A Phase 2 interventional study of Traditional Chinese Medicine Steam Bath in Post-Chemotherapy Peripheral Neuropathy, sponsored by Emeishan Hospital of Traditional Chinese Medicine. Completed at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Emeishan Hospital of Traditional Chinese Medicine · Phase 2, Interventional, and Treatment
This project aims to integrate the knowledge system of Traditional Chinese Medicine (TCM) pattern differentiation with TCM knowledge, combining TCM principles with modern Western pharmacology to fundamentally understand the pathogenesis of chemotherapy-induced peripheral neuropathy (CIPN). It employs herbal fumigation and washing therapy for CIPN, offering novel treatment approaches to better guide and assist clinical practice.
Research Methods ：1、A research method combining data collection with clinical application was employed to determine the etiology and pathogenesis of CIPN. The traditional Chinese medicine (TCM) fumigation and washing formula was identified as Modified Huangqi Guizhi Wuwu Decoction: 15 g of Stretching Tendon Grass, 15 g of Chicken Blood Vine, 10 g of Sichuan Aconite, 10 g of Cinnamon Twig, 15 g of Epimedium, 5 g of Safflower, 5 g of Asarum, 15 g of Clematis, Astragalus 15 g, Angelica sinensis 10 g, Paeonia rubra 10 g, and Artemisia argyi 10 g. 2、Subjects were screened according to inclusion and exclusion criteria, and a controlled trial was conducted. Sixty patients were randomly divided into a treatment group and a control group, with 30 patients in each group. Both groups received the following treatment after developing CIPN following administration of oxaliplatin, paclitaxel, and capecitabine: Control Group: Pour 2,000 ml of clean water into the heating pot of the HYZ-IB (2021 model) Traditional Chinese Medicine Steam Therapy Machine, set the preheating temperature to 90°C, and set the steam duration to 30 minutes. Begin steam therapy once the preheating temperature is reached, starting with both upper limbs followed by both lower limbs. Perform once daily; one course of treatment consists of 14 days, and two courses of treatment were administered. Treatment Group: Wrap the Modified Astragalus and Cinnamon Twig Decoction with Five Herbs in gauze, soak it in 2,000 mL of clean water for 10 minutes, and then perform the steam bath using the same method as the control group. 3、 Collect, organize, and analyze the experimental data to draw conclusions.
Emeishan Hospital of Traditional Chinese Medicine is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Inclusion Criteria:
Take Methylcobalamin tablets + herbal steam bath
Drug: Traditional Chinese Medicine Steam Bath
Take methylcobalamin tablets + warm water steam bath
Drug: Traditional Chinese Medicine Steam Bath
Wrap the Modified Astragalus and Cinnamon Twig Decoction with Five Ingredients in gauze, soak it in 2,000 ml of clean water for 10 minutes, then pour it into the heating chamber of the steam therapy machine. Set the preheating temperature to 90°C. set the fumigation time to 30 minutes, and begin fumigation once the preheating temperature is reached. Start with both upper limbs, followed by both lower limbs. Perform once daily; one course of treatment consists of 14 days, and a total of two courses of treatment are recommended.
Patient Experience
Numbness, pain, and abnormal sensations in the hands and feet
Time frame: On days 1, 3, and 5 after fumigation, as well as during the second week and at one month.
CIPN Grading Criteria
On a scale of 0 to 4: Level 0: Asymptomatic; Level 1: Absence of tendon reflexes or numbness (including a prickling sensation), but with no impact on function Level 2: Sensory loss or numbness (including a prickling sensation), affecting function but not daily living activities Level 3: Sensory loss or numbness (including a prickling sensation), affecting daily living activities Level 4: Long-term sensory loss, affecting function
Time frame: On days 1, 3, and 5 after fumigation, as well as during the second week and at one month.
Quality of Life Questionnaire QLQ-C30
(Original Total Score - Number of Questions) / (Number of Questions × 3) × 100，0-19 points: Level 0 (asymptomatic); 20-39 points: Level 1 (mild); 40-69 points: Level 2 (moderate);70-100 points: Levels 3-4 (severe)
Time frame: On days 1, 3, and 5 after fumigation, as well as during the second week and at one month.
Hospital Anxiety and Depression Scale
Add up the scores for the 7 questions：0-7 points Normal range, 8-10 points Mild, 11-14 points Moderate, 15-21 points Severe
Time frame: On days 1, 3, and 5 after fumigation, as well as during the second week and at one month.
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from May 2025 to primary completion in Sep 2026, 15 months.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Emeishan Hospital of Traditional Chinese Medicine