health-related quality of life & immunity among menopausal women using Danggui Buxue Tang

當歸補血湯對更年期婦女的生活素質及身體免疫健康研究

Hong Kong

Yes

2016-05-17

Joint CUHK-NTEC Clinical Research Ethics Committee

CREC 2014.548-T

Menopausal Women

Drug

Danggui Buxue Tang (DBT)

Sachet

6g

12 weeks

Daily

NA

NA

NA

NA

NA

Women aged 45-60 years who are in the postmenopausal with uterus in the past 12 months prior to study entry

No known thyroid dysfunction

No known positive mammogram finding within 2 years prior to study

Absence of the Risk of medical complications based on medical history

Use of alternative or complementary medicines or herbs for menopause symptoms in previous month

Pregnant or planning to become pregnant

Total oophorectomy

Herbal allergy

Current participation in other drug trial

Intention to move away HK within next 16 weeks

Unable to give consent

Use of hormone therapy or oral contraceptives within prior 3 months of study entry

receiving medical treatment for chronic disease

45

60

Female

Interventional

Non-randomized

Uncontrolled

Open label

Single group

2

Study the effect of Danggui Buxue Tang on the health-related quality of life and immunity among menopausal women

2016-08-29

50

Not Yet Recruiting

Quality of Life questionnaire

EQ-5D / Menopause-specific QOL

Week 0 / Week 8 / Week 12

Laboratory testing

Cytokine/chemokine plasma concentration and Total antioxidant capacity in the serum

Week 0 / Week 8 / Week 12

No

2016-09-20

ChiCTR-OOC-16008927

2016-07-26

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