Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:53 AM
Study NCT ID:
NCT07360002
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-22
First Post:
2026-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Randomized Controlled Study of Shenqi Yishen Granules in the Treatment of IgA Nephropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005922', 'term': 'Glomerulonephritis, IGA'}], 'ancestors': [{'id': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D009393', 'term': 'Nephritis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077405', 'term': 'Irbesartan'}], 'ancestors': [{'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013141', 'term': 'Spiro Compounds'}, {'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 102}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-14', 'studyFirstSubmitDate': '2026-01-05', 'studyFirstSubmitQcDate': '2026-01-14', 'lastUpdatePostDateStruct': {'date': '2026-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Concentration of Potassium', 'timeFrame': '0 weeks, 4 weeks, 8 weeks, 12 weeks', 'description': 'Safety indicators'}, {'measure': 'electrocardiogram', 'timeFrame': '0 weeks, 4 weeks, 8 weeks, 12 weeks', 'description': 'Determine whether the patient has experienced adverse cardiac events based on the electrocardiogram'}, {'measure': 'Concentration of Alanine Aminotransferase', 'timeFrame': '0 weeks, 4 weeks, 8 weeks, 12 weeks', 'description': 'Safety indicators'}, {'measure': 'Concentration of Glutamic-oxaloacetic transaminase', 'timeFrame': '0 weeks, 4 weeks, 8 weeks, 12 weeks', 'description': 'Security indicators'}, {'measure': 'Concentration of hemoglobin', 'timeFrame': '0 weeks, 4weeks, 8 weeks, 12 weeks', 'description': 'Security indicators'}], 'primaryOutcomes': [{'measure': '24-hour urinary protein quantification', 'timeFrame': '0 weeks, 4 weeks, 8 weeks, 12 weeks', 'description': '24-hour urinary protein quantification'}, {'measure': 'Protein-to-creatinine rati', 'timeFrame': '0 weeks, 4 weeks, 8 weeks, 12 weeks', 'description': 'Concentration of Protein-to-creatinine rati'}], 'secondaryOutcomes': [{'measure': 'Red blood cells in urine', 'timeFrame': '0 weeks, 4 weeks, 8 weeks, 12 weeks', 'description': 'Red blood cells in urine'}, {'measure': 'Glomerular filtration rate', 'timeFrame': '0 weeks, 4 weeks, 8 weeks, 12 weeks', 'description': 'Glomerular filtration rate'}, {'measure': 'The number of infections in the respiratory, gastrointestinal, or urinary tract', 'timeFrame': '0 weeks, 4 weeks, 8 weeks, 12 weeks', 'description': 'The number of infections in the respiratory, gastrointestinal, or urinary tract'}, {'measure': 'TCM syndrome score', 'timeFrame': '0 weeks, 4 weeks, 8 weeks, 12 weeks', 'description': "Assess the patient's clinical symptoms based on the rating scale; the higher the score, the more severe the symptoms."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['IgA Nephropathy (IgAN)']}, 'descriptionModule': {'briefSummary': '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:\n\nDoes 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Meets the diagnostic criteria for IgA nephropathy and CKD stages 1-2, 24h-HPro \\> 0.3g;\n2. Meets the diagnostic criteria for "qi and yin deficiency syndrome" according to Traditional Chinese Medicine;\n3. Age between 18 and 75 years, gender;\n4. Infection, acidosis, electrolyte imbalance, hypertension, etc., are well controlled;\n5. No failure of other organ functions;\n6. 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.\n\nExclusion Criteria:\n\n* (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.'}, 'identificationModule': {'nctId': 'NCT07360002', 'briefTitle': 'The Randomized Controlled Study of Shenqi Yishen Granules in the Treatment of IgA Nephropathy', 'organization': {'class': 'OTHER', 'fullName': 'The Third Affiliated hospital of Zhejiang Chinese Medical University'}, 'officialTitle': 'The Randomized Controlled Study of Shenqi Yishen Granules in the Treatment of IgA Nephropathy', 'orgStudyIdInfo': {'id': 'ZSLL-KY-2025-129-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': 'Shenqi Yishen Granules + Irbesartan', 'interventionNames': ['Drug: Shenqi Yishen Granules']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'Chinese herbal placebo + Irbesartan', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Shenqi Yishen Granules', 'type': 'DRUG', 'otherNames': ['Irbesartan'], 'description': 'A traditional Chinese medicine compound for the treatment of IgA nephropathy', 'armGroupLabels': ['Treatment group']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Irbesartan'], 'description': 'a look-alike substance that contains no drug', 'armGroupLabels': ['Control Group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data involves the personal privacy of participants and should not be made public or shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Keda Lu', 'class': 'OTHER'}, 'collaborators': [{'name': 'The First Affiliated Hospital of Zhejiang Chinese Medical University', 'class': 'OTHER'}, {'name': 'The Second Affiliated Hospital of Zhejiang Chinese Medical University', 'class': 'OTHER'}, {'name': 'Red Cross Hospital, Hangzhou, China', 'class': 'OTHER'}, {'name': 'Hangzhou Traditional Chinese Medicine Hospital', 'class': 'UNKNOWN'}, {'name': 'Zhenhai District Traditional Chinese Medicine Hospital', 'class': 'UNKNOWN'}, {'name': 'Jiangsu Provincial Hospital of Traditional Chinese Medicine', 'class': 'UNKNOWN'}, {'name': 'Shao Yifu Hospital of Zhejiang Medical University', 'class': 'UNKNOWN'}, {'name': "Hangzhou First People's Hospital, School of Medicine, Zhejiang Universiry", 'class': 'UNKNOWN'}, {'name': 'Yuyao City Traditional Chinese Medicine Hospital', 'class': 'UNKNOWN'}, {'name': 'First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine', 'class': 'UNKNOWN'}, {'name': 'Affiliated Hospital of Jiaxing University', 'class': 'OTHER'}, {'name': "Hangzhou Xiaoshan First People's Hospital", 'class': 'UNKNOWN'}, {'name': "Shanghai 6th People's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Keda Lu', 'investigatorAffiliation': 'The Third Affiliated hospital of Zhejiang Chinese Medical University'}}}}