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Effects of Niaoduqing Particles in preventing the progression of stage 3-4 chronic kidney disease: a multicenter, double-blind, randomized, placebo-controlled trial

A prospective, multi-Center, double-blind, randomized, placebo-controlled study to assess the safety andefficacy of Niaoduqing Particles in preventing the progression of stage 3-4 chronic kidney disease

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12002448
Enrollment
Unknown
Registered
2012-08-15
Start date
1990-01-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic kidney disease

Interventions

treated group:Taking Niaoduqing particles with warm boiled water, 1 bag, tid, 2 bags,qn
controlled group:Taking placebo with warm boild water,1 bag,tid, 2 bags, qn

Sponsors

Chinese General Hospital of PLA
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Male or female 18-70 years of age; 2. Patients with chronic kidney disease in stage 3-4 (GFR20-45ml/(ml/min/1.73m2)); 3. According to syndrome differentiation of Traditional Chinese Medicine (TCM) it belongs to damp filth anddeficient spleen or spleen deficiency andblood stasis; Standards for Syndrome Differentiation Typing of TCM; Primary Deficiency Syndrome: Both Spleen Qi andKidney Qi Deficiency Syndrome; The main symptoms: weakness, fatigue, lumbus andknees debility, cool andincreased nocturia; The minor symptoms: pale complexion, abdominal distension, anorexia, thin sloopy stool. (It could be diagnosed with more than two major symptoms, or a major symptom andtwo minor symptoms) The secondary excess syndrome: Damp Pathogen Syndrome: The main symptoms: nausea, vomiting, edema; The minor symptoms: greasy mouth, heavy sensation in limbs, sticky stools; Blood Stasis Syndrome: The main symptoms: fixed or stabbing pain of low back, dark purple mouth lips andtongue with ecchymosis or point. The minor symptoms: blackish complexion, coarse skins, Limb Numbness. (It could be diagnosed with the main symptoms of more than one or two minor symptoms) 4. Hypertension can be effectively controlled, blood pressure <=140/90mmHg; 5. Signed the informed consent form prior to the study participation.

Exclusion criteria

Exclusion criteria: Allergic constitution or allergic to multiple drugs; Nephritic syndrome, lupus nephritis andother autoimmune diseases; Previous treatment with Niaoduqing particles within one month; Previous treatment with herb or traditional Chinese patent medicines andsimple preparations which contains rhubarb or something affect renal function, activated carbon andadsorbent etc. in recent month or during the trial period; Previous treatment with glucocorticoid or immunosuppressive agents (including tripterygium glycosides tablet) within three months or during the trial period; Proposes to perform renal replacement; Infectious diseases, including urinary tract infections, non-infectious inflammatory disease or acute infection recently; Serious gastrointestinal disease which affect drug absorption, such as active ulcer, chronic diarrhea, post gastrointestinal surgery etc. Severe cardiovascular, brain, liver, or hematopoietic system disease. Acute urinary tract obstruction, need surgical treatment. Can not be partners, such as the mentally ill. Women in pregnancy or lactation; With alcohol or drug abuse; Enrolled in other trials; Any other conditions that researchers think not suitable for this experiment.

Design outcomes

Primary

MeasureTime frame
serum creatitine and eGFR;cystatin;

Secondary

MeasureTime frame
24h urinary protein excretion;urinary albumin/ urinary creatintine;biochemical indices of anemia;blood urea nitrogen;hs-CRP;MDA;Superoxide dismutase (SOD);urinary IL-6;urinary NGAL;

Countries

China

Contacts

Public ContactXiangmei Chen
xmchen301@126.com+86 10 66395462

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 4, 2026