Evaluation of clinical efficacy of Modified Huangqi Chifeng Decoction in treating IgA Nephropathy proteinuia based on Chinese medicine pathogenesis of “deficiency-wind-stasis -toxin”

• Register: ChiCTR
• Last refreshed on: 16 November 2020
• Main ID: ChiCTR1900022100
• Date of registration: 2019-03-25
• Prospective Registration: Yes
• Primary sponsor: Xiyuan Hospital, China Academy of Chinese Medical Sciences
• Public title: Evaluation of clinical efficacy of Modified Huangqi Chifeng Decoction in treating IgA Nephropathy proteinuia based on Chinese medicine pathogenesis of “deficiency-wind-stasis -toxin”
• Scientific title: Evaluation of clinical efficacy of Modified Huangqi Chifeng Decoction in treating IgA Nephropathy proteinuia based on Chinese medicine pathogenesis of “deficiency-wind-stasis -toxin”
• Date of first enrolment: 2019-04-01
• Target sample size: Placebo Group:40;Experimental group:40;
• Recruitment status: Recruiting
• URL: http://www.chictr.org.cn/showproj.aspx?proj=31781
• Study type: Interventional study
• Study design: Parallel
• Phase: N/A

Countries of recruitment

China

Contacts

• Name: Chang Meiying
• Affiliation: Xiyuan Hospital, China Academy of Chinese Medical Sciences

• Name: Zhang Yu
• Affiliation: Xiyuan Hospital, China Academy of Chinese Medical Sciences

Key inclusion & exclusion criteria

Inclusion criteria: ? The diagnosis was IgA nephropathy, and the pathologic reports of renal perforation were reported in all cases.
? No gender limitation, aged 18-70 years.
? Moderate proteinuria(24-hour urinary protein quantity is between 1.0-2.5g)accompanied or not accompanied by microscopic hematuria.
? CKD1-2(GFR=60ml/min/1.73m2).
? TCM syndrome differentiation accords with qi deficiency and blood stasis syndrome as well as wind pathogen and heat toxicity.
? Non-dialysis patients with infection, acidosis, electrolyte disturbance, hypertension and other aggravating factors are effectively controlled and the condition is stable. The BP is between 130-90/80-60mmHg. Potassium is in the normal range.
? Voluntarily accept this study and sign the informed consent form.
Exclusion criteria: ? Secondary factors leading to proteinuria, such as purpura nephritis, lupus nephritis.
? Patients who have been treated by glucocorticoid, immunosuppressant, tripterygium wilfordii preparation in three months are not included.
? Having mental illness, infectious disease or pregnancy.
? Patients who have chronic liver disease, myocardial fibrosis or interstitial pulmonary fibrosis are not included. ? Patients with acute renal failure or after renal transplantation are not included.
? Participants who are participating in other interventional clinical trials.

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

IgA nephropathy

Intervention(s)

Placebo Group:Placebo+telmisartan;Experimental group:Flavoured huangqi chifeng granules+telmisartan;

Primary Outcome(s)

Urine protein quantitation for 24 hours;Urine protein/creatinine;Routine urine;

Secondary Outcome(s)

TCM symptom score;Serum IgA/C3;Serum SIgA;Serum creatinine;

Source(s) of Monetary Support

Beijing municipal commission of health and family planning

Ethics review

Status: Approved
Approval date: 14/01/2019
Contact:

Zi Mingjie

[phone]