An external-use traditional Chinese medicine composition for treating geriatric debilitation syndrome and application thereof

Abstract

The present application relates to a kind of external use traditional Chinese medicine composition for treating geriatric debilitation syndrome, the traditional Chinese medicine composition is made of the following weight parts of raw medicinal materials: silkworm sand 118-122 parts, Platycladus orientalis 118-122 parts, acanthopanax 88-92 parts, magnetite 88-92 parts, Acorus gramineus 88-92 parts, Radix Curcumae 58-62 parts, wind-preventing plant 28-32 parts, Chuanxiong 28-32 parts, safflower 28-32 parts, eaglewood 28-32 parts, moxa tablet 13-17 parts, cassia 13-17 parts.The present application also provides the application of traditional Chinese medicine composition in preparing geriatric debilitation syndrome medicine.The traditional Chinese medicine pillow of the present application can delay the debilitation state of geriatric debilitation syndrome patient, improve its clinical symptoms by enhancing the sleep quality and cognitive function of geriatric debilitation syndrome patient, improve life quality, and have safety.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a topical traditional Chinese medicine composition for treating senile frailty syndrome and its application. Background Technology Related studies indicate that the prevalence of frailty syndrome in the elderly population in Chinese communities is approximately 10%, and it increases linearly with age. Frailty syndrome is an age-related physiological state that significantly increases the risk of disability in the elderly. While it can affect people of any age, it is more prevalent among the elderly. The main characteristics of frailty include weakened bodily reserves, decreased resistance to external stressors, and dysfunction of the immune and endocrine systems, accompanied by cognitive decline. These changes can adversely affect an individual's overall health. Therefore, frailty syndrome, as a biological syndrome, leads to adverse outcomes due to aging and declining physiological functions, including cognitive impairment, anxiety, falls, insomnia, incontinence, pain, and disability. Furthermore, the elderly often suffer from multiple co-existing conditions, ultimately leading to a low quality of life, chronic illness, and even death. The physical and mental health of the elderly is severely affected by these adverse outcomes, and frailty has attracted increasing attention, becoming a current focus of geriatric medicine research.

[0002] Mild cognitive impairment (MCI) is a pathological condition of cognitive dysfunction, falling between dementia and aging. It cannot yet be definitively diagnosed as dementia. Experts have proposed a definition of "benign amnesia," whose main clinical manifestation is difficulty recalling specific events at particular times, with occasional sudden recall. The concept of "MCI" was first proposed by psychiatrist Petersen, referring to memory impairment and / or mild cognitive decline, while general cognitive and daily living abilities remain. With increasing morbidity, declining nerve cell function, physical disability, and living alone among the elderly, frail elderly individuals are prone to cognitive impairment and mental illnesses. Anxiety and depression are common mental health issues in the elderly. If these conditions occur simultaneously with frailty and cognitive impairment, they can lead to more severe clinical outcomes, such as death. The recognition and treatment rates of cognitive impairment, anxiety, and depression in the later years of life are low, severely impacting the quality of life of the elderly and increasing the economic and socio-psychological burden on families.

[0003] Chinese patent document CN116726112A discloses a traditional Chinese medicine composition for preventing, alleviating, or treating frailty syndrome, comprising: Astragalus membranaceus, Cistanche deserticola, Salvia miltiorrhiza, Euonymus alatus, Polygonatum sibiricum, Hirudo medicinalis, Acorus tatarinowii, Paeonia lactiflora, processed Polygonum multiflorum, processed Glycyrrhiza uralensis, Polygala tenuifolia, Panax ginseng, dextrorotatory borneol, and rice wine. The traditional Chinese medicine composition provided by this invention significantly improves the frailty level, cognitive function, and depressive state in the early stages of frailty in the elderly, and can delay the progression of healthy elderly individuals in the early stages of frailty towards frailty and disability. Given the current lack of clinical treatment methods for frailty syndrome in the elderly, this invention innovatively establishes an effective treatment method for frailty syndrome, which can significantly improve complications such as fatigue and anxiety, enhance the stress response of elderly patients, and has no significant adverse reactions in clinical practice, demonstrating long-term health benefits.

[0004] There are many traditional Chinese medicine compositions for treating geriatric frailty syndrome, but they all have more or less drawbacks, such as difficulty in sourcing raw materials, high prices, and unclear efficacy and poor treatment results. Therefore, there is an urgent need for traditional Chinese medicine compositions that are effective in treating geriatric frailty syndrome, have fewer ingredients, are practical to use, have high compliance, and are safe and effective. Summary of the Invention

[0005] The purpose of this invention is to address the shortcomings of existing technologies by providing a topical traditional Chinese medicine composition for treating senile frailty syndrome and its application.

[0006] In a first aspect, the present invention provides a topical traditional Chinese medicine composition for treating senile frailty syndrome, characterized in that the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 118-122 parts of silkworm excrement, 118-122 parts of cypress seed kernel, 88-92 parts of Acanthopanax senticosus, 88-92 parts of magnetite, 88-92 parts of Acorus tatarinowii, 58-62 parts of turmeric, 28-32 parts of Saposhnikovia divaricata, 28-32 parts of Ligusticum chuanxiong, 28-32 parts of safflower, 28-32 parts of agarwood, 13-17 parts of Artemisia argyi, and 13-17 parts of cinnamon.

[0007] As a preferred example, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 120 parts silkworm excrement, 120 parts cypress seed, 90 parts Acanthopanax senticosus, 90 parts magnetite, 90 parts acorus tatarinowii, 60 parts turmeric, 30 parts saposhnikovia divaricata, 30 parts chuanxiong rhizome, 30 parts safflower, 30 parts agarwood maltose, 15 parts mugwort slices, and 15 parts cinnamon.

[0008] As a preferred example, the external herbal composition is a medicinal pillow.

[0009] Secondly, the present invention provides the application of traditional Chinese medicine compositions in the preparation of drugs for treating senile frailty syndrome.

[0010] As a preferred example, the aforementioned senile frailty syndrome is a syndrome related to kidney qi deficiency and kidney essence deficiency.

[0011] The advantages of this invention are: the herbal pillow can delay the decline in frailty in patients with geriatric frailty syndrome, improve their clinical symptoms and quality of life by enhancing their sleep quality and cognitive function, and is safe. This study highlights the unique role of external herbal treatment in the prevention and treatment of geriatric frailty syndrome, with no obvious toxic side effects, making it easily acceptable to patients and showing good clinical application prospects. It is expected to become a new measure for traditional Chinese medicine intervention in geriatric frailty. Detailed Implementation

[0012] The present invention will be further described below with reference to specific embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. Furthermore, it should be understood that after reading the description of this invention, those skilled in the art can make various alterations or modifications to the invention, and these equivalent forms also fall within the scope defined by the appended claims.

[0013] Example 1: External Traditional Chinese Medicine Composition for Treating Geriatric Frailty Syndrome (I)

[0014] 120 parts silkworm excrement, 120 parts cypress seed kernel, 90 parts Acanthopanax senticosus, 90 parts magnetite, 90 parts calamus, 60 parts turmeric, 30 parts saposhnikovia divaricata, 30 parts chuanxiong rhizome, 30 parts safflower, 30 parts agarwood maltose, 15 parts mugwort slices, and 15 parts cinnamon.

[0015] Example 2: External application of traditional Chinese medicine composition for treating senile frailty syndrome (II)

[0016] 118 parts silkworm excrement, 118 parts cypress seed kernel, 88 parts Acanthopanax senticosus, 92 parts magnetite, 92 parts calamus, 62 parts turmeric, 32 parts saposhnikovia divaricata, 32 parts chuanxiong rhizome, 28 parts safflower, 28 parts agarwood maltose, 13 parts mugwort slices, and 17 parts cinnamon.

[0017] Example 3: External application of traditional Chinese medicine composition for treating senile frailty syndrome (Part 3)

[0018] 118 parts silkworm excrement, 122 parts cypress seed kernel, 88 parts Acanthopanax senticosus, 92 parts magnetite, 88 parts calamus, 62 parts turmeric, 28 parts saposhnikovia divaricata, 32 parts chuanxiong rhizome, 28 parts safflower, 32 parts agarwood maltose, 13 parts mugwort slices, and 17 parts cinnamon.

[0019] Example 4: External Traditional Chinese Medicine Composition for Treating Geriatric Frailty Syndrome (IV)

[0020] 118 parts silkworm excrement, 118 parts cypress seed kernel, 88 parts Acanthopanax senticosus, 88 parts magnetite, 88 parts Acorus tatarinowii, 58 parts turmeric, 28 parts Saposhnikovia divaricata, 28 parts Ligusticum chuanxiong, 28 parts safflower, 28 parts agarwood maltose, 13 parts Artemisia argyi, 13 parts cinnamon.

[0021] Example 5: External Traditional Chinese Medicine Composition for Treating Geriatric Frailty Syndrome (Part 5)

[0022] 122 parts silkworm excrement, 122 parts cypress seed kernel, 92 parts Acanthopanax senticosus, 92 parts magnetite, 92 parts calamus, 62 parts turmeric, 32 parts saposhnikovia root, 32 parts chuanxiong rhizome, 32 parts safflower, 32 parts agarwood maltose, 17 parts mugwort slices, and 17 parts cinnamon.

[0023] Example 6 Clinical Trial

[0024] 1. Clinical Data

[0025] 1.1 Source of cases:

[0026] All cases observed in this study were patients who visited the Geriatrics Department of Shanghai Jing'an District Traditional Chinese Medicine Hospital between January and December 2025. The age was defined as ≥55 years and ≤80 years, and all patients signed informed consent forms.

[0027] 1.2 Diagnostic criteria:

[0028] (1) Western medicine diagnostic criteria for senile frailty syndrome:

[0029] Fried et al. first proposed five clinical features of frailty in 2001, including unexplained weight loss, weakness, muscle weakness, slowed walking speed, and decreased exercise tolerance. These are currently the most widely accepted clinical assessment criteria for frailty, namely the Fried frailty criteria (see Table 1): if three or more of the following are present: unexplained weight loss, slowed movement (slowed walking speed), muscle weakness (decreased grip strength), low physical fitness, and fatigue, a diagnosis of frailty is made; 1-2 are considered pre-frailty; and 0 are considered non-frailty.

[0030] Table 1: Fried's Frailty Assessment Method

[0031]

[0032] (2) Diagnostic criteria for syndromes in Traditional Chinese Medicine:

[0033] Traditional Chinese Medicine (TCM) syndrome differentiation for kidney deficiency: Referencing the related syndromes of kidney qi (deficiency) and kidney essence (qi) deficiency in the "Clinical Terminology of Traditional Chinese Medicine - Syndrome Section" (GB / T 16751.2-1997), and the symptom grading and quantification in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines" (2002 edition), the syndrome is defined as having two primary symptoms of kidney deficiency, or one primary symptom plus two secondary symptoms. Primary symptoms: lower back pain, fatigue, and forgetfulness; Secondary symptoms: insomnia (difficulty falling asleep, vivid dreams and easy awakening, daytime drowsiness), frequent urination at night, and slow movement; Tongue and pulse: pale tongue, white coating, and deep, slow, or weak pulse.

[0034] 1.3 Inclusion criteria:

[0035] ① Age ≥ 55 years old, ≤ 80 years old;

[0036] ②Able to communicate normally and complete the evaluation tests at each stage of this project;

[0037] ③ Meets the diagnostic criteria for frailty syndrome;

[0038] ④ Meets the diagnostic criteria for kidney deficiency syndrome;

[0039] ⑤ Has mild cognitive impairment and / or anxiety, and has not participated in other clinical trials;

[0040] ⑥ Sign an informed consent form to participate in this study.

[0041] 1.4 Exclusion Criteria:

[0042] ①Those under 55 years of age or over 80 years of age;

[0043] ②Those with allergies or who have a history of allergies to aromatic Chinese medicines;

[0044] ③ Patients with critical conditions (such as severe heart failure, severe infection, and tumors);

[0045] ④ Patients with serious primary diseases of the liver, kidneys, hematopoietic system, endocrine system, etc., as well as mental illness and Alzheimer's disease;

[0046] ⑤ Suspected or confirmed history of drug abuse, or other lesions or conditions that, according to the researcher's judgment, reduce the likelihood of enrollment or complicate enrollment, such as frequent changes in work environment, which may lead to loss to follow-up.

[0047] 1.5 Rejection Criteria:

[0048] ① Cases where participants were found to be ineligible for inclusion after enrollment;

[0049] ② Failure to follow medical advice and take medication regularly during the trial;

[0050] ③ The treatment measures used in this trial were not used in accordance with the guidelines after enrollment;

[0051] ④ Cases with no evaluable records.

[0052] The reasons for exclusion should be explained, and their CRF forms should be retained for future reference. No efficacy statistical analysis will be performed on these cases. However, those who have received at least one treatment and have a record can participate in the safety analysis.

[0053] 1.6 Dropout cases:

[0054] ① Definition of shedding

[0055] All participants who completed the informed consent form and passed the screening process to enter the study, regardless of when or why they withdrew, are considered dropouts if they did not complete the observation period specified in the protocol. The reasons for dropouts may include the following:

[0056] ① Poor subject compliance (the prescribed dosage of medication was not achieved, <80% or >120%).

[0057] ❷ Individuals who naturally drop out or are lost to follow-up during observation, including those whose treatment was effective but who could not complete the entire course of treatment, resulting in incomplete clinical data that affected the assessment of efficacy and safety.

[0058] ❸ Cases where serious adverse events or adverse events and complications occur, making it unsuitable to continue the clinical trial and the trial is terminated.

[0059] ❹ If, during the study, a subject develops certain comorbidities, complications, or special physiological changes that may make them unsuitable to continue participating in the study, and the clinical study should be terminated based on the doctor's judgment, then the clinical study for that case will be discontinued.

[0060] 5. If a subject is unwilling to continue the clinical study and requests to withdraw from the clinical study, the subject may withdraw from the clinical study.

[0061] ② Handling of shedding cases:

[0062] After a subject falls out of the study, researchers should maintain contact with the subject as much as possible through methods such as telephone, appointment, home visit, follow-up, and letters, and inquire about the reasons and complete the assessment items that can be completed.

[0063] ③ Conditions for terminating the experiment:

[0064] Trial termination refers to the premature cessation of a clinical trial before its planned completion. The primary purpose of trial termination is to protect the rights of research participants, ensure trial quality, and avoid unnecessary financial losses. This includes:

[0065] ① If a serious safety issue occurs during the experiment, the experiment should be stopped immediately.

[0066] ❷ If the treatment effect is found to be too poor or even ineffective during the trial and has no clinical value, the trial should be terminated to avoid delaying effective treatment for the subjects and to avoid unnecessary economic losses.

[0067] ❸ If a major error is found in the clinical trial protocol during the trial, it is difficult to evaluate the treatment effect; or if a well-designed protocol deviates significantly during implementation, it is difficult to evaluate the treatment effect if it continues.

[0068] ❹ The researcher requests termination (e.g., due to funding or management reasons).

[0069] 5. The administrative department may revoke the experiment, etc.

[0070] 2 Research Methods

[0071] 2.1 Grouping Method

[0072] (1) Sample size calculation:

[0073] This study was divided into groups A and B, using a two-tailed, parallel controlled design. The primary effect indicator was the TCM syndrome score. Based on previous trials, the estimated effective rate was 94.7% in the experimental group and 71.6% in the control group. With α=0.05 and β=0.80, Nt=Nc=38 cases were obtained. Assuming a dropout rate of 20%, Nt=Nc=46 cases, for a total of 92 cases. The expected sample size for each group was 46 cases. The specific formula is as follows:

[0074]

[0075] (2) Randomized grouping:

[0076] The random number table was generated using SPSS 22.0 statistical software. The table was sent to the drug manufacturer, who then numbered the drugs on the packaging. Unrelated personnel sealed each number in an opaque envelope. Patients were randomly assigned to groups A and B in a 1:1 ratio after drawing lots.

[0077] 2.2 Treatment methods

[0078] This study employed a randomized, two-stage crossover controlled clinical trial protocol, randomly assigning participants to group A and group B. The intervention involved two stages of trials to evaluate the patients in multiple dimensions.

[0079] 2.3 Treatment Plan

[0080] Phase 1 Trial: Group A received a herbal pillow combined with routine treatment, while Group B received only routine treatment. The herbal pillow consisted of 120g silkworm excrement, 120g cypress seed, 90g Acanthopanax senticosus, 90g magnetite, 90g Acorus tatarinowii, 60g turmeric, 30g Saposhnikovia divaricata, 30g Ligusticum chuanxiong, 30g safflower, 30g agarwood extract, 15g Artemisia argyi, and 15g cinnamon (manufactured by Shanghai Wanshicheng Pharmaceutical Co., Ltd., commissioned by Shanghai Jing'an District Traditional Chinese Medicine Hospital). Usage: The above 12 herbs were ground into powder using a grinder and then placed into a pre-prepared pillowcase. Patients were instructed to use it every night before sleeping. During sleep or rest, patients should lie on their side or back with their head and neck in contact with the pillow. The herbs, after evaporating, can be absorbed into the body through the nasal mucosa and skin pores to exert their effects. Use for at least 8 hours each night for 3 months. At the same time, patients are instructed to seal the medicated pillow when they have free time to prevent the aroma from evaporating and to place it in a dry place to avoid moisture. Conventional treatment refers to targeted treatment of secondary causes, such as osteoporosis, hypothyroidism, hypertension, anemia, diabetes, and insomnia, before attributing the various manifestations of frailty syndrome to bodily degeneration, in order to delay the existence of frailty in the elderly.

[0081] Phase II trial: After the completion of the first phase (3 months), a 1-month drug washout period was followed by a second assessment of all observation indicators (before intervention). The intervention measures for the two groups were then switched: Group A received only standard treatment, while Group B received a combination of traditional Chinese medicine pillow and standard treatment. Two months later, the subjects underwent the aforementioned assessments.

[0082] 2.4 Evaluation Methods

[0083] This study employed a randomized, two-stage crossover controlled clinical trial protocol, randomly assigning participants to group A and group B. The intervention involved two stages of trials to evaluate the patients in multiple dimensions.

[0084] 2.5 Clinical observation indicators

[0085] (1) General information:

[0086] General record items include: name, gender, age, contact information, diagnosis, medical history, vital signs, and physical examination.

[0087] (2) TCM syndrome scoring and clinical efficacy evaluation:

[0088] This study used the TCM symptom grading and quantification scale in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs" edited by Zheng Xiaoyu in 2002 to score and calculate symptom scores. The TCM syndrome efficacy evaluation criteria are as follows: 0 points for no symptoms or disappearance; 1 point for mild symptoms or occasional symptoms; 2 points for moderate symptoms with varying severity; and 3 points for obvious symptoms.

[0089] Evaluation criteria: Case score = sum of scores for each symptom.

[0090] Clinical cure: The TCM clinical symptoms and signs have disappeared or basically disappeared, and the syndrome score has decreased by ≥90%.

[0091] Significant effect: Clinical symptoms and signs in traditional Chinese medicine showed significant improvement, and the syndrome score decreased by ≥70%.

[0092] Effective: Clinical symptoms and signs in TCM patients improved, and the syndrome score decreased by ≥30%.

[0093] Ineffective: No significant improvement or even worsening of clinical symptoms and signs in Traditional Chinese Medicine, with a decrease in syndrome score of <30%.

[0094] Note: Calculation formula = (Total score before treatment - Total score after treatment) / Total score before treatment × 100%.

[0095] (3) Assessment of the degree of weakness:

[0096] The Tilburg Frailty Scale (TFI) was used. Developed in 2010 by Gobbens' team at the University of Tilburg in the Netherlands, based on an integrated frailty model, this scale is a self-assessment scale for frailty among older adults in the community. It comprises two subscales: one summarizes the potential determinants of frailty, including 10 items (age, gender, education level, income, etc.), which is not scored; the other subscale summarizes the components of frailty, including 15 items across three dimensions: physical frailty, psychological frailty, and social frailty. Physical frailty includes 8 items: physical health, unexplained weight loss, difficulty walking, balance difficulties, hearing problems, vision problems, decreased grip strength, and fatigue; psychological frailty includes 4 items: cognition, depression, anxiety, and coping abilities; and social frailty includes 3 items: living alone, social relationships, and social support. Eleven items on the scale can be answered "yes / no," and the other four can be answered "yes / no / sometimes," but all items are scored using a binary classification method (0 or 1), with a score range of 0-15. The threshold for weakness is 5 points. A score of 5 or above indicates weakness, and the higher the score, the more severe the weakness.

[0097] Record the Tilburg Frailty Scale scores before and after treatment.

[0098] (3) Sleep quality assessment:

[0099] The Pittsburgh Sleep Quality Index (PSQI) was used to comprehensively assess patients' sleep quality before and after treatment. This scale comprehensively and meticulously reflects an individual's sleep quality by evaluating 10 aspects: bedtime, sleep onset time, wake-up time, sleep duration, causes of sleep disturbances, self-reported sleep quality, use of hypnotics, daytime dysfunction, enthusiasm for activities, and bed partner. Lower scores indicate milder symptoms.

[0100] Record the PSQI scores before and after treatment.

[0101] (4) Cognitive function assessment:

[0102] Before and after treatment, the patients' cognitive function was assessed using the Mini Mental Status Examination (MMSE) and the Montreal Cognitive Assessment (MoCA), including aspects such as attention, memory, and language function. The total score ranged from 0 to 30 points, with higher scores indicating better cognitive function.

[0103] (5) Quality of life assessment:

[0104] The Activity of Daily Living (ADL) scale was used to assess the patient's ADL abilities before and after treatment. The total score ranged from 0 to 100, with higher scores indicating greater independence in the patient's ADL activities.

[0105] Record ADL scale scores before and after treatment.

[0106] (6) Safety evaluation indicators and methods:

[0107] Before treatment and at the end of medication, perform routine blood and urine tests and biochemical examinations on the patient. Routine blood tests include WBC, RBC, HGB, and PLT; biochemical tests include ALT, AST, and Cr. If any laboratory values ​​are abnormal and clinically significant, record them on the adverse event form of the case report form, determine their relevance to the medication, and record the follow-up results.

[0108] 2.6 Observation time and follow-up methods:

[0109] The observation period is detailed in 3.2.3. This experiment used telephone follow-up.

[0110] 3. Statistical methods:

[0111] All statistical calculations and processing were performed using SPSS 21.0 for Windows statistical analysis software.

[0112] Descriptive statistical analysis uses frequency tables, percentages, or proportions to describe qualitative indicators; and means, standard deviation, or median, lower quartile (Q1), upper quartile (Q3), minimum, and maximum values ​​to describe quantitative indicators.

[0113] For the comparative analysis of the two groups, qualitative data were analyzed using the chi-square test, Fisher's exact test, and Wilcoxon's rank-sum test. Quantitative data were analyzed using t-tests for data conforming to a normal distribution (with a homogeneity of variance test between groups, using 0.05 as the significance level; if variances were unequal, a Satterthwaite-corrected t-test was used); data not conforming to a normal distribution were analyzed using Wilcoxon's rank-sum test and Wilcoxon's signed-rank test. All hypothesis tests were two-tailed, and the test statistics and corresponding p-values ​​are provided. A p-value ≤ 0.05 was considered statistically significant.

[0114] 4. Research Results:

[0115] (1) Baseline data and comparability analysis of the two groups of patients with frailty syndrome before treatment:

[0116] Statistical analysis of relevant experimental data showed (as shown in Tables 2-4) that there were no differences in baseline data between the two groups of subjects before treatment (P>0.05).

[0117]

[0118] (2) Assessment and analysis of the improvement in frailty level (FP score) before and after treatment in two groups of patients with frailty syndrome:

[0119] Based on the Fried Phenotypic Frailty Scale (FP score) and the Edmonton Frailty Scale (EFS score), statistical analysis of relevant experimental data showed (as shown in Tables 5-6) that, compared with before and after treatment, the combination of traditional Chinese medicine pillow and conventional treatment was more effective in improving the patients' frailty level (P<0.05).

[0120]

[0121] (3) Changes and analysis of total TCM syndrome scores before and after treatment in two groups of patients with frailty syndrome:

[0122] Statistical analysis of relevant experimental data before and after treatment showed (as shown in Tables 7-8) that the combination of Chinese herbal pillow and conventional treatment was more effective in reducing the total TCM syndrome score (P<0.05).

[0123]

[0124] (4) Evaluation and analysis of the improvement in sleep quality, cognitive function and quality of life before and after treatment in the two groups of patients with frailty syndrome:

[0125] Statistical analysis of relevant experimental data before and after treatment showed (as shown in Tables 9-11) that the combination of traditional Chinese medicine pillow and conventional treatment was more effective in improving sleep quality, cognitive function and quality of life in patients with frailty syndrome (P<0.05).

[0126]

[0127]

[0128] (7) Comparison of safety indicators and adverse reactions between the two groups of patients with frailty syndrome before and after treatment:

[0129] Statistical analysis of relevant experimental data (as shown in Tables 12-13) shows that the safety indicators of both groups of subjects were within the normal range before and after treatment, and no adverse symptoms appeared in any group during the treatment period, and no one stopped treatment on their own.

[0130]

[0131] In summary, all the research results confirm that herbal pillows can delay the frailty state of patients with frailty syndrome, improve their clinical symptoms and quality of life by enhancing their sleep quality and cognitive function, and are safe. This study highlights the unique role of external herbal treatment in the prevention and treatment of frailty syndrome, with no obvious toxic side effects, making it easily accepted by patients and showing good clinical application prospects. It is expected to become a new measure for traditional Chinese medicine intervention in frailty in the elderly.

Claims

1. A topical traditional Chinese medicine composition for treating senile frailty syndrome, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 118-122 parts silkworm excrement, 118-122 parts cypress seed, 88-92 parts Acanthopanax senticosus, 88-92 parts magnetite, 88-92 parts acorus tatarinowii, 58-62 parts turmeric, 28-32 parts saposhnikovia divaricata, 28-32 parts chuanxiong rhizome, 28-32 parts safflower, 28-32 parts agarwood, 13-17 parts mugwort, and 13-17 parts cinnamon.

2. The topical traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 120 parts silkworm excrement, 120 parts cypress seed, 90 parts Acanthopanax senticosus, 90 parts magnetite, 90 parts acorus tatarinowii, 60 parts turmeric, 30 parts saposhnikovia divaricata, 30 parts chuanxiong rhizome, 30 parts safflower, 30 parts agarwood maltose, 15 parts mugwort slices, and 15 parts cinnamon.

3. The external application traditional Chinese medicine composition according to claim 1 or 2, characterized in that, The aforementioned external application Chinese herbal medicine composition is a medicinal pillow.

4. The use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of a drug for treating senile frailty syndrome.

5. The application according to claim 4, characterized in that, The aforementioned senile frailty syndrome is a syndrome related to kidney qi deficiency and kidney essence deficiency.

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