Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00520

2 Trial Registration Date

2016-07-26

i Registration Status

Prospective

3 Secondary IDs

CREC2014.548-T

4 Source(s) of Funding

Institute of Chinese Medicine

5 Primary Sponsor

The Jockey Club School of Public Health and Primary Care

6 Secondary Sponsor

Institute of Chinese Medicine

Function

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

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Nicole Huang

ii Address

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

iii Phone

2252 8408

iv Email

nicolehuang@cuhk.edu.hk

v Affiliation

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

vi Country

Hong Kong

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Eliza Wong

ii Address

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

iii Phone

22528772

iv Email

lywong@cuhk.edu.hk

v Affiliation

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

vi Country

Hong Kong

9 Official Scientific Title of the Study

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

10 Public Title

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

i Public Title in Chinese 研究名稱

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

11 Short Title (Optional)

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2016-05-17

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

CREC 2014.548-T

14 Medical Condition Being Studied

Menopausal Women

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Danggui Buxue Tang (DBT)

iii Dosage form of the intervention

Sachet

iv Dosage of the intervention

6g

v Duration of the intervention

12 weeks

vi Frequency of the intervention

Daily

16 Comparative Treatments

i Description/ name of comparative treatments

NA

ii Dosage form of the comparative treatments

NA

iii Dosage of the comparative treatments

NA

iv Duration of the comparative treatments

NA

v Frequency of the comparative treatments

NA

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

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

ii Exclusion Criteria

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

iii Age Minimum

45

iv Age Maximum

60

v Gender

Female

18 Study Type

Interventional

19 Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Uncontrolled

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Single group

v Study Phase

2

Please specify

vi Study Objectives (Optional)

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

20 Anticipated trial start date

2016-08-29

21 Target Sample Size

50

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

Quality of Life questionnaire

ii The metric or method of measurement used

EQ-5D / Menopause-specific QOL

iii The timepoint(s) of primary interest

Week 0 / Week 8 / Week 12

24 Secondary Outcome

i The Name of the outcome

Laboratory testing

ii The metric or method of measurement used

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

iii The timepoint(s) of primary interest

Week 0 / Week 8 / Week 12

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2016-09-20

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

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Trial History Detail on 2016-07-26