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Chronic Kidney DiseasePhase 4NCT02231138

Efficacy and Safety of Abelmoschus Manihot for Chronic Kidney Disease

A Phase 4 study testing Abelmoschus manihot (AM) in people with Chronic Kidney Disease, run by Chinese PLA General Hospital at 78 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Huangkui Capsule is a single medicament of traditional Chinese medicine consists of Abelmoschus manihot and has been widely used to treat kidney disease. The purpose of this study is to evaluate the safety and efficacy of Abelmoschus manihot for treating chronic kidney disease in large scale samples with long time… Read more about this study

Who is it for?
Any age
Conditions the study is for
Chronic Kidney Disease
What is being tested?
Abelmoschus manihot (AM)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,600 participants
Where
78 sitesChina
Study dates
Sep 2014to Dec 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Clinical diagnosed as non-ESRD chronic kidney disease (stage I-IV)
  • Blood pressure of ≤140/90mmHg
  • Obtaining the signed informed consent from patients

Who cannot join

  • Be allergic to Huangkui Capsule
  • Combined with severe primary diseases of heart, brain, liver and hematopoietic system and so on, or other serious diseases which can affect the patient's life
  • Lactation, pregnancy or plans pregnancy during the study period
  • Participating in another clinical study in the same period

Trial locations and contacts

78 sites in 1 country.

78 sites in 1 country

China78 sites

  • The First Affiliated Hospital of Baotou Medical College

    Baotou, Inner Mongolia, 014000

  • Beijing Military General Hospital

    Beijing, Beijing Municipality, 100000

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100000

  • Dong Zhi Men Hospital of Beijing University of Chinese Medicine

    Beijing, Beijing Municipality, 100000

  • PLA Air Force General Hospital

    Beijing, Beijing Municipality, 100000

  • PLA Navy General Hospital

    Beijing, Beijing Municipality, 100000

  • The First Affiliated Hospital of General Hospital of PLA

    Beijing, Beijing Municipality, 100000

  • The Second Artillery General Hospital Of Chinese People's Liberation Army

    Beijing, Beijing Municipality, 100000

  • The Second Hospital Of Jilin University

    Changchun, Jilin, 130000

  • The Second Xiang Ya Hospital of Central South University

    Changsha, Hunan, 410000

  • Xiang Ya Hospital Central South University

    Changsha, Hunan, 410000

  • Affiliated Hospital of Cheng De Medical College

    Chengde, Hebei, 067000

  • Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

    Chengdu, Sichuan, 610000

  • The third People's Hospital of Chengdu

    Chengdu, Sichuan, 610000

  • Xin Qiao Hospital Of Third Military Medical University

    Chongqing, Chongqing Municipality, 400000

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning, 116000

  • The Second Hospital Of Dalian Medical University

    Dalian, Liaoning, 116000

  • Affiliated Hospital of Guilin Medical University

    Guilin, Guangxi, 541000

  • Affiliated Hospital of Guiyang Medical College

    Guiyang, Guizhou, 550000

  • Guizhou Province Hospital of Traditional Chinese Medicine

    Guiyang, Guizhou, 550000

  • The Affiliated Baiyun Hospital of Guizhou Medical University

    Guiyang, Guizhou, 550000

  • Heilongjiang Provincial Academy of Traditional Chinese Medicine

    Haerbin, Heilongjiang, 150000

  • The First Affiliated Hospital Of Heilongjiang University of Chinese Medicine

    Haerbin, Heilongjiang, 150000

  • Hainan Medical College Affiliated Hospital

    Haikou, Hainan, 570100

  • Hainan Provincial Nong Ken Hospital

    Haikou, Hainan, 570100

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, 310000

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui, 230000

  • Huang Gang Central Hospital

    Huanggang, Hubei, 438000

  • Jinan General Hospital of PLA

    Jinan, Shandong, 250000

  • Qi Lu Hospital of Shandong University

    Jinan, Shandong, 250000

  • Jining No.1 People's Hospital

    Jining, Shandong, 272000

  • First Affiliated Hospital of Liaoning Medical University

    Jinzhou, Liaoning, 121000

  • The Second Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650000

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu, 730000

  • The Second Hospital of Lanzhou University

    Lanzhou, Gansu, 730000

  • The First Affiliated Hospital of Henan University of Science And Technology

    Luoyang, Henan, 471000

  • Chinese People's Liberation Army No.94 Hospital

    Nanchang, Jiangxi, 330000

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi, 330000

  • The First Affiliated Hospital Of Nanchang University

    Nanchang, Jiangxi, 330000

  • Jiangsu Province Hospital of Traditional Chinese Medicine

    Nanjing, Jiangsu, 210000

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530000

  • The First Affiliated Hospital of Guangxi University of Chinese Medicine

    Nanning, Guangxi, 530000

  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu, 226000

  • Jiangxi Pingxiang People's Hospital

    Pingxiang, Jiangxi, 337000

  • First Hospital of Qinhuangdao

    Qinhuangdao, Hebei, 066000

  • Chinese People's Liberation Army No.180 Hospital

    Quanzhou, Fujian, 362008

  • Chang Hai Hospital of the Second Military Medical University

    Shanghai, Shanghai Municipality, 200000

  • Children's Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200000

  • Ren Ji Hospital of Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200000

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200000

  • Shanghai Ninth People's Hospital Affiliated Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200000

  • Shanghai Sixth People's Hospital Affiliated Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200000

  • Shu Guang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

    Shanghai, Shanghai Municipality, 200000

  • The General Hospital Of Shenyang Military Region

    Shenyang, Liaoning, 110000

  • The First Hospital of Shi He Zi Medical University

    Shihezi, Xinjiang, 832000

  • Chinese People's Liberation Army No.88 Hospital

    Taian, Shandong, 271000

  • Shanxi Hospital of Integrated Traditional And Western Medicine

    Taiyuan, Shanxi, 030000

  • Shanxi Provincial People's Hospital

    Taiyuan, Shanxi, 030000

  • The First Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030000

  • The Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030000

  • Jiangsu Taizhou People's Hospital

    Taizhou, Jiangsu, 225300

  • Taizhou Traditional Chinese Medicine Hospital

    Taizhou, Jiangsu, 225300

  • First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

    Tianjin, Tianjin Municipality, 300000

  • The Second Hospital Of Tianjin Medical University

    Tianjin, Tianjin Municipality, 300000

  • Tianjin Hospital of ITCWM, Nankai Hospital

    Tianjin, Tianjin Municipality, 300000

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

  • Hubei Provincial Hospital Of TCM

    Wuhan, Hubei, 430000

  • Union Hospital Tong Ji Medical College Hua Zhong University Of Science And Technology

    Wuhan, Hubei, 430000

  • Wuhan Integrated TCM & Western Medicine Hospital

    Wuhan, Hubei, 430000

  • Chinese People's Liberation Army No.174 Hospital

    Xiamen, Fujian, 361001

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan, 453000

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu, 221000

  • Yantai Yu Huang Ding Hospital

    Yantai, Shandong, 264000

  • Ningxia Hui Autonomous Region's Hospital

    Yinchuan, Ningxia, 750000

  • Zaozhuang Municipal Hospital

    Zaozhuang, Shandong, 277100

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 450000

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450000

  • Affiliated Hospital of Zun Yi Medical College

    Zunyi, Guizhou, 563000

Other trials in China

About this study

Official title: Efficacy and Safety of Abelmoschus Manihot for Chronic Kidney Disease：a Multicentre Open Study

Huangkui Capsule is a single medicament of traditional Chinese medicine consists of Abelmoschus manihot and has been widely used to treat kidney disease. The purpose of this study is to evaluate the safety and efficacy of Abelmoschus manihot for treating chronic kidney disease in large scale samples with long time take.

Read the detailed description

The test has not been completed.

Being tested
Abelmoschus manihot (AM)
Keywords
Abelmoschus manihot, Chronic Kidney Disease, proteinuria, efficacy, safety
Medical subject headings
Renal Insufficiency, Chronic, Proteinuria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abelmoschus manihot (AM)Drug

    Also called Huanghui capsule

    Abelmoschus manihot (AM): Huanghui capsule (Jiangsu Suzhong Pharmaceutical Group Co., Ltd.), 0.5 g × 30 capsules/box. A huangkui capsule is a single plant drug extract of Flos Abelmoschus manihot.

Study groups in NCT02231138
Study groupRoleWhat they receive
Abelmoschus manihot (AM)Experimental* age above 12 years old (including 12)：huangkui capsule are given orally at 2.5 g three times per day * age between 6-12 years old(including 6):huangkui capsule are given orally at 1.5 g three times per day * age under 6 years old：huangkui capsule are given orally at 1.0 g three times per day
Receives: Drug: Abelmoschus manihot (AM)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in 24-h proteinuria from baseline after treatment

    Measured: Baseline(week 0), week 12, week 24

Secondary outcomes (2)

  1. change in the serum creatinine level from baseline after treatment

    Measured: Baseline(week 0), week 12, week 24

  2. change in the estimated glomerular filtration rate (eGFR) from baseline after treatment

    Measured: Baseline(week 0), week 12, week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionJan 2016
  4. Study completionDec 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02231138
Sponsor's protocol ID
S2014-040-01
Status last verified
May 2016
First submitted
30 Aug 2014
Last updated
1 Jun 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: The test has not been completed.

Publications

  • Zhang L, Li P, Xing CY, Zhao JY, He YN, Wang JQ, Wu XF, Liu ZS, Zhang AP, Lin HL, Ding XQ, Yin AP, Yuan FH, Fu P, Hao L, Miao LN, Xie RJ, Wang R, Zhou CH, Guan GJ, Hu Z, Lin S, Chang M, Zhang M, He LQ, Mei CL, Wang L, Chen X. Efficacy and safety of Abelmoschus manihot for primary glomerular disease: a prospective, multicenter randomized controlled clinical trial. Am J Kidney Dis. 2014 Jul;64(1):57-65. doi: 10.1053/j.ajkd.2014.01.431. Epub 2014 Mar 14.

    PubMed 24631042

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Abelmoschus manihot (AM) in people with Chronic Kidney Disease, run by Chinese PLA General Hospital at 78 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in 24-h proteinuria from baseline after treatment (time frame: Baseline(week 0), week 12, week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02231138, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2016.

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