The Randomized Controlled Study of Shenqi Yishen Granules in the Treatment of IgA Nephropathy

Обзор

The goal of this clinical trial is to learn if Shenqi Yishen Granules works to treat IgA Nephropathy in adults. It will also learn about the safety of Shenqi Yishen Granules. The main questions it aims to answer are: Does Shenqi Yishen Granules lower 24-hour urinary protein quantification of participants? What medical problems do participants have when taking Shenqi Yishen Granules? Researchers will compare Shenqi Yishen Granules to a placebo (a look-alike substance that contains no drug) to see if Shenqi Yishen Granules works to treat IgA Nephropathy.

Вмешательства

• Препарат Shenqi Yishen Granules
  A traditional Chinese medicine compound for the treatment of IgA nephropathy
• Препарат Placebo
  a look-alike substance that contains no drug

Первичные конечные точки

• 24-hour urinary protein quantification [Срок оценки: 0 weeks, 4 weeks, 8 weeks, 12 weeks]
• Protein-to-creatinine rati [Срок оценки: 0 weeks, 4 weeks, 8 weeks, 12 weeks]

Вторичные конечные точки (4)

• Red blood cells in urine [Срок оценки: 0 weeks, 4 weeks, 8 weeks, 12 weeks]
• Glomerular filtration rate [Срок оценки: 0 weeks, 4 weeks, 8 weeks, 12 weeks]
• The number of infections in the respiratory, gastrointestinal, or urinary tract [Срок оценки: 0 weeks, 4 weeks, 8 weeks, 12 weeks]
• TCM syndrome score [Срок оценки: 0 weeks, 4 weeks, 8 weeks, 12 weeks]

Критерии участия

Критерии включения

• Meets the diagnostic criteria for IgA nephropathy and CKD stages 1-2, 24h-HPro > 0.3g;
• Meets the diagnostic criteria for "qi and yin deficiency syndrome" according to Traditional Chinese Medicine;
• Age between 18 and 75 years, gender;
• Infection, acidosis, electrolyte imbalance, hypertension, etc., are well controlled;
• No failure of other organ functions;
• Have good compliance, have not participated in other clinical trials in the past six months; are informed and voluntarily willing to participate in the clinical study.

Критерии исключения

• (1) Immediate dialysis treatment is required; currently undergoing treatment with hormones, non-steroidal anti-inflammatory drugs, or immunosuppressive agents; (2) Patients with acute infectious diseases or those under surgical or traumatic stress; (3) Patients with chronic infectious diseases such as active chronic hepatitis B,, decompensated cirrhosis, or active tuberculosis; (4) Patients with severe organ dysfunction affecting survival, such as malignant tumors or HIV infection; (5) Patients with severe primary diseases of the cardiovascular, hematological, neurological, digestive, or respiratory systems, or those with a significant tendency to bleed; (6) Patients with life-threatening conditions such as hyperkalemia or heart failure; (7) Patients with a GFR fluctuation of ≥30% within the past 3 months; (8) Patients with severe allergies to certain known drugs in this study or unable to tolerate them; (9) Patients who are pregnant or breastfeeding; (10) Patients with a history of drug abuse or who have used immunosuppressive agents or glucocorticoids in the past 3 months; (11) Patients with major bleeding or blood transfusion history in the past 3 months, or those with severe clinical infections or signs of acidosis; (12) Patients currently participating in other clinical trials or undergoing other Chinese herbal treatments that may affect efficacy assessment; (13) Patients planning or having undergone kidney transplantation, or those with acute or chronic kidney failure requiring immediate replacement therapy; (14) Patients with post-renal factors, such as obstruction (including stones, uric acid crystals, or tumors) causing acute kidney injury; (15) Patients with a history of mental illness or communication/cognitive impairments leading to poor compliance and inability to cooperate; (16) Non-Asian individuals.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07360002 · ZSLL-KY-2025-129-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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