Trials / Unknown
UnknownNCT04218487
Xuefu-Zhuyu Capsule for the Treatment of "Qizhi Xueyu Zheng" (Qi Stagnation and Blood Stasis Syndrome)
The Efficacy and Safety of Xuefu Zhuyu Capsule in Treating "Qizhi Xueyu Zheng" (Qi Stagnation and Blood Stasis Syndrome): a Randomized, Double-blind, Placebo-controlled, Adaptive Enrichment, Multicenter Controlled Trial
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 720 (estimated)
- Sponsor
- Zhong Wang · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
"Xuefu-Zhuyu capsule" (XFZY) is made from a classic Fangji "Xuefu-Zhuyu Decoction" in an ancient Chinese medical book "Yi Lin Gai Cuo" by Chinese physician Wang Qingren, which is the most representative formula for the treatment of "Qizhi-Xueyu Zheng" (Qi Stagnation and Blood Stasis Syndrome). XFZY concludes 11 kinds of Chinese herbs: Danggui(Angelica sinensis), Honghua(Safflower Flower), Chishao(Paeoniae Radix Rubra), Shengdihuang(Radix Rehmanniae), Taoren(Peach Seed), Zhike(Fructus Aurantii), Jugeng(Platycodon grandiflorum), Chuanxiong(Rhizome of Chuanxiong), Chaihu(Radix Bupleuri), Chuanniuxi(Cyathula Officinalis),Gancao(liquorice).It is mainly used to treat "Qizhi-Xueyu Zheng", which includes the symptoms such as different types of pain, irritability or depression, insomnia, chest tightness, dark skin, lumps or masses in vitro or in vivo, petechiae on the tongue, and dark purple tongue. The purpose of the trial is to evaluate the efficacy and safety of XFZY in treating "Qizhi-Xueyu Zheng", and investigate the most suitable diseases of XFZY.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Xuefu-Zhuyu Capsule | treatment with 2.4g (6 capsules) of XFZY three times daily for 12 weeks. |
| DRUG | placebo | treatment with 2.4g (6 capsules) of placebo three times daily for 12 weeks. |
| OTHER | conventional therapy | conventional therapy will be given according to the suffering diseases including stable coronary heart disease, chronic insomnia, headache, endometriosis. |
Timeline
- Start date
- 2019-12-31
- Primary completion
- 2023-12-31
- Completion
- 2024-06-30
- First posted
- 2020-01-06
- Last updated
- 2022-11-15
Locations
12 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04218487. Inclusion in this directory is not an endorsement.