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Efficacy and Safety of Abelmoschus Manihot for Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT02231138
Recruitment Status : Unknown
Verified May 2016 by Xiangmei Chen, Chinese PLA General Hospital.
Recruitment status was:  Active, not recruiting
First Posted : September 4, 2014
Last Update Posted : June 1, 2016
Sponsor:
Collaborator:
Jiangsu Suzhong Pharmaceutical Group Co., Ltd.
Information provided by (Responsible Party):
Xiangmei Chen, Chinese PLA General Hospital

Brief 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 take.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: Abelmoschus manihot (AM) Phase 4

Detailed Description:
The test has not been completed.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1600 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Abelmoschus Manihot for Chronic Kidney Disease:a Multicentre Open Study
Study Start Date : September 2014
Actual Primary Completion Date : January 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Abelmoschus manihot (AM)
  • 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
Drug: Abelmoschus manihot (AM)
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.
Other Name: Huanghui capsule




Primary Outcome Measures :
  1. Change in 24-h proteinuria from baseline after treatment [ Time Frame: Baseline(week 0), week 12, week 24 ]

Secondary Outcome Measures :
  1. change in the serum creatinine level from baseline after treatment [ Time Frame: Baseline(week 0), week 12, week 24 ]
  2. change in the estimated glomerular filtration rate (eGFR) from baseline after treatment [ Time Frame: Baseline(week 0), week 12, week 24 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02231138


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Sponsors and Collaborators
Chinese PLA General Hospital
Jiangsu Suzhong Pharmaceutical Group Co., Ltd.
Investigators
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Principal Investigator: Xiangmei Chen, MD.& Ph.D Chinese PLA General Hospital

Publications:
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Responsible Party: Xiangmei Chen, professsor, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT02231138     History of Changes
Other Study ID Numbers: S2014-040-01
First Posted: September 4, 2014    Key Record Dates
Last Update Posted: June 1, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The test has not been completed.

Keywords provided by Xiangmei Chen, Chinese PLA General Hospital:
Abelmoschus manihot
Chronic Kidney Disease
proteinuria
efficacy
safety

Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency