Peiyuan Guben Tongluo Ointment for Elderly Sarcopenia

Официальное название

A Randomized, Double-Blind Clinical Study of Peiyuan Guben Tongluo Ointment in the Treatment of Elderly Sarcopenia (Spleen-Kidney Deficiency Syndrome) With Two Internal and External Controls

Обзор

With the agarose concentrating group of Peiyuan Guben Tongluo Ointment set as the parallel control and an external control established simultaneously, this study aimed to evaluate the increases from baseline in DXA-measured limb muscle mass after 12 weeks of medication in elderly sarcopenia patients treated with the Ejiao concentrating group of Peiyuan Guben Tongluo Ointment.

Подробное описание

Overall Design: This study adopts a randomized, double-blind clinical trial design with both internal and external controls. Trial Flow: The trial consists of a screening/baseline period, a 12-week treatment administration period, and a 12-week follow-up period. The end-of-trial visit will be conducted at Week 24 after medication administration (EOS/EOT). Randomization and Blinding: Block randomization is applied in this study, with subjects randomized into each group at a 1:1 ratio under a double-blind design. Data Collection: Electronic Data Capture (EDC) system combined with patient diaries. External Control: External controls include published literature data and real-world study data.

Вмешательства

• Пищевая добавка nutritional intervention
  Provide protein and vitamin D supplementation.
• Поведенческое Exercise
  Receive standardized Baduanjin training with unified movements; the training is conducted 3 times weekly, starting 3 hours after meals, with a duration of 30 minutes per session.
• Препарат Peiyuan Guben Tongluo Ointment (Ejiao concentrated)
  Peiyuan Guben Tongluo Ointment (Ejiao concentrated): 20 g once daily, administered with warm water; Composition: Rehmanniae Radix Preparata 120 g, Rehmanniae Radix 120 g, Epimedii Folium 60 g, Achyranthis Bidentatae Radix 120 g, Eucommiae Cortex 60 g, Dipsaci Radix 90 g, Astragali Radix 150 g, Codonopsis Radix 150 g, Dioscoreae Rhizoma 150 g, Paeoniae Radix Alba (stir-fried) 120 g, Polygonati Odorati Rhizoma 100 g, Scrophulariae Radix 90 g, Ligustri Lucidi Fructus 100 g, Ecliptae Herba 100 g, Ci
• Препарат Peiyuan Guben Tongluo Ointment (Agarose concentrated)
  Peiyuan Guben Tongluo Ointment (Agarose concentrated): 20 g once daily, administered with warm water; Composition: Rehmanniae Radix Preparata 120 g, Rehmanniae Radix 120 g, Epimedii Folium 60 g, Achyranthis Bidentatae Radix 120 g, Eucommiae Cortex 60 g, Dipsaci Radix 90 g, Astragali Radix 150 g, Codonopsis Radix 150 g, Dioscoreae Rhizoma 150 g, Paeoniae Radix Alba (stir-fried) 120 g, Polygonati Odorati Rhizoma 100 g, Scrophulariae Radix 90 g, Ligustri Lucidi Fructus 100 g, Ecliptae Herba 100 g,

Первичные конечные точки

• DXA-measured appendicular skeletal muscle mass [Срок оценки: Baseline, week 12, week 24]

Вторичные конечные точки (11)

• Upper limb handgrip strength [Срок оценки: Up to 24 weeks]
• Handgrip strength [Срок оценки: Baseline, week 12, week 24]
• Timed Up and Go test (TUG) [Срок оценки: Baseline, week 12, week 24]
• Berg Balance Scale (BBS) [Срок оценки: Baseline, week 12, week 24]
• TCM Syndrome Score [Срок оценки: Baseline, week 12, week 24]
• Peripheral blood white blood cell count [Срок оценки: Baseline, week 12]
• Neutrophil count [Срок оценки: Baseline, week 12]
• Interleukin-2 [Срок оценки: Baseline, week 12]
• Interleukin-6 [Срок оценки: Baseline, week 12]
• Mini Nutritional Assessment (MNA) [Срок оценки: Baseline, week 12, week 24]
• Activities of Daily Living (ADL) Scale [Срок оценки: Baseline. week 12, week 24]

Критерии участия

Критерии включения

• Patients aged ≥ 60 years and ≤ 80 years, regardless of gender; ② Patients meeting the diagnostic criteria for sarcopenia in the elderly according to both traditional Chinese medicine (TCM) and Western medicine;

• Patients meeting the TCM diagnostic criteria for Spleen-Kidney Deficiency Syndrome;

• Able to take oral medications, willing to comply with the study intervention protocol, able to attend follow-up visits on time, and have signed the informed consent form.

Критерии исключения

• Patients with quadriplegia, long-term bedridden status, zero muscle strength due to severe cerebrovascular accident, muscle atrophy caused by various factors, or inability to perform activities of daily living;

• Patients with unclear consciousness, aphasia, delirium, inability to respond, or impaired time, location and orientation due to senile or vascular dementia;

• Patients with severe mental illness, depressive state, or receiving relevant psychotropic medication; ④ Patients complicated with tumors, severe infections, gastrointestinal bleeding, hepatic and renal insufficiency, cardiac insufficiency, or other diseases affecting nutritional status; ⑤ Patients with hypersensitivity to the study drugs; patients who have received or are receiving traditional Chinese medicine treatment within the past 1 month; patients who have received medications affecting muscle contraction/relaxation within the past 1 month.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Yueyang Integrated Medicine Hospital — Шанхай

Идентификаторы

NCT: NCT07538674 · YY-PYGBTLG-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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