An Early Phase 1 interventional study of Twelve-Ingredient Prepared Sichuan Aconite Hand and Foot Bath and Standard Basic Nursing Interventions in Palmar and Plantar Erythema, Numbness of the Four Limbs and Pain in the Distal Extremities, sponsored by Emeishan Hospital of Traditional Chinese Medicine. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Emeishan Hospital of Traditional Chinese Medicine · Early Phase 1, Interventional, and Treatment
This study is a prospective, single-center, randomized, parallel-group, open-label clinical trial titled "Intervention with the 'Xu Xue Tong Luo Traditional Chinese Medicine Compound for Capecitabine-Related Hand-Foot Syndrome." The research hypothesis is that adding this traditional Chinese medicine hand and foot bath to standard baseline care will result in a significantly higher efficacy rate-defined as a ≥1-grade reduction in Hand-Foot Syndrome (HFS) severity after 3 weeks-compared to baseline care alone.The study plans to enroll 110 patients with capecitabine-related Grade 1-2 HFS (with some eligible Grade 3 patients), who will be randomized in a 1:1 ratio to the control group and the intervention group. The control group will receive standard baseline care; the intervention group will receive standard baseline care supplemented with a fixed 12-ingredient traditional Chinese medicine hand-and-foot bath, in which processed Aconite is pre-decocted to reduce toxicity. Patients will soak their hands and feet in the decoction at 38-41°C at least 4 times per week for 3 consecutive weeks.Primary endpoint: The proportion of patients with a ≥1-grade reduction in HFS score from baseline after 3 weeks of intervention.
This study is a prospective, single-center, randomized, parallel-group, open-label clinical trial titled "Intervention with the Xu Xue Tong Luo Traditional Chinese Medicine Compound for Capecitabine-Related Hand-Foot Syndrome." The study plans to enroll 110 patients with Grade 1-2 (and some Grade 3 cases without acute inflammation) capecitabine-related hand-foot syndrome, who will be randomized in a 1:1 ratio to two groups. The control group will receive standard baseline care; the intervention group will additionally receive a fixed 12-ingredient Chinese herbal hand and foot bath, containing processed Aconite, Cinnamomum twig, Asarum, Astragalus, Angelica sinensis, and others. Processed Aconite will be decocted for 30-60 minutes to reduce toxicity. The herbal solution will be maintained at 38-41°C, and patients will soak for 15-20 minutes at least 4 times per week for 3 consecutive weeks. The primary endpoint was the proportion of patients with a ≥1-grade reduction in HFS score after 3 weeks compared to baseline; secondary endpoints included pain NRS, capecitabine dose maintenance rate, EORTC QLQ-C30 quality of life, and time to first improvement. Safety monitoring focused on local skin reactions and aconitine-related symptoms such as numbness of the mouth and tongue, palpitations, and arrhythmias, with follow-up electrocardiograms and liver and kidney function tests. The study employed centralized randomization, concealed allocation, single-blind outcome assessment, and independent statistical analysis, adhering to guidelines such as CONSORT and TIDieR. It is expected to validate the efficacy and safety of the treatment and establish a standardized operating procedure (SOP) for traditional Chinese medicine hand and foot baths.
47 studies on the registry are indexed under Hand-Foot Syndrome; 10 are open to participants now.
This study's planned enrollment of 7 is below the median of 58 across 38 interventional studies indexed under Hand-Foot Syndrome.
Browse Hand-Foot Syndrome studies →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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Exclusion Criteria:
Standard Basic Care + Hand and Foot Bath with Twelve-Ingredient Processed Sichuan Aconite 1 Fixed Formula (Uniformly and Independently Packaged by the Hospital's Traditional Chinese Medicine Pharmacy) Shenjincao 15 g, Jixueteng 15 g, Processed Sichuan Aconite 10 g, Guizhi 15 g, Yinyanghuo 15 g, Honghua 15 g, Xixin 5 g, Weilingxian 15 g, Huangqi 30 g, Angelica sinensis 15 g, Paeonia rubra 15 g, Artemisia argyi 15 g; The outer packaging must clearly state "For external use only; do not take orally," and separately indicate the requirement to decoct processed Aconite root first. 7.2.2 Standardized Decoction Procedure 1.1. Soak all herbal ingredients in clean water for 30 minutes; 2.2. Add water to the processed Aconite (Zhi Chuan Wu) separately and decoct for 30-60 minutes to reduce toxicity; then add all remaining herbal ingredients. This decoction protocol complies with the Pharmacopoeia and the unified toxicity-reduction standards for external preparations containing Aconite \[9\]; 3.
Drug: Twelve-Ingredient Prepared Sichuan Aconite Hand and Foot Bath
1.1. Basic Care: Gently wash hands and feet daily with warm water, and apply a generous amount of non-irritating medical-grade moisturizer to both hands and feet; 2.2. Daily Protection Education: Strictly avoid washing with hot water, contact with high-temperature objects, prolonged friction, pressure, and exposure to direct sunlight. The standard Western medical care protocol is uniformly recommended by current domestic and international guidelines \[3\]; 3.3. Symptomatic Treatment: For patients with significant pain, use only conventional Western medical symptomatic pain relief; the use of any herbal baths or topical herbal preparations is strictly prohibited throughout the entire treatment period; 4. Intervention Period: Provide continuous, standardized care for 3 weeks, with weekly outpatient follow-up evaluations.
Other: Standard Basic Nursing Interventions
Prepare a traditional Chinese medicine decoction, maintain the temperature of the decoction between 38 and 41°C, completely submerge both hands and feet in the decoction for 15 to 20 minutes, soak at least 4 times a week, and continue the treatment for 3 consecutive weeks.
1\. Basic Care: Gently wash hands and feet daily with warm water, and apply a generous amount of non-irritating medical-grade moisturizer to both hands and feet; 2. Education on Daily Protection: Strictly avoid washing with hot water, contact with high-temperature objects, prolonged friction, pressure, and excessive sun exposure. This is the standard Western medical care protocol uniformly recommended by current domestic and international guidelines \[3\]; 33. Symptomatic Management: For patients with significant pain, use only conventional Western medical symptomatic pain relief; the use of any herbal foot baths or topical herbal preparations is strictly prohibited throughout the entire treatment period; 4. Intervention Period: Provide continuous, standardized care for 3 weeks, with weekly outpatient follow-up evaluations.
Hand-Foot Syndrome Grading
Grade 1: Numbness, paresthesia, or tingling in the hands and feet. Grade 2: Discomfort in holding objects or walking; painless swelling or erythema. Grade 3: Painful erythema, edema of the palms and soles, periungual erythema, and swelling. Grade 4: Desquamation, ulceration, blistering, and severe pain.
Time frame: on the day of enrollment, at week 1, at week 3, and on day 7 after completion of the intervention
numeric rating scale (NRS) score
The NRS (Numeric Rating Scale) is a simple tool used to assess pain intensity, usually scored from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain.
Time frame: on the day of enrollment, at week 1, at week 3, and on day 7 after completion of the intervention
capecitabine dose maintenance rate
capecitabine dose maintenance rate during the 3-week observation period
Time frame: on the day of enrollment, at week 1, at week 3, and on day 7 after completion of the intervention
Quality of life score (EORTC QLQ-C30)
Time frame: on the day of enrollment, at week 1, at week 3, and on day 7 after completion of the intervention
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Oct 2026, 0 months later.
How these figures are worked out, and which studies are left out of them.
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 not yet recruiting, 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