A traditional chinese medicine composition for treating anxiety

Abstract

The application provides a traditional Chinese medicine composition for treating anxiety, which is made of Yujin, Zhizi, Lianzi, Qingluoshi, Jineijin and Suanzhiren. Clinical research shows that the anti-anxiety effective rate of the traditional Chinese medicine composition of the application in the second week is 64%, which is significantly better than that of traditional western medicine paroxetine hydrochloride; at the end of the test, the total effective rate of the traditional Chinese medicine composition of the application reaches 75.2%, which is significantly improved compared with the anti-anxiety western medicine paroxetine hydrochloride; and no side effect is found in taking the traditional Chinese medicine composition of the application.

Description

Technical Field

[0001] This application relates to a traditional Chinese medicine composition for treating anxiety disorder, belonging to the field of traditional Chinese medicine technology. Background Technology

[0002] Anxiety disorder is a mental disorder characterized by anxiety syndrome. It manifests as both psychological and physical symptoms. Psychological symptoms refer to an inner experience of worry, fear, and anxiety, accompanied by tension and restlessness. Physical symptoms are symptoms of autonomic nervous system hyperactivity accompanying the psychological symptoms, such as palpitations, chest tightness, shortness of breath, dry mouth, sweating, muscle tension tremor, tremors, facial flushing or pallor, etc. The lifetime prevalence of anxiety disorders is 13.6%–28.8%, and the annual prevalence is 5.6%–19.3%, with a high comorbidity rate. 43.5% of patients with anxiety disorder also experience depressive episodes, severely impacting their quality of life.

[0003] Modern medicine categorizes anxiety disorders into many treatment models and methods, but most can be classified into two main categories: biological therapy and psychosocial therapy. Biological therapy includes medication, electroconvulsive therapy, and phototherapy; psychosocial therapy includes supportive psychotherapy, psychodynamic therapy, interpersonal therapy, cognitive behavioral therapy, marital and family therapy, and art therapy. Anti-anxiety medication is currently the main clinical treatment for anxiety disorders. SSRIs (antidepressants based on SSRIs) and benzodiazepines are currently first-line treatments. However, they often cause excessive sedation, gastrointestinal reactions, and cardiovascular reactions. SSRIs typically take 2-3 weeks to take effect and require long-term use to maintain efficacy. Benzodiazepines, while having a faster onset of action, have difficulty maintaining their effect and require prolonged use to maintain their anti-anxiety effect. However, long-term use can easily lead to addiction or drug tolerance, often resulting in long-term use and addiction. They can also cause excessive sedation, leading to dizziness, lightheadedness, slowed reaction time, and cognitive impairment. Patients with severe anxiety may also be treated with low-dose antiepileptic and antipsychotic medications. Long-term use of the former often leads to abnormal liver function or drug-induced rashes, while the latter can easily cause extrapyramidal symptoms such as involuntary movements and tremors. Furthermore, these medications often result in a relapse or recurrence of anxiety after discontinuation, making a complete cure difficult. Summary of the Invention

[0004] To address the problems existing in the prior art, the present invention provides a traditional Chinese medicine composition for treating anxiety disorder and its application in the preparation of a drug for treating anxiety disorder.

[0005] As one aspect of the present invention, the present invention provides a traditional Chinese medicine composition for treating anxiety disorder, the traditional Chinese medicine composition being made from turmeric, gardenia, lotus seed, chlorite, chicken gizzard lining, and jujube seed.

[0006] Preferably, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 10-40 parts by weight of turmeric, 7-28 parts by weight of gardenia, 7-28 parts by weight of lotus seed, 16-64 parts by weight of chlorite, 4-18 parts by weight of chicken gizzard lining, and 16-64 parts by weight of jujube seed.

[0007] More preferably, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 15-30 parts by weight of turmeric, 10-20 parts by weight of gardenia, 10-20 parts by weight of lotus seed, 22-44 parts by weight of chlorite, 6-14 parts by weight of chicken gizzard lining, and 22-44 parts by weight of jujube seed.

[0008] More preferably, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 18-27 parts by weight of turmeric, 12-18 parts by weight of gardenia, 12-18 parts by weight of lotus seed, 26-39 parts by weight of chlorite, 8-12 parts by weight of chicken gizzard lining, and 26-39 parts by weight of jujube seed.

[0009] Most preferably, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 20 parts by weight of turmeric, 15 parts by weight of gardenia, 15 parts by weight of lotus seed, 30 parts by weight of chlorite, 10 parts by weight of chicken gizzard lining, and 30 parts by weight of jujube seed.

[0010] The traditional Chinese medicine composition described in this invention can be a composition formed by mixing various raw materials after pulverizing them, or it can be an extract obtained by mixing or extracting various raw materials individually, or an effective part obtained by further refining and purifying the extract, or it can be a conventional dosage form made by adding pharmaceutically acceptable excipients to the extract / effective part.

[0011] The extraction methods include decoction extraction, reflux extraction, maceration extraction, ultrasonic extraction, percolation extraction, and microwave extraction; the extraction solvents include one or more of water, methanol, 20-95% ethanol solution, and acetone; the purification methods include water extraction and alcohol precipitation, alkali dissolution and acid precipitation, and various column chromatography purification methods, such as macroporous resin columns, silica gel columns, gel columns, and reversed-phase columns; the conventional dosage forms include, but are not limited to, injections, capsules, tablets, granules, gels, sustained-release agents, oral liquids, pellets, or nano-preparations; the pharmaceutically acceptable excipients include: fillers, disintegrants, lubricants, suspending agents, binders, sweeteners, flavoring agents, preservatives, and matrices. Fillers include: starch, pregelatinized starch, lactose, mannitol, chitosan, microcrystalline cellulose, sucrose, etc.; disintegrants include: starch, pregelatinized starch, microcrystalline cellulose, sodium carboxymethyl starch, croscarmellose, low-substituted hydroxypropyl cellulose, croscarmellose sodium, etc.; lubricants include: magnesium stearate, sodium lauryl sulfate, talc, silica, etc.; suspending agents include: polyvinylpyrrolidone, microcrystalline cellulose, sucrose, agar, hydroxypropyl methylcellulose, etc.; binders include: starch paste, polyvinylpyrrolidone, hydroxypropyl methylcellulose, etc.

[0012] As another aspect of the present invention, the traditional Chinese medicine composition of the present invention may also use an extract of the raw material as a raw material. Therefore, the present invention further provides a traditional Chinese medicine composition for treating anxiety disorder, the traditional Chinese medicine composition being made from the following raw materials:

[0013] Turmeric extract 10-40 parts by weight, Gardenia extract 7-28 parts by weight, Lotus seed extract 7-28 parts by weight, Chrysoprase extract 16-64 parts by weight, Chicken gizzard lining extract 4-18 parts by weight, Ziziphus jujuba seed extract 16-64 parts by weight.

[0014] More preferably, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 15-30 parts by weight of turmeric extract, 10-20 parts by weight of gardenia extract, 10-20 parts by weight of lotus seed extract, 22-44 parts by weight of chlorite extract, 6-14 parts by weight of chicken gizzard lining extract, and 22-44 parts by weight of jujube seed extract.

[0015] More preferably, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 18-27 parts by weight of turmeric extract, 12-18 parts by weight of gardenia extract, 12-18 parts by weight of lotus seed extract, 26-39 parts by weight of chlorite extract, 8-12 parts by weight of chicken gizzard lining extract, and 26-39 parts by weight of jujube seed extract.

[0016] Most preferably, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 20 parts by weight of turmeric extract, 15 parts by weight of gardenia extract, 15 parts by weight of lotus seed extract, 30 parts by weight of chlorite extract, 10 parts by weight of chicken gizzard lining extract, and 30 parts by weight of jujube seed extract.

[0017] The above-mentioned extracts may be aqueous extracts of the active pharmaceutical ingredients, or organic solvent extracts, or refined products obtained by further refining and purification processes of aqueous extracts / organic solvent extracts.

[0018] The organic solvent is selected from one or more of methanol, 20-95% ethanol solution, and acetone;

[0019] The extraction methods used to prepare the above extracts include any one of reflux extraction, maceration extraction, ultrasonic extraction or percolation extraction, or a combination of different extraction methods.

[0020] As another aspect of the present invention, the present invention also provides the use of the traditional Chinese medicine composition in the preparation of a medicament for treating anxiety disorders.

[0021] The beneficial effects of the traditional Chinese medicine composition of this invention:

[0022] This invention, through the combined use of turmeric, gardenia, lotus seed, chlorite, chicken gizzard lining, and jujube seed, can effectively improve the mental and physical anxiety symptoms of patients with anxiety disorders, and can effectively avoid the toxic side effects such as excessive sedation, dizziness, extrapyramidal reactions, drug dependence, and drug tolerance.

[0023] The formulation principle of the herbal composition of this invention: Anxiety is often caused by emotional stagnation and liver fire. Therefore, the key to calming the mind lies first in relieving stagnation. Thus, the chief ingredient of this formula is turmeric, which is bitter, pungent, and cold in nature. It soothes the liver and relieves stagnation, allowing the liver to flow smoothly. This ensures the smooth flow of Qi in the three Jiaos (upper, middle, and lower burners). When the Qi in the upper Jiao flows smoothly, the chest and ribs are not distended; when the Qi in the middle Jiao flows smoothly, the stomach is not distended; and when the Qi in the lower Jiao flows smoothly, bowel movements are regulated. Secondly, it clears heat. Therefore, gardenia is used. It is bitter and cold, clearing heat, relieving irritability, and calming the mind. When the heart fire is cleared, emotions are calmed, irritability is reduced, and depression is relieved. When the liver fire is cleared, irritability, bitter and dry mouth, headache, red eyes, and tinnitus can all be improved. Prolonged stagnation of fire will inevitably deplete liver blood. Therefore, jujube seed is added as an adjuvant. It is sweet and neutral in nature, enters the heart and liver meridians, and is good at nourishing liver blood and calming the liver spirit. Both are used as assistant ingredients. When the liver (wood element) becomes excessive, it inevitably weakens the spleen (earth element). Lotus seeds, sweet and astringent yet neutral in nature, readily enter the heart and spleen meridians. They can strengthen the spleen and stop diarrhea, as well as nourish the blood and calm the mind, thus preventing the liver from overpowering the spleen. When the heart and liver fire are excessive, the mind and spirit become restless. Therefore, chlorite, sweet and salty yet neutral in nature, enters the heart and liver meridians. Its heavy, mineral properties calm the mind and stabilize emotions, thus pacifying the spirit and promoting emotional well-being. Both are used as adjuvant herbs. Chicken gizzard lining, sweet and neutral in nature, strengthens the stomach to prevent the liver from overpowering the spleen and dissolves stones, preventing the heavy chlorite from damaging the stomach. This protects the stomach's qi, thus treating loss of appetite, heartburn, and acid reflux. The combined effects of these herbs clear liver fire, calm the mind, and soothe the spirit.

[0024] Clinical studies have shown that the efficacy rate of the herbal composition of this invention in the second week was 64%, which was significantly better than that of the traditional Western medicine paroxetine hydrochloride. At the end of the trial, the total efficacy rate of the herbal composition of this invention reached 75.2%, which was significantly higher than that of the anti-anxiety Western medicine paroxetine hydrochloride. No side effects such as dizziness, nausea and vomiting, abdominal distension and constipation, or weight gain were observed when taking the herbal composition of this invention. Detailed Implementation

[0025] The present invention is further described below through specific embodiments, but the present invention is not limited to the following embodiments. Modifications, combinations, or substitutions made to the present invention within the scope of the present invention or without departing from the content, spirit, and scope of the present invention will be obvious to those skilled in the art and are included within the scope of the present invention.

[0026] Example 1

[0027] Formula: 20g turmeric, 15g gardenia, 15g lotus seed, 30g chlorite, 10g chicken gizzard lining, 30g jujube seed.

[0028] Take each raw material according to the proportion, crush them, decoct them in water to extract them, and then process the extract into granules using conventional processes.

[0029] Example 2

[0030] Formula: Curcuma longa 19g, Gardenia jasminoides 17g, Nelumbo nucifera 13g, Chlorite 35g, Chicken gizzard lining 9g, Ziziphus jujuba var. spinosa 35g.

[0031] Take the raw materials according to the specified proportions, crush them, and make them into capsules according to conventional pharmaceutical processes.

[0032] Example 3

[0033] Formula: Curcuma longa 23g, Gardenia jasminoides 13g, Nelumbo nucifera 17g, Chlorite 28g, Chicken gizzard lining 11g, Ziziphus jujuba var. spinosa 28g.

[0034] Take the raw materials according to the specified proportions, pulverize them, and make them into tablets according to conventional pharmaceutical processes.

[0035] Example 4

[0036] Formula: 16g turmeric, 19g gardenia, 11g lotus seed, 42g chlorite, 7g chicken gizzard lining, 42g jujube seed.

[0037] Take the raw materials according to the specified proportions, crush them, and make them into pills according to conventional pharmaceutical processes.

[0038] Example 5

[0039] Formula: Curcuma longa 29g, Gardenia jasminoides 11g, Nelumbo nucifera 19g, Chlorite 24g, Chicken gizzard lining 13g, Ziziphus jujuba var. spinosa 24g.

[0040] Take each raw material according to the proportion, decoct in water to extract, and then use the decoction to make an oral liquid according to conventional preparation process.

[0041] Example 6

[0042] Formula: 14g turmeric, 22g gardenia, 9g lotus seed, 50g chlorite, 5g chicken gizzard lining, 50g jujube seed.

[0043] Take each raw material according to the proportion, decoct in water to extract, and then process the decoction into granules according to conventional pharmaceutical processes.

[0044] Example 7

[0045] Formula: 32g turmeric, 9g gardenia, 22g lotus seed, 20g chlorite, 15g chicken gizzard lining, 20g jujube seed.

[0046] Take each raw material according to the proportion, add 75% ethanol and reflux to extract, and make capsules from the extract according to conventional pharmaceutical processes.

[0047] Example 8

[0048] Formula: 11g turmeric, 26g gardenia, 8g lotus seed, 62g chlorite, 4g chicken gizzard lining, 62g jujube seed.

[0049] Take each raw material according to the proportion, add 75% ethanol for reflux extraction, and make tablets from the extract according to conventional pharmaceutical processes.

[0050] Example 9

[0051] Formula: Curcuma longa 38g, Gardenia jasminoides 8g, Nelumbo nucifera 26g, Chlorite 18g, Chicken gizzard lining 17g, Ziziphus jujuba var. spinosa 18g.

[0052] Take each raw material according to the proportion, add 75% ethanol and reflux to extract, and make the extract into pills according to conventional preparation process.

[0053] Example 10

[0054] Formula: 20g turmeric extract, 15g gardenia extract, 15g lotus seed extract, 30g chlorite extract, 10g chicken gizzard lining extract, 30g jujube seed extract.

[0055] Example 11

[0056] Formula: 19g turmeric extract, 17g gardenia extract, 13g lotus seed extract, 35g chlorite extract, 9g chicken gizzard lining extract, 35g jujube seed extract.

[0057] Example 12

[0058] Formula: 23g turmeric extract, 13g gardenia extract, 17g lotus seed extract, 28g chlorite extract, 11g chicken gizzard lining extract, 28g jujube seed extract.

[0059] Example 13

[0060] Formula: 16g turmeric extract, 19g gardenia extract, 11g lotus seed extract, 42g chlorite extract, 7g chicken gizzard lining extract, 42g jujube seed extract.

[0061] Example 14

[0062] Formula: 29g turmeric extract, 11g gardenia extract, 19g lotus seed extract, 24g chlorite extract, 13g chicken gizzard lining extract, and 24g jujube seed extract.

[0063] Example 15

[0064] Formula: 14g turmeric extract, 22g gardenia extract, 9g lotus seed extract, 50g chlorite extract, 5g chicken gizzard lining extract, 50g jujube seed extract.

[0065] Example 16

[0066] Formula: 32g turmeric extract, 9g gardenia extract, 22g lotus seed extract, 20g chlorite extract, 15g chicken gizzard lining extract, 20g jujube seed extract.

[0067] Example 17

[0068] Formula: 11g turmeric extract, 26g gardenia extract, 8g lotus seed extract, 62g chlorite extract, 4g chicken gizzard lining extract, 62g jujube seed extract.

[0069] Example 18

[0070] Formula: 38g turmeric extract, 8g gardenia extract, 26g lotus seed extract, 18g chlorite extract, 17g chicken gizzard lining extract, and 18g jujube seed extract.

[0071] The extracts described in Examples 10-18 above are aqueous extracts of each of the active pharmaceutical ingredients. The extracts are combined according to the formulation amounts and prepared into conventional oral dosage forms such as tablets, capsules, or granules using conventional pharmaceutical processes.

[0072] Example 19 Formulation Screening Experiment

[0073] Formula A: 20g turmeric, 15g gardenia, 15g lotus seed, 30g chlorite, 10g chicken gizzard lining, 30g jujube seed (traditional Chinese medicine composition of this invention);

[0074] Formula B: Gardenia 15g, Lotus seed 15g, Chlorite 30g, Chicken gizzard lining 10g, Ziziphus jujuba seed 30g (The herbal composition of this invention omits the principal herb, Curcuma longa);

[0075] Formula C: Curcuma longa 20g, Scutellaria baicalensis 10g, Nelumbo nucifera 15g, Chlorite 30g, Gallus gallus domesticus gizzard lining 10g, Ziziphus jujuba var. spinosa 30g (the herbal composition of this invention replaces the assistant herb Gardenia jasminoides);

[0076] The above formulas are prepared by taking the raw materials according to the proportions, decocting them in water to extract the extract, and then processing them into granules using conventional processes.

[0077] Sixty patients with generalized anxiety disorder were randomly divided into three groups of 20 each. The patients were treated with medications A, B, and C respectively for a total of 4 weeks. The efficacy of the treatment was evaluated using the generalized anxiety disorder efficacy evaluation criteria.

[0078] The efficacy of the treatment was evaluated based on the reduction rate on the Hamilton Anxiety Rating Scale. Significant differences in efficacy were observed among the three groups after 4 weeks of treatment. The effective rate at week 4 was 76.2% for group A, 62.2% for group B, and 65.4% for group C. The differences among the three groups were statistically significant (P<0.05), with group A > group C > group B.

[0079] The study results showed that group A had significantly better efficacy than groups B and C. This indicates that the compatibility of the herbal composition in this invention is optimal. When the principal herb, turmeric, is removed or the assistant herb, gardenia, is replaced with other herbs, the original compatibility of the formula is disrupted, leading to a significant reduction in the anti-anxiety effect. Therefore, the compatibility of this invention—"turmeric as the principal herb, gardenia and jujube seed as assistant herbs, lotus seed and chlorite as adjuvant herbs, and chicken gizzard lining as the guiding herb"—is a specific choice to achieve the anti-anxiety effect of this invention, which cannot be achieved by other compatibility relationships.

[0080] Example 20 Clinical Efficacy Trial

[0081] From March 2023 to March 2024, 63 patients with generalized anxiety disorder (GAD) were observed at the Third Affiliated Hospital of Beijing University of Chinese Medicine. A randomized, double-blind, parallel-controlled clinical design was used. Patients meeting the inclusion criteria were randomly assigned to three groups: the herbal composition group (prepared according to Example 1) and paroxetine hydrochloride placebo), the control group (herbal composition placebo and paroxetine hydrochloride placebo), and the positive control group (paroxetine hydrochloride and herbal composition placebo). Treatment lasted for 4 weeks. The Hamilton Anxiety Rating Scale and the Traditional Chinese Medicine Syndrome Scale were used to evaluate efficacy and safety at weeks 0, 1, 2, and 4.

[0082] I. Research Plan

[0083] 1. Diagnostic criteria and basis

[0084] 1.1 Diagnostic criteria for generalized anxiety disorder

[0085] Refer to the diagnostic criteria for generalized anxiety disorder in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V).

[0086] 1.2 Diagnostic criteria for generalized anxiety disorder in Traditional Chinese Medicine: Refer to the "Guidelines for the Diagnosis and Treatment of Common Diseases in Traditional Chinese Medicine (TCM) - TCM Diseases and Syndromes Section: Anxiety Disorder"

[0087] 2. Inclusion criteria:

[0088] (1) Age 18 to 65 years old;

[0089] (2) Meets the diagnostic criteria for generalized anxiety disorder;

[0090] (3) Those who have stable vital signs, are conscious, and have a certain ability to express themselves can be selected.

[0091] (4) Educational level: junior high school or above;

[0092] (5) No physical or endocrine diseases;

[0093] (6) Sufficient audiovisual skills are required to complete the necessary examinations for the research;

[0094] (7) The patient and their guardian must give their consent and sign an informed consent form.

[0095] Exclusion criteria:

[0096] (1) Individuals with unstable vital signs;

[0097] (2) Individuals with severe aphasia or agnosia who are unable to communicate;

[0098] (3) Individuals exhibiting certain schizophrenic symptoms;

[0099] (4) Those whose anxiety is clinically diagnosed by Western medicine as a comorbidity of other mental illnesses (such as obsessive-compulsive disorder, schizophrenia, etc.);

[0100] (5) There is evidence that anxiety is causally related to a certain physical illness;

[0101] (6) Patients with recurrent anxiety disorders;

[0102] (7) Known alcoholics or drug addicts;

[0103] If any of the above conditions are met, the applicant will be excluded.

[0104] Exclusion criteria:

[0105] ①Those who were mistakenly included but did not meet the inclusion criteria for anxiety disorder after being selected;

[0106] ②Those who have not taken the experimental drug even once since being selected;

[0107] ③ Those who seriously violate the test protocol.

[0108] The reasons for excluding cases should be stated in the case report form.

[0109] Exit criteria:

[0110] ① If an allergic reaction or serious adverse event occurs, the clinical trial should be stopped, i.e., the patient should withdraw from the clinical trial, based on the doctor's judgment.

[0111] ②Withdraw informed consent from those who consent.

[0112] ③ Those who develop other serious illnesses during the trial.

[0113] ④ Subjects whose blindness was broken during the experiment.

[0114] ⑤ Loss to follow-up.

[0115] ⑥ Poor subject compliance during medication administration, with subjects taking less than 80% of the prescribed dosage or exceeding the prescribed dosage by 120%.

[0116] ⑦ The patient used prohibited drugs or treatments as specified in the treatment plan during the medication process.

[0117] ⑧ The patient becomes agitated or exhibits obvious psychotic symptoms during the experiment.

[0118] 3. Administration method

[0119] Weeks 1-4 (0-28 days):

[0120] The herbal composition of this invention consists of: taking the herbal composition granules of this invention plus paroxetine placebo in the morning and evening respectively;

[0121] Control group: The patient took a placebo of traditional Chinese medicine granules in the morning and a placebo of paroxetine in the evening.

[0122] Positive control group: Paroxetine + Chinese herbal granules placebo were taken in the morning and evening respectively.

[0123] Paroxetine hydrochloride placebo is made by mixing lactose and microcrystalline cellulose in a certain proportion and then compressing them into tablets.

[0124] The placebo of traditional Chinese medicine granules was prepared by adding 10% of the traditional Chinese medicine composition (Example 1) to granule excipients.

[0125] 4. Observation Content, Efficacy Evaluation Indicators, and Detection Methods 4.1 Primary efficacy indicator: Hamilton Anxiety Rating Scale (HAMA). 4.2 Secondary efficacy indicator: Traditional Chinese Medicine Syndrome Scale (see Table 1).

[0126] Table 1. Traditional Chinese Medicine Syndrome Scale for Anxiety Disorder

[0127]

[0128]

[0129] 4.3 Criteria for Evaluating Therapeutic Effect

[0130] 4.3.1 Assessment of scale reduction rate:

[0131] Scale reduction rate = (Pre-treatment score - Post-treatment score) / Pre-treatment score * 100%

[0132] Improvement in patient anxiety was assessed using the reduction in the Hamilton Anxiety Rating Scale (HAMA) score; a reduction rate of ≥50% on the HAMA was considered effective, while <50% was considered ineffective. Anxiety was defined as cured when the post-treatment total HAMA score was ≤7.

[0133] 4.3.2 Criteria for Judging the Therapeutic Effect of Traditional Chinese Medicine Syndromes

[0134] Therapeutic effect index n = (Pre-treatment score - Post-treatment score) / Pre-treatment score × 100%

[0135] Clinical control: Clinical symptoms and signs disappear or basically disappear, and the syndrome score decreases by ≥75%.

[0136] Significant effect: Clinical symptoms and signs are significantly improved, and the syndrome score is reduced by ≥50% <75%.

[0137] Effective: Clinical symptoms and signs improve, and the syndrome score decreases by ≥50% <25%.

[0138] Ineffective: Clinical symptoms and signs show no significant improvement, or even worsen, and the syndrome score decreases by <25%.

[0139] 5. Safety Evaluation

[0140] Safety assessment includes vital signs, physical examination, Treatment Emergent Symptom Scale (TESS), complete blood count, urinalysis, blood biochemistry and electrocardiogram (ECG). Adverse events and serious adverse events will be recorded as other safety and tolerability indicators.

[0141] 6 Statistical Methods

[0142] Descriptive statistical methods were used for data analysis. Quantitative data were described using the number of observations, mean, standard deviation, mode, maximum, and minimum; categorical data were described using the number of observations, frequency, and percentage. Changes in MARS, HAMA, and TCM syndrome scales were analyzed using analysis of covariance; adverse reactions were analyzed using descriptive statistical methods. All statistical tests were two-tailed, and a p-value less than or equal to 0.05 was considered statistically significant. SPSS 18.0 statistical software was used.

[0143] II. Research Results

[0144] 1. General situation

[0145] This study included 63 participants, with 1 dropout and 2 exclusions. The dropout reason was loss to follow-up, and there was no statistically significant difference between the two groups. The exclusion reason was that the patients were taking other medications on their own. A total of 60 participants completed the clinical observation, including 21 males and 39 females. The group consisting of the herbal composition of this invention included 19 participants, the control group included 21 participants, and the positive control group included 20 participants.

[0146] 2. Main therapeutic indicators

[0147] 2.1 Improvement in anxiety

[0148] No significant differences were observed in the reduction rate of the HAMA scale among the three groups at week 1, but significant differences were observed at weeks 2 and 4. The effective rate of the herbal composition of this invention in week 2 was 64%, compared to 40% in the control group and only 37% in the positive control group. At week 4, the mean total effective rate of the herbal composition of this invention was 75.2%, compared to 51% in the control group and 69.1% in the positive control group; the differences among the three groups were significant (P<0.05).

[0149] 2.2 Evaluation of TCM syndrome-based treatment efficacy

[0150] The TCM syndrome efficacy index of the three groups was compared after 1 week, 2 weeks and 4 weeks of treatment. By the end of the 4th week of the experiment, the mean TCM syndrome efficacy index of the herbal composition group of the present invention was 78%, the mean TCM syndrome efficacy index of the control group was 59%, and the mean TCM syndrome efficacy index of the positive control group was 57.1%. The difference among the three groups was significant (P<0.05).

[0151] 2.3 Safety and side effect evaluation

[0152] No abnormalities were found in blood routine tests, liver and kidney function, or other related indicators in any of the enrolled patients before and after treatment in this study. In the Western medicine group, 6 patients experienced mild dizziness, 2 experienced nausea, 1 experienced vomiting, and 3 experienced abdominal distension after taking the medication. No such adverse reactions were observed in the herbal composition of this invention or the control drug group.

[0153] III. Research Conclusions

[0154] The results of this study show that the traditional Chinese medicine composition of the present invention exhibits the following advantages:

[0155] (1) Faster onset of action: The effective rate of the traditional Chinese medicine composition group in the second week was 64%, while that in the Western medicine group was only 37%. This indicates that in terms of anti-anxiety, the traditional Chinese medicine composition of the present invention has the characteristic of faster onset of action compared with the traditional Western medicine paroxetine hydrochloride.

[0156] (2) Good efficacy: At the end of the experiment, the total effective rate of the traditional Chinese medicine composition of the present invention reached 75.2%, which was 6.1 percentage points higher than that of the anti-anxiety drug paroxetine hydrochloride.

[0157] (3) Few side effects: Most anti-anxiety drugs have side effects such as dizziness, nausea and vomiting, abdominal distension and constipation, and weight gain. No such symptoms were observed in the herbal composition of this invention.

Claims

1. A traditional Chinese medicine composition for treating anxiety disorder, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 10-40 parts by weight of turmeric, 7-28 parts by weight of gardenia, 7-28 parts by weight of lotus seed, 16-64 parts by weight of chlorite, 4-18 parts by weight of chicken gizzard lining, and 16-64 parts by weight of jujube seed.

2. The traditional Chinese medicine composition as described in claim 1, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 15-30 parts by weight of turmeric, 10-20 parts by weight of gardenia, 10-20 parts by weight of lotus seed, 22-44 parts by weight of chlorite, 6-14 parts by weight of chicken gizzard lining, and 22-44 parts by weight of jujube seed.

3. The traditional Chinese medicine composition as described in claim 2, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 18-27 parts by weight of turmeric, 12-18 parts by weight of gardenia, 12-18 parts by weight of lotus seed, 26-39 parts by weight of chlorite, 8-12 parts by weight of chicken gizzard lining, and 26-39 parts by weight of jujube seed.

4. The traditional Chinese medicine composition according to claim 3, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 20 parts turmeric, 15 parts gardenia, 15 parts lotus seed, 30 parts chlorite, 10 parts chicken gizzard lining, and 30 parts jujube seed.

5. The traditional Chinese medicine composition according to any one of claims 1-4, characterized in that, The traditional Chinese medicine composition is a composition formed by mixing various raw materials after pulverizing them, or an extract obtained by mixing or extracting various raw materials individually, or an effective part obtained by further refining and purifying the extract, or a conventional dosage form made by adding pharmaceutically acceptable excipients to the extract / effective part.

6. A traditional Chinese medicine composition for treating anxiety, characterized in that, The traditional Chinese medicine composition is made from the following raw materials: 10-40 parts by weight of turmeric extract, 7-28 parts by weight of gardenia extract, 7-28 parts by weight of lotus seed extract, 16-64 parts by weight of chlorite extract, 4-18 parts by weight of chicken gizzard lining extract, and 16-64 parts by weight of jujube seed extract. The extracts are aqueous extracts of each of the active pharmaceutical ingredients.

7. The traditional Chinese medicine composition of claim 6, wherein, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 15-30 parts by weight of turmeric extract, 10-20 parts by weight of gardenia extract, 10-20 parts by weight of lotus seed extract, 22-44 parts by weight of chlorite extract, 6-14 parts by weight of chicken gizzard lining extract, and 22-44 parts by weight of jujube seed extract.

8. The traditional Chinese medicine composition of claim 7, wherein, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 20 parts by weight of turmeric extract, 15 parts by weight of gardenia extract, 15 parts by weight of lotus seed extract, 30 parts by weight of chlorite extract, 10 parts by weight of chicken gizzard lining extract, and 30 parts by weight of jujube seed extract.

9. The use of the traditional Chinese medicine composition according to any one of claims 1-4 and 6-8 in the preparation of a medicament for treating anxiety disorder.

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