Traditional Chinese medicine incense composition for treating insomnia disorder of children and application of traditional Chinese medicine incense composition

Abstract

The invention discloses a traditional Chinese medicine incense composition for treating insomnia disorder of children, which is prepared by adding pharmaceutically acceptable auxiliary materials or a pharmaceutically acceptable matrix into the following raw material medicines in parts by weight: 10-30 parts of agilawood, 5-15 parts of frankincense, 15-45 parts of rhizoma nardostachyos, 15-45 parts of albizia flower, 15-45 parts of lavender, 5-15 parts of jasmine flower and 2.5-7.5 parts of radix angelicae. And an auxiliary material: 13.5-40.5 parts of elm bark powder. Through clinical research and test application, the incense traditional Chinese medicine composition disclosed by the invention can effectively improve the clinical symptoms such as difficulty in falling asleep, dreaminess and easy waking, low emotion, impatience and irritability, hypochondriac pain, abdominal distension and belching, diet and defecation of child patients, improves the life quality of the child patients, has no toxic or side effects and good safety, and can be used for treating insomnia disorder of children.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine incense composition for treating children's insomnia and an application thereof. Background Art

[0002] Insomnia is also known as sleep deprivation in traditional Chinese medicine. Mild cases have difficulty falling asleep or wake up easily after falling asleep and cannot fall asleep again after waking up. Severe cases cannot fall asleep all night. According to global statistics, the incidence of insomnia is 9%-15%, which is a high incidence and has great harm. At present, Western medicine treats insomnia with benzodiazepines, non-benzodiazepines, The main drugs are melatonin receptor agonists, orexin receptor antagonists or antihistamines, but there are currently no drugs approved for the treatment of insomnia in children and adolescents at home and abroad.

[0003] The applicant previously achieved excellent results with the traditional Chinese medicine Qianyang Anshen formula for treating insomnia in children caused by excessive heart and liver fire. Previous epidemiological surveys have found that insomnia caused by liver-stomach disharmony and restlessness is also a common clinical syndrome. Aromatherapy is a painless external treatment method that absorbs medicinal properties through the skin, pores, and five orifices. It is safe, economical, simple, and easy to use. It not only provides psychological comfort to children but also treats their condition. It is suitable for the physiological and pathological characteristics of adolescents and is therefore more acceptable.

[0004] Jiang Yonghong, referring to classic incense such as Anhunxiang and Ersu Jiuju in Chen Yunjun's "Yanju Xiangyu," combined with the TCM pathogenesis of liver-stomach disharmony and restlessness, formulated the present Chinese medicine incense composition (hereinafter also referred to as Yuexi Chenhuanxiang). "Yuexi Chenhuanxiang" is made with agarwood, spikenard, jasmine, angelica, frankincense, julibrissin, and lavender. It has the effects of soothing the liver and stomach, calming the mind and relieving depression, helping children relax, relieve stress, and fall asleep peacefully. The clinical application effect is significant. Therefore, we further designed a relevant clinical trial to evaluate the efficacy of Yuexi Chenhuanxiang in treating insomnia in children. Summary of the Invention

[0005] In view of the lack of traditional Chinese medicine in treating insomnia disorders in children and the above-mentioned deficiencies in the existing technology, according to the embodiments of the present invention, it is hoped to provide a traditional Chinese medicine incense composition for treating insomnia disorders in children, so as to provide an effective treatment for insomnia disorders in children, effectively improve the clinical symptoms of children with insomnia disorders, and improve the quality of life.

[0006] According to the embodiments, the present invention provides a traditional Chinese medicine incense composition for treating insomnia in children, which is prepared by adding the following raw materials in parts by weight and pharmaceutically acceptable excipients or pharmaceutically acceptable matrices: 10-30 parts of agarwood, 5-15 parts of frankincense, 15-45 parts of spikenard, 15-45 parts of julibrissin flowers, 15-45 parts of lavender, 5-15 parts of jasmine, 2.5-7.5 parts of angelica dahurica, and excipient: 13.5-40.5 parts of elm bark powder.

[0007] According to the embodiment, in the aforementioned traditional Chinese medicine incense composition for treating insomnia in children of the present invention, the weight proportions of the raw materials are preferably: 20 parts of agarwood, 10 parts of frankincense, 30 parts of spikenard, 30 parts of julibrissin, 30 parts of lavender, 10 parts of jasmine, and 5 parts of angelica dahurica, and the weight proportions of the auxiliary materials are preferably: 27 parts of elm bark powder.

[0008] The preparation method of the traditional Chinese medicine incense composition is as follows: raw materials are powdered and sieved, mixed in a ratio of 2:1:3:3:3:1:0.5, 20% of the total amount of the traditional Chinese medicine powder is used as a binder, namely elm bark powder, and an appropriate amount of water is added and stirred evenly to form an incense paste. An incense stick with a diameter of 2 mm and a length of 21 cm is formed using an incense squeezer, and then heated with a hair dryer at 55 degrees for 2-3 minutes until half dry, and then placed in a cool place to dry for 3 days until completely dry.

[0009] Clinical research and application have shown that the incense fumigation Chinese medicine composition of the present invention can effectively improve clinical symptoms such as difficulty falling asleep, frequent dreams and easy awakening, depression, irritability, flank pain, abdominal distension and belching, diet, and bowel movements in children, thereby improving the quality of life of the children. It has no toxic side effects and is safe, and can be used to treat insomnia disorders in children.

[0010] The pharmacological effects of the Chinese medicinal incense composition of the present invention are as follows: targeting the pathological characteristics of liver-stomach disharmony and restlessness in children with insomnia disorder, the composition uses liver-stomach disharmony, spleen-invigorating and stomach-harmonic products to relieve depression, soothe the liver, invigorate the spleen and regulate qi, harmonize the stomach and tranquilize the mind, so as to treat insomnia disorder caused by liver-stomach disharmony and restlessness, and generally aims to soothe the liver and stomach, and calm the mind and tranquilize the mind.

[0011] The Chinese herbal incense composition of the present invention has the effects of calming the liver and stomach, soothing the mind, and treating insomnia in children. It can effectively improve symptoms such as difficulty falling asleep, frequent dreams and frequent awakenings, depression, irritability, flank pain, abdominal distension and belching, and problems with diet and bowel movements. Furthermore, the Chinese herbal incense composition of the present invention is made from pure Chinese herbs and is applied externally as an aromatherapy treatment. It has no toxic side effects and is easily accepted by children and their families. DETAILED DESCRIPTION

[0012] The present invention will be further described below in conjunction with specific examples. These examples should be understood to be merely illustrative of the present invention and not intended to limit the scope of protection of the present invention. After reading the contents described herein, those skilled in the art may make various changes or modifications to the present invention, and these equivalent variations and modifications also fall within the scope defined by the claims of the present invention.

[0013] In the following examples of the present invention, experimental methods not specifically indicated are all commonly used experimental methods in the art.

[0014] In the following examples of the present invention, all reagents not specifically indicated are commercially available.

[0015] Example 1

[0016] Weigh 20g of agarwood, 10g of frankincense, 30g of spikenard, 30g of julibrissin, 30g of lavender, 10g of jasmine, 5g of angelica dahurica, and auxiliary material: 27g of elm bark powder.

[0017] Powder and sieve the raw materials, then mix them in a ratio of 2:1:3:3:3:1:0.5. Use elm bark powder, which accounts for 20% of the total Chinese medicinal powder, as a binder. Add an appropriate amount of water and mix thoroughly to create an incense paste. Use an incense squeezer to form incense sticks with a diameter of 2mm and a length of 21cm. Heat the sticks with a hair dryer at 55°C for 2-3 minutes until they are partially dry. Then, place them in a cool, dry place for 3 days until they are completely dry.

[0018] Example 2

[0019] Weigh 20g of agarwood, 10g of frankincense, 30g of spikenard, 30g of julibrissin, 30g of lavender, 10g of jasmine, 5g of angelica dahurica, and auxiliary material: 40.5g of elm bark powder.

[0020] Powder and sieve the raw materials, then mix them in a ratio of 2:1:3:3:3:1:0.5. Use elm bark powder, which accounts for 30% of the total Chinese medicinal powder, as a binder. Add an appropriate amount of water and mix thoroughly to create an incense paste. Use an incense squeezer to form incense sticks with a diameter of 2mm and a length of 21cm. Heat the sticks with a hair dryer at 55°C for 2-3 minutes until they are partially dry. Then, place them in a cool, dry place for 3 days until they are completely dry.

[0021] Example 3

[0022] Weigh 20g of agarwood, 10g of frankincense, 30g of spikenard, 30g of julibrissin, 30g of lavender, 10g of jasmine, 5g of angelica dahurica, and auxiliary material: 13.5g of elm bark powder.

[0023] Powder and sieve the raw materials, then mix them in a ratio of 2:1:3:3:3:1:0.5. Use elm bark powder, which accounts for 10% of the total Chinese medicinal powder, as a binder. Add an appropriate amount of water and stir evenly to make an incense paste. Use an incense squeezer to form incense sticks with a diameter of 2mm and a length of 21cm. Heat the sticks with a hair dryer at 55 degrees for 2-3 minutes until they are partially dry. Place in a cool, dry place for 3 days until they are completely dry.

[0024] Experimental Example - Clinical Observation on the Treatment of Insomnia in Children with the Traditional Chinese Medicine Incense Composition of the Present Invention (Yuexi Chenhuanxiang)

[0025] 1. Case selection

[0026] Sixty children with insomnia who met the inclusion criteria and visited the outpatient clinic between May and December 2024 were recruited and randomly divided into a treatment group (30 cases) and a control group (30 cases) for clinical observation.

[0027] (1) Western medicine diagnostic standards

[0028] Refer to the diagnostic criteria for insomnia in the Chinese Classification and Diagnostic Criteria for Mental Disorders (CCMD-3):

[0029] 1) Insomnia is almost the only symptom, including difficulty falling asleep, shallow sleep, frequent dreams, early awakening, difficulty falling asleep again after waking up, discomfort after waking up, fatigue, and daytime sleepiness.

[0030] 2) Having a dominant concept of insomnia and being extremely concerned about insomnia.

[0031] 3) Occurs at least 3 times a week for at least 1 month.

[0032] (2) Traditional Chinese Medicine diagnostic criteria

[0033] Refer to the diagnostic criteria for insomnia in the Traditional Chinese Medicine Industry Standards of the People's Republic of China, "Standards for Diagnosis and Efficacy of Diseases and Syndromes in Traditional Chinese Medicine (XI)":

[0034] 1) Mild cases may cause difficulty falling asleep or waking up easily, and then not being able to fall asleep again after waking up; severe cases may cause difficulty sleeping all night;

[0035] 2) Often accompanied by headache, drowsiness, palpitations, forgetfulness, and frequent dreams;

[0036] 3) No abnormalities were found in the examination of various systems and laboratories.

[0037] TCM Syndrome Diagnosis: Refer to the State Administration of Technical Supervision's "TCM Clinical Diagnosis and Treatment Terminology - Syndrome Section" and the key points for distinguishing "Insomnia - Liver-Stomach Disharmony and Restlessness" in "Practical TCM Pediatrics," edited by Zhang Qiwen and Zhu Jinshan. Liver-Stomach Disharmony and Restlessness: Mild cases can cause difficulty falling asleep or frequent awakenings during sleep, while severe cases can lead to sleeplessness all night long. Symptoms may include headaches and dizziness, flank pain, abdominal distension and belching, depression or irritability, poor appetite, constipation or sticky stools, a red tongue with a thin yellow or white coating, and a wiry, slow pulse.

[0038] (3) Inclusion criteria

[0039] 1) Meet the Western medical diagnostic criteria for insomnia; 2) Age 12-18 years old, regardless of gender; 3) Meet the Traditional Chinese Medicine (TCM) criteria for insomnia (liver-stomach disharmony and restlessness); 4) Have a mild to moderate insomnia condition, as assessed using the ISI scale; 5) Sign the informed consent form.

[0040] (4) Exclusion criteria

[0041] 1) Exclude patients with insomnia caused by physical discomfort, such as cough, asthma, pain, itching, etc.; 2) Exclude patients with asthma and allergic rhinitis; 3) Exclude patients with secondary insomnia caused by severe mental illness; 4) Exclude patients with severe primary diseases such as respiratory, circulatory, and digestive system diseases; 5) Patients participating in clinical trials of other drugs; 6) Patients who are likely to be lost to follow-up according to the doctor's judgment.

[0042] (5) Rejection, shedding and termination test criteria:

[0043] 1) Cases that were mistakenly included because they did not meet the inclusion criteria; 2) Children with poor compliance who were unable to undergo aromatherapy treatment according to the prescribed requirements; 3) Patients with allergic reactions, serious adverse reactions, complications, or who the researcher determined should stop the trial.

[0044] 2. Test methods

[0045] 2.1. SPSS 26.0 statistical software was used to set a random number seed according to the number of cases, generate random numbers, and divide the patients into Group A (control group) and Group B (treatment group). Each group had 30 cases, for a total of 60 children. Comfort incense was used in Group A, and Yuexi Chenhuan incense was used in Group B.

[0046] 2.2. Drug preparation:

[0047] (1) How to make Yue Xi Agarwood Incense

[0048] Ingredients: Agarwood, frankincense, spikenard, julibrissin, lavender, jasmine, and angelica purchased from Yuanji Traditional Chinese Medicine Pharmacy. Excipient: elm bark powder.

[0049] Preparation steps: Powder and sieve the raw materials, then mix them in a ratio of 2:1:3:3:3:1:0.5. Use elm bark powder, which accounts for 20% of the total Chinese herbal powder, as a binder. Add an appropriate amount of water and stir evenly to form an incense paste. Use an incense squeezer to form incense sticks with a diameter of 2mm and a length of 21cm. Heat the mixture with a hair dryer at 55°C for 2-3 minutes until partially dry. Place in a cool, dry place for 3 days until completely dry.

[0050] (2) Placebo incense production method

[0051] Ingredients: Agarwood fragments (from which the agarwood oil has been extracted)

[0052] Excipients: elm bark powder

[0053] Production process: crush the extracted agarwood essential oil slices into powder, sieve them and mix them with elm bark powder in a ratio of 1:4, mix them with water, use an incense squeezer to squeeze out incense sticks with a diameter of 2mm and a length of 21cm, then use a 55-degree hair dryer to blow with hot air for 2-3 minutes until half dry, then dry them in a cool place for 3 days until they are completely dry, and you can make comfort incense.

[0054] (3) Safety testing:

[0055] Yuexi Chenhuan Incense is manufactured by the incense factory of Guangdong Qinan Technology Co., Ltd. After production, it is sent to Yongchun Fengye Agricultural Technology Co., Ltd. (Yongchun Product Quality Inspection Institute) for safety testing. China has recognized the international mutual recognition of testing and testing CNAS L10343 certification. The inspection is based on GB 26386-2011 "General Technical Requirements for Safety of Incense Products". The test items include combustion safety performance, post-combustion [formaldehyde (HCHO), benzene (C6H6), toluene (C8H 10 ), total volatile organic compound (TVOC) concentration], and release concentrations of migratable elements [lead (Pb), cadmium (Cd), mercury (Hg), chromium (Cr), and arsenic (As)], all met the test standards in the test results.

[0056] Control group: Placement incense was lit one hour before bedtime in a slightly ventilated area to facilitate the diffusion of the fragrance while avoiding direct heat from the heater, which could affect the diffusion time and speed. Incense was used once per night for 28 consecutive days.

[0057] Treatment Group: Treatment incense was lit one hour before bedtime in a slightly ventilated area to facilitate the diffusion of the fragrance, while avoiding direct heat exposure, which could affect the diffusion time and speed. Frequency of use: One stick per night for 28 consecutive days.

[0058] 3. Observation indicators

[0059] (1) Insomnia Severity Index (ISI): The scale contains seven questions, including the difficulty the child has falling asleep, the difficulty staying asleep, early awakening, whether others notice their sleep problems, and the degree of their own concerns about insomnia. Each question is scored from 0 to 4 points, and the total score range is 0 to 28 points. The severity of insomnia is determined based on the score results. The score can be divided into 0-7 points for insomnia without clinical significance, 8-14 points for subclinical insomnia (mild insomnia), 15-21 points for clinical insomnia (moderate insomnia), and 22-28 points for clinical insomnia (severe insomnia).

[0060] (2) Traditional Chinese Medicine Syndrome Rating Scale

[0061]

[0062]

[0063] (3) Sleep data: On the first night of enrollment, the child lights the test incense, wears the sleep bracelet to sleep, and fills in the sleep diary the next morning. The child's parents can fill in the sleep diary on their behalf, or the child can fill in the sleep diary by themselves. Contact the child's parents on WeChat and ask them to take a photo of the data and the completed line of the sleep diary and upload it the next day after enrollment to ensure that it is filled out correctly. Review the sleep diary every two weeks to ensure that the experiment is on schedule. Wear the sleep bracelet before going to bed at night and take it off after waking up in the morning. Wear it for 4 weeks. Total time in bed (TIB), wake time after falling asleep (WASO), total sleep time (TST), and sleep onset latency (SOL). TST = TIB-SOL-WASO, calculate sleep efficiency (SE).

[0064] SE calculation formula: SE = (TST / TIB) × 100%

[0065] (4) Safety evaluation: nasal congestion, runny nose, dyspnea, nausea and vomiting; liver and kidney function, electrocardiogram.

[0066] 4. Efficacy evaluation criteria

[0067] Disease efficacy: Insomnia Severity Index (ISI) score reduction rate

[0068] (Refer to the "Insomnia Diagnosis and Treatment Plan" of the Medical Administration Department of the State Administration of Traditional Chinese Medicine

[0069] 1. Clinical recovery: refers to a reduction rate of ≥75% on the Insomnia Severity Index Scale, with symptoms completely or essentially disappearing;

[0070] 2. Significantly effective: 50% or less of symptoms have basically disappeared, and the Insomnia Severity Index score reduction rate is less than 75%;

[0071] 3. Effective: 25% or less of symptoms have improved or partially improved, and the Insomnia Severity Index score reduction rate is less than 50%;

[0072] 4. Ineffective: Insomnia Severity Index score reduction rate <25%.

[0073] Efficacy of TCM syndromes: evaluated with reference to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines" issued by the State Food and Drug Administration.

[0074] Clinical recovery: The cumulative syndrome score decreases by ≥95%, and all TCM symptoms and signs disappear;

[0075] Significantly effective: The cumulative syndrome score decreased by ≥70% to 94%, and the TCM symptoms basically disappeared;

[0076] Effective: The cumulative syndrome score decreased by ≥30% to 70%, and the TCM symptoms improved or partially improved;

[0077] Ineffective: The cumulative symptom score decreased by less than 30%.

[0078] Calculation method of efficacy index (n): [(pre-treatment score)-(post-treatment score) / pre-treatment score] x 100%

[0079] 5. Statistical methods

[0080] SPSS 25.0 software was used for statistical analysis, and the measurement data were expressed as mean ± standard deviation. Statistical description was performed. Intergroup differences were compared using the independent sample t-test for data that met normal distribution. Repeated measures analysis of variance and simple effects analysis were used to compare intergroup and intragroup differences at different time points. For data that did not meet normal distribution, the median (25th percentile, 75th percentile) [P50 (P25, P75)] was used for statistical description. Intergroup comparisons were performed using the Mann-Whitney U rank-sum test. For single-item ordinal data, intergroup comparisons were performed using the Mann-Whitney U rank-sum test, and intragroup comparisons were performed using the Wilcoxon test. P < 0.05 was considered statistically significant.

[0081] 6. Experimental Results

[0082] 1) General Information

[0083] There was no statistically significant difference in the baseline data of the two groups of children in terms of gender, age, and disease severity (P>0.05), ensuring the comparability of the two groups.

[0084] 2) Comparison of the efficacy between the two groups is shown in Table 1. The effective rate of the control group was 60%, and that of the treatment group was 93.3%. The treatment group was superior to the control group (P<0.001).

[0085] 3) Comparison of TCM syndrome efficacy between the two groups of children is shown in Table 2. The effective rate was 50% in the control group and 83.3% in the treatment group. The treatment group was superior to the control group (P<0.001).

[0086] 4) The sleep onset latency (SOL) of the two groups of children is compared in Table 3. The SOL of both groups improved compared with before, and the SOL of the treatment group was better than that of the control group (P<0.05).

[0087] 5) The comparison of wakefulness time after falling asleep (WASO) between the two groups is shown in Table 4. No improvement was observed in the control group after treatment, while WASO was shortened in the treatment group, which was significantly better than that in the control group (P<0.05).

[0088] 6) The comparison of sleep efficiency between the two groups is shown in Table 5. The SE of both groups was improved compared with the previous period, and the SE of the treatment group was better than that of the control group (P<0.001).

[0089] 7) Comparison of TCM syndrome scores between the two groups is shown in Table 6. After 4 weeks of treatment, intergroup comparisons showed that all scores in the treatment group were significantly better than those in the control group (all P < 0.05). Intragroup comparisons showed that all scores in the treatment group were significantly better after treatment than before treatment (all P < 0.05); the difficulty falling asleep score in the control group was significantly better after treatment than before treatment (P < 0.05). No significant improvement was observed in the other scores (all P > 0.05).

[0090] During this clinical study, neither group of children experienced adverse reactions such as nasal congestion, runny nose, difficulty breathing, nausea and vomiting, dizziness, headache, chest tightness, or liver and kidney function damage.

[0091] Table 1. Comparison of disease efficacy between the two groups of children [n (%)]

[0092]

[0093] Table 2. Comparison of TCM efficacy between the two groups of children [n (%)]

[0094]

[0095] Table 3. Comparison of SOL between the two groups of children (P25, P50, P75)

[0096]

[0097] Table 4. Comparison of WASO between the two groups (P25, P50, P75)

[0098]

[0099] Table 5. Comparison of SE between the two groups of children before and after treatment (x±S)

[0100]

[0101] Table 6. Comparison of TCM syndrome scales between the two groups of children (P25, P50, P75)

[0102]

[0103]

[0104] In summary, the traditional Chinese medicine incense composition of the present invention can effectively shorten the sleep onset latency, reduce wake time, improve sleep efficiency, and alleviate the severity of insomnia in adolescents with insomnia. Yuexi Chenhuan Incense can effectively improve emotional problems and gastrointestinal symptoms in adolescents with insomnia. It has significant clinical efficacy in treating adolescent insomnia with no toxic side effects and is worthy of clinical promotion and application.

Claims

1. A Chinese medicinal incense composition for treating insomnia in children, characterized in that The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 10-30 parts of agarwood, 5-15 parts of frankincense, 15-45 parts of spikenard, 15-45 parts of julibrissin, 15-45 parts of lavender, 5-15 parts of jasmine, and 2.5-7.5 parts of angelica dahurica.

2. The Chinese medicinal incense composition for treating insomnia in children according to claim 1, wherein The auxiliary material or matrix is ​​elm bark powder, and the weight portion of the elm bark powder is 13.5-40.5 parts by weight.

3. The Chinese medicinal incense composition for treating insomnia in children according to claim 1, wherein The weight proportions of the raw materials are: 20g agarwood, 10g frankincense, 30g spikenard, 30g julibrissin, 30g lavender, 10g jasmine, and 5g angelica.

4. The Chinese medicinal incense composition for treating insomnia in children according to claim 3, wherein The auxiliary material or matrix is ​​elm bark powder, and the weight portion of the elm bark powder is 27 parts by weight.

5. Use of the traditional Chinese medicine composition according to any one of claims 1 to 4 in the preparation of an external-use medicament for treating insomnia disorders in children.

6. The use according to claim 5, characterized in that: The external medicine is incense.

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