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Trial Detail

CUHK_CCRB00548

2017-02-27

Prospective

2016.617

NA

NA

NA

Not Applicable

YIU Yun Sang, Sandy

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

35051764

sandyyiu@cuhk.edu.hk

Department of Obstetric and Gynaecology

Hong Kong

Professor Chung Pui Wah Jacqueline

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

3505 2800

jacquelinechung@cuhk.edu.hk

Department of Obstetric and Gynaecology

Hong kong

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

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

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

Hong Kong

Yes

2017-02-03

Joint CUHK-NTEC Clinical Research Ethics Committee

2016.617-T

sub-optimal semen parameters

Other

traditional Chinese medication

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.

Granules of herbal medicine in sachet form. taken by oral

two doses per day

3 months

two doses per day

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.

Granules of placebo in sachet form. taken by oral

two doses per day

3 months

two doses per day

- 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).

- 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

18

70

Male

Interventional

Randomized

randomized in two group

Placebo

Double-blind

Parallel

Other

CTC is not needed

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

2017-03-03

286

Recruiting

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

semen analysis

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

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

blood taking for hormonal test or other biochemical molecules

before and after TCM/ placebo taken

No

2021-07-23

ChiCTR-INR-17010790

2017-02-27

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