[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641084":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":36,"responsibleParty":43,"collaborators":45,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":18,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":18,"enrollmentInfo":56,"targetDuration":18,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":69,"whyStopped":18,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"China Medical University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"DKD-1 plus standard therapy","EXPERIMENTAL","Participants receive DKD-1 (14.5 g\u002Fday) orally in addition to standard care for 12 weeks. Standard care includes guideline-based management of blood glucose, blood pressure, and kidney protection therapy, which remains stable throughout the study period. DKD-1 consists of Astragalus 3.0 g, Salvia miltiorrhiza 2.5 g, Chinese yam 2.5 g, Poria 2.0 g, Moutan cortex 1.5 g, Schisandra 1.0 g, and Smilax glabra 2.0 g as concentrated herbal granules. Participants in the control group receive standard care alone without DKD-1 supplementation.",[13],"Other: Chinese herbal formula DKD-1",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard therapy alone","NO_INTERVENTION","Participants receive standard care alone for 12 weeks. Standard care includes guideline-based management of blood glucose, blood pressure, and kidney protection therapy, maintained without addition of DKD-1 during the study period.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"Chinese herbal formula DKD-1","DKD-1 is a traditional Chinese herbal formula administered orally at a total daily dose of 14.5 g for 12 weeks. The formula consists of Astragalus membranaceus (3.0 g), Salvia miltiorrhiza (2.5 g), Chinese yam (2.5 g), Poria cocos (2.0 g), Moutan cortex (1.5 g), Schisandra chinensis (1.0 g), and Smilax glabra (2.0 g). It is used as an adjunct to standard care in patients with diabetic kidney disease.",[9],[25],{"name":26,"affiliation":27,"role":28},"Ing-Shiow Lai, MD, PhD","China Medical University Beigang Hospital","STUDY_DIRECTOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},"CHE-JU CHANG, MD","CONTACT","+886-5-7837901","1229","160076@tool.caaumed.org.tw",[37],{"facility":27,"status":18,"city":38,"state":39,"zip":18,"country":39,"countryCode":40,"cosmosGeoPoint":18,"geoPoint":18,"contacts":41},"Yunlin","Taiwan","TW",[42],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},{"type":44,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[46],{"name":27,"class":6},"100641084","effect-of-chinese-herbal-medicine-on-renal-function-in-diabetic-kidney-disease-100641084",false,"NCT07657351","Effect of Chinese Herbal Medicine on Renal Function in Diabetic Kidney Disease","Effects of Chinese Herbal Medicine as an Adjunctive Therapy on Renal Function in Patients With Diabetic Kidney Disease: A Pilot Randomized Controlled Trial","Inclusion Criteria:\n\n* Adults aged ≥18 years.\n* Patients diagnosed with type 2 diabetes mellitus and stage 3-4 chronic kidney disease (CKD), confirmed by a nephrologist and classified as ICD-10-CM codes E11.21-E11.29 combined with N18.3-N18.4, consistent with diabetic kidney disease (DKD) definitions.\n* Ability to understand the study procedures and provide written informed consent.\n* Willingness to comply with study procedures and follow-up visits.\n\nExclusion Criteria:\n\n* Acute kidney injury or major kidney-related surgery within 3 months prior to enrollment.\n* Participation in another clinical trial within 3 months that may significantly affect renal function.\n* Alanine aminotransferase (ALT) levels greater than 3 times the upper limit of normal.\n* Pregnancy or breastfeeding.\n* History of malignancy currently receiving chemotherapy, radiotherapy, or other systemic anticancer treatment.\n* End-stage disease as defined under palliative care regulations.\n* Known allergy to any components of the DKD-1 herbal formula, including Astragalus membranaceus, Salvia miltiorrhiza, Chinese yam, Poria cocos, Moutan cortex, Schisandra chinensis, or Smilax glabra.","ALL","18 Years",{"count":57,"type":58},66,"ESTIMATED","INTERVENTIONAL",[61],"NA","This study is a randomized controlled pilot trial designed to evaluate the effects and safety of a traditional Chinese medicine formula (DKD-1) as an add-on therapy to standard treatment in patients with Diabetic Kidney Disease (DKD). Eligible participants will be randomly assigned to receive either standard care alone or standard care combined with DKD-1 for 12 weeks. Kidney function, glycemic control, proteinuria, quality of life, and traditional Chinese medicine tongue features will be assessed before and after the intervention. The study aims to provide preliminary evidence on whether DKD-1 can improve renal function, glycemic control, and quality of life in this patient population.",[64],"Diabetic Kidney Disease",[66,64,67,68],"Traditional Chinese Medicine","Adjunctive Therapy","Pilot Randomized Controlled Trial","NOT_YET_RECRUITING","2026-06-15",{"date":72,"type":73},"2026-06-18","ACTUAL",{"date":75,"type":58},"2026-06-11",{"date":77,"type":58},"2026-12-31",{"name":5,"class":6},1]