Combination of CXD and Restrictive Ketogenic Diet Against MASLD
2026年7月10日 更新者：Shanghai Municipal Hospital of Traditional Chinese Medicine
Clinical Trial Study on the Combination of CXD and Restrictive Ketogenic Diet in Treating MASLD
This study employed a single-center, randomized, investigator-blind, three-group parallel, stepwise controlled clinical trial.
A total of 135 subjects were randomly assigned to receive either a low-carbohydrate diet intervention, a restrictive ketogenic diet intervention, or a decoction preparation of the Tucha Lipid-Reducing Formula combined with a restrictive ketogenic diet.
The trial duration consisted of 8 weeks of treatment followed by 8 weeks of follow-up.
During the trial, participants adhered to dietary calorie control and moderate exercise as instructed in health education, self-reported their height, weight, waist-to-hip ratio, and other general parameters, and had weekly blood ketone level monitoring.
Liver ultrasound, fasting blood glucose, lipid profiles, blood ketones, liver function tests, serum creatinine, urea nitrogen levels, and scores on the Traditional Chinese Medicine Syndrome Scale were measured before treatment initiation and at the end of the 8-week treatment period.
調査の概要
状態
まだ募集していません
研究の種類
介入
入学 (推定)
135
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：li xing wu
- 電話番号：86 15856953935
- メール：wuxingliwxl@126.com
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Age 18-50 years, regardless of gender
- Meet the diagnostic criteria for MASLD
- Meet the diagnostic criteria for dampness-heat accumulation syndrome in Traditional Chinese Medicine
- Liver controlled attenuation parameter (CAP) ≥238 dB/m
- Body mass index (BMI) ≥23 kg/m²
- Possess adequate cognitive and comprehension abilities to understand the study content, its potential risks, and benefits;
- Voluntarily participate in this study and personally sign the informed consent form
Exclusion Criteria:
- Concurrent presence of other liver diseases that may lead to hepatic steatosis, specifically including drug-induced liver injury, alcoholic liver disease, autoimmune liver disease, viral hepatitis, and Wilson's disease
- Concurrent severe dysfunction of major organs such as the heart, kidneys, or lungs, e.g., severe cardiac insufficiency (NYHA class III or higher), renal failure (estimated glomerular filtration rate <30 mL/min/1.73 m²), or acute exacerbation of chronic obstructive pulmonary disease
- Subjects currently receiving treatment for MASLD
- Concurrent presence of other severe systemic diseases, such as malignant tumors or active systemic lupus erythematosus
- Known hypersensitivity or intolerance to any component of the study drug
- Pregnant women, lactating women, or women of childbearing age who refuse effective contraceptive measures during the trial
- Participation in other clinical trials within the past 3 months
- Other circumstances deemed by the investigator unsuitable for participation in this study, such as severe mental disorders affecting compliance with the study
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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プラセボコンパレーター：Low-carbon control group
|
The control group received a standardized low-carbohydrate diet (carbohydrates accounted for 25%-30% of total caloric intake).
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実験的：KD group
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Daily carbohydrate intake should not exceed 5%, with three consecutive ketogenic days per week implemented (selected according to the subject's preference).
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実験的：CXD and KD group
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In addition to a restrictive ketogenic diet intervention, the patients were administered a traditional Chinese medicine compound formula named Chazhu Xiaoli Formula for lipid reduction.
Below is the composition of Chazhu Xiaozhi decoction: Camellia Sinensis Radix 15g, Atractylodis Rhizoma 15g, Herba Gynostemmatis Pentaphylli 15g, Ilicis Cornutae Folium 15g, Alismatis Rhizoma 9g, Nelumbinis Folium 6g, Crataegi Fructus 6g, Polygoni Orientalis Fructus 3g.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Controlled Attenuation Parameter (CAP) value
時間枠：From enrollment to the end of treatment at 8 weeks
|
Use an elastography ultrasound device to measure liver fat content
|
From enrollment to the end of treatment at 8 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
BMI
時間枠：From baseline to the end of the 8-week follow-up period
|
From baseline to the end of the 8-week follow-up period
|
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Triglyceride(TG)
時間枠：From enrollment to the end of treatment at 8 weeks
|
Use a fully automated biochemical analyzer to measure TG
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From enrollment to the end of treatment at 8 weeks
|
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Total blood cholesterol(TC)
時間枠：From enrollment to the end of treatment at 8 weeks
|
Use a fully automated biochemical analyzer to measure TC
|
From enrollment to the end of treatment at 8 weeks
|
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High-Density Lipoprotein(HDL)
時間枠：From enrollment to the end of treatment at 8 weeks
|
Use a fully automated biochemical analyzer to measure HDL
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From enrollment to the end of treatment at 8 weeks
|
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Alanine Aminotransferase (ALT)
時間枠：From enrollment to the end of treatment at 8 weeks
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Use a fully automated biochemical analyzer to measure liver function
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From enrollment to the end of treatment at 8 weeks
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Aspartate Aminotransferase(AST)
時間枠：From enrollment to the end of treatment at 8 weeks
|
Use a fully automated biochemical analyzer to measure liver function
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From enrollment to the end of treatment at 8 weeks
|
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Gamma-Glutamyl Transferase(GGT)
時間枠：From enrollment to the end of treatment at 8 weeks
|
Use a fully automated biochemical analyzer to measure liver function
|
From enrollment to the end of treatment at 8 weeks
|
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Blood glucose metabolism indicators
時間枠：From enrollment to the end of treatment at 8 weeks
|
Use a fully automated biochemical analyzer to measure blood glucose
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From enrollment to the end of treatment at 8 weeks
|
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Traditional Chinese Medicine Syndrome Scoring System
時間枠：From enrollment to the end of treatment at 8 weeks
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The title is Traditional Chinese Medicine Syndrome Scale.
The minimum score is 0 and the maximum is 6.
Lower scores indicate better results.
|
From enrollment to the end of treatment at 8 weeks
|
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Blood ketones
時間枠：From baseline to the end of the 8-week follow-up period
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Use a fully automated biochemical analyzer to measure blood ketones to indicate clinical safety
|
From baseline to the end of the 8-week follow-up period
|
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Creatinine
時間枠：From enrollment to the end of treatment at 8 weeks
|
Use a fully automated biochemical analyzer to measure creatinine to indicate clinical safety
|
From enrollment to the end of treatment at 8 weeks
|
|
Blood Urea Nitrogen
時間枠：From enrollment to the end of treatment at 8 weeks
|
Use a fully automated biochemical analyzer to measure blood urea nitrogen to indicate clinical safety
|
From enrollment to the end of treatment at 8 weeks
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年7月1日
一次修了 (推定)
2026年12月28日
研究の完了 (推定)
2027年2月1日
試験登録日
最初に提出
2026年5月27日
QC基準を満たした最初の提出物
2026年6月6日
最初の投稿 (実際)
2026年6月10日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月14日
QC基準を満たした最後の更新が送信されました
2026年7月10日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- KD20260527
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いいえ
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