Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00548

2 Trial Registration Date

2017-02-27

i Registration Status

Prospective

3 Secondary IDs

2016.617

4 Source(s) of Funding

Health and Medical Research Fund

5 Primary Sponsor

NA

6 Secondary Sponsor

NA

Function

Not Applicable

Please specify

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

i Name

WU, Waner

ii Address

Office 4, 1F, Block EF (special block), Prince of wales hospital, 30-32 Ngan Shing Street, Shatin, N.T.

iii Phone

35051764

iv Email

wanerwu@link.cuhk.edu.hk

v Affiliation

Department of Obstetric and Gynaecology

vi Country

Hong Kong

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

i Name

Professor Chan Yiu Leung, David

ii Address

1F, Block E (special block), Prince of wales hospital, 30-32 Ngan Shing Street, Shatin, N.T.

iii Phone

3505 1399

iv Email

drdcyl16@cuhk.edu.hk

v Affiliation

Department of Obstetric and Gynaecology

vi Country

Hong kong

9 Official Scientific Title of the Study

A randomized placebo controlled trial on effect of modified traditional Chinese medicine formula Wuzi Yanzong Pill on improving semen qualities in men with sub-optimal parameters

10 Public Title

A randomized placebo controlled trial on effect of modified traditional Chinese medicine formula Wuzi Yanzong Pill on improving semen qualities in men with sub-optimal parameters

i Public Title in Chinese 研究名稱

中國傳統醫藥五子衍宗丸對不佳精液質素影響的隨機對照研究

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?

2017-02-03

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2016.617-T

14 Medical Condition Being Studied

sub-optimal semen parameters

15 Intervention

i Types of intervention

Other

Please specify

traditional Chinese medication

ii Description/ name of Intervention/article

the individual concentrated herbal medicine granules prepared from standardized decoction methods using state-of-art concentration technologies in GMP standard will be obtained from PuraPharm International (H.K.) Ltd. The individual concentrated herbal medicine granules will be prepared in sachet form. The modified Wuzi Yanzong Pill (五子衍宗丸) will be composed of Lycii Fructus 枸杞子 2.4g, Rubi Fructus 覆盆子 3g, Cuscutae Chinensis Semen 菟絲子 2.4g, Rehmanniae Glutinosae Conquitae Radix 熟地黃 3g, Polygonati Rhizoma 黃精 3g, Cistanches Deserticolae Herba 肉蓯蓉 2g, Epimedii Herba 仙靈脾 2g, Plantaginis Semen 車前子 2g, and Cornus Cervi Colla 鹿角膠 1.6g, totally 21.4g divide into two doses per day. For oral administration, the sachets at designated daily dose are mixed to combine each Chinese medicine.

iii Dosage form of the intervention

Granules of herbal medicine in sachet form. taken by oral

iv Dosage of the intervention

two doses per day

v Duration of the intervention

3 months

vi Frequency of the intervention

two doses per day

16 Comparative Treatments

i Description/ name of comparative treatments

Placebo with no Chinese medicine nor any hormonal medications will be prepared under the same GMP standard by PuraPharm International (H.K.) Ltd. To preserve blinding, all preparations will be indistinguishable in appearance and favours.

ii Dosage form of the comparative treatments

Granules of placebo in sachet form. taken by oral

iii Dosage of the comparative treatments

two doses per day

iv Duration of the comparative treatments

3 months

v Frequency of the comparative treatments

two doses per day

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

- Patients with one or more sub-optimal semen paremeters (Not satisfying WHO reference values in motility, morphology, concentration and total sperm count (any one of them).

ii Exclusion Criteria

- male infertility due to one testicle had been removed, history of undescended testis, previous chemotherapy, testicular torsion

- Patients with azoospermia

- Patients with normal WHO (Version 5) in all parameters

iii Age Minimum

18

iv Age Maximum

70

v Gender

Male

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

randomized in two group

ii Nature of control

Placebo

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Other

Please specify

CTC is not needed

vi Study Objectives (Optional)

1. To investigate the therapeutic effect of modified Wuzi Yanzong Pill (五子衍宗丸) on semen quality and sperm functions. 2. To investigate the effect of modified Wuzi Yanzong Pill (五子衍宗丸) on androgens/hormonal and other seminal biomolecules in the semen. 3. To investigate the impact of modified Wuzi Yan

20 Anticipated trial start date

2017-03-03

21 Target Sample Size

362

22 Recruitment Status

Complete

23 Primary Outcome

i The Name of the outcome

- Does WYP improve semen quality in patient with abnormal semen parameters? Are overall parameters improved?

ii The metric or method of measurement used

semen analysis

iii The timepoint(s) of primary interest

before TCM/ placebo taken, after 6 weeks and 3 months of taking TCM/ placebo

24 Secondary Outcome

i The Name of the outcome

- Does modified WYP alter FSH and free androgen index in men with suboptimal semen parameters?

ii The metric or method of measurement used

blood taking for hormonal test or other biochemical molecules

iii The timepoint(s) of primary interest

before and after TCM/ placebo taken

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2023-08-07

27 Primary Registry and Trial Identifying Number

ChiCTR-INR-17010790

28 Date of Registration in Primary Registry

2017-02-27

Back History

Trial Detail