Efficacy and Safety of Abelmoschus Manihot for Chronic Kidney Disease

Overview

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.

Full Title of Study: “Efficacy and Safety of Abelmoschus Manihot for Chronic Kidney Disease:a Multicentre Open Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2016

Detailed Description

The test has not been completed.

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Change in 24-h proteinuria from baseline after treatment
    • Time Frame: Baseline(week 0), week 12, week 24

Secondary Measures

  • change in the serum creatinine level from baseline after treatment
    • Time Frame: Baseline(week 0), week 12, week 24
  • change in the estimated glomerular filtration rate (eGFR) from baseline after treatment
    • Time Frame: Baseline(week 0), week 12, week 24

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chinese PLA General Hospital
  • Collaborator
    • Jiangsu Suzhong Pharmaceutical Group Co., Ltd.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Xiangmei Chen, professsor – Chinese PLA General Hospital
  • Overall Official(s)
    • Xiangmei Chen, MD.& Ph.D, Principal Investigator, Chinese PLA General Hospital

References

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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.