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About Tasly

Xiaokeqing granules

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Indications: nourishing yin and clearing heat, promoting blood circulation and removing blood stasis. Combined with anti-diabetic chemicals for the treatment of type Ⅱ diabetes with yin deficiency, heat, and blood stasis syndrome; it can improve thirst, drink more food and hungry, fear of heat, upset, excessive redness or urine, and dry stool , Or soreness in the chest, or numbness, tingling, and night sweats.

Approval date: March 03, 2008

Modification date: June 02, 2017

Please read the instructions carefully and use under the guidance of a physician

【Drug Name】

Common name: Xiaokeqing granules

Phonetic script (Hanyu Pinyin): Xiaokeqing Keli

[Ingredients] Zhimu, Atractylodes macrocephala, Coptis chinensis, Puhuang, Dijincao.

[Character] This product is yellow-brown to tan granules; bitter.

[Specifications] 6g per bag

Polyester / aluminum / polyethylene compound packaging film, 9 bags / box. Polyester / aluminum / polyethylene compound film for pharmaceutical packaging, 15 bags / box.

[Dosage and Administration] Warm boiled water. 1 bag at a time, 3 times a day. The course of treatment is 8 weeks.

[Adverse reactions] Nausea and vomiting occurred in individual patients; ALT increased in some patients during medication.

[Contraindications] Disable pregnant women; use with caution in patients with bleeding tendency; use with caution in patients with liver and kidney dysfunction.

[Precautions] Periodically check blood sugar, liver and kidney function while taking the medicine.

【Clinical Trials】

This product was approved by the State Food and Drug Administration (approval number: 2001ZL032) to carry out a multi-center, randomized, double-blind, parallel controlled trial of positive drugs from August 2002 to December 2004. Stage Ⅱ: 118 cases in the test group and 118 cases in the control group; 6 cases were lost in the test group, 2 cases were excluded, 14 cases were lost in the control group, and 4 cases were removed. Stage Ⅲ: 378 cases in the test group and 190 cases in the control group; 19 cases were lost in the test group. There were 10 cases in the control group.

Diagnostic criteria: Western medicine diagnostic criteria for diabetes (using WHO expert consultation report in 1999): fasting venous blood glucose (FPG) ≥7.0mmol / L (126mg / dl); or 2 hours postprandial blood glucose (2HPG) ≥11.1mmol / L (200mg / dl). TCM syndrome differentiation is based on the symptoms of yin deficiency, heat and blood stasis. At the same time the course of disease is more than 3 months. 2 weeks after diet control, exercise therapy, or diet control + exercise therapy + hypoglycemic western medicine treatment.

Observation items: Mainly observe blood glucose (fasting, 2h after meals), TCM syndromes, etc.

Efficacy standards: (1) Fasting blood glucose Significant effect: Fasting blood glucose <7.0mmol / L after treatment, or a decrease of more than 30% before treatment. Effective: Fasting blood glucose <8.3mmol / L after treatment, or decreased by more than 10% before treatment. Ineffective: fasting blood glucose does not meet the above criteria after treatment. (2) 2h postprandial blood glucose was markedly effective: 2h postprandial blood glucose after treatment was <8.3mmol / L, or decreased by more than 30% before treatment. Effective: 2 h postprandial blood glucose after treatment <10.0 mmol / L, or decreased by more than 10% before treatment. Ineffective: The blood glucose after meal 2h after treatment does not meet the above criteria. (3) Judgment criteria for the efficacy of syndromes (Nimodipine method): Significant effect: TCM syndrome scores are reduced by ≥70%. Effective: TCM syndrome scores were reduced by ≥30% and <70%. Invalid: TCM syndrome points are reduced by less than 30%.

Dosage plan: Xiaokeqing granules, warm water, 1 bag once, 3 times a day. Tangmaikang granules, washed with warm water, 1 bag at a time, 3 times a day. 8 weeks is a course of treatment.

Test results: Phase II trial: Fasting blood glucose efficacy (ITT): Among 118 cases in the test group, 46 cases were significantly effective (38.98%), 40 cases were effective (33.90%), 32 cases were ineffective (27.12%); 118 cases in the control group, 36 cases (30.51%) were markedly effective, 40 cases (33.90%) were effective, and 42 cases (35.59%) were ineffective. The two groups had similar effects. Chinese and western medicine combination group: Among the 79 cases in the experimental group, 30 cases were markedly effective (37.97%), 26 cases were effective (32.91%), 23 cases were ineffective (29.12%); and 79 cases in the control group were 22 cases (27.85%) and effective Twenty-six patients (32.91%) and 31 patients (39.24%) who were ineffective were similar. Pure Chinese medicine group: Of the 39 cases in the experimental group, 16 cases were effective (41.02%), 14 cases were effective (35.90%), and 9 cases were ineffective (23.08%). Among the 39 cases in the control group, 14 cases were significantly effective (35.90%) and 14 cases were effective. Cases (35.90%) and 11 cases (28.24%) were ineffective. The two groups had similar effects. 2h postprandial blood glucose effect (ITT): Of the 118 cases in the test group, 48 cases were significantly effective (40.68%), 44 cases were effective (37.29%), 26 cases were ineffective (22.03%); and 118 cases in the control group were 39 cases (33.05). %), 30 cases were effective (25.42%), 49 cases were ineffective (41.53%), which was better than the control. Chinese and western medicine group: Among the 79 cases in the experimental group, 30 cases were markedly effective (37.97%), 28 cases were effective (35.45%), 21 cases were ineffective (26.58%); and 79 cases in the control group were 25 cases (31.65%) and effective 18 cases (22.78%) and 36 cases (45.57%) were ineffective, which was better than the control. Pure Chinese medicine group: Of the 39 cases in the test group, 18 cases were markedly effective (46.15%), 16 cases were effective (41.03%), and 5 cases were ineffective (12.82%). Among the 39 cases in the control group, 14 cases were significantly effective (35.90%) and 14 cases were effective. Cases (35.90%), 11 cases (28.24%) were ineffective, and the two groups had similar efficacy. TCM Syndrome Efficacy (ITT): Among 118 cases in the test group, 40 cases (33.90%) were markedly effective, 68 cases (57.63%) were effective, and 10 cases were not effective (8.47%); among 118 cases in the control group, 42 cases were significantly effective (35.59%). ), 61 cases were effective (51.69%), 15 cases were ineffective (12.72%), and the efficacy was similar in the two groups.

Phase III trial: Fasting blood glucose response (ITT): Of the 378 cases in the test group, 108 cases were significantly effective (28.57%), 110 cases were effective (29.10%), 160 cases were ineffective (42.33%); 46 cases were effective in 190 cases in the control group (24.21%), 52 cases were effective (27.37%), 92 cases were ineffective (48.42%), and the efficacy was similar in the two groups. Chinese and western medicine group: Among the 239 cases in the experimental group, 70 cases were significantly effective (29.29%), 59 cases were effective (24.69%), and 110 cases were ineffective (46.03%). Among the 120 cases in the control group, 28 cases were significantly effective (23.33%) and effective. 29 cases (24.17%) and 63 cases (52.50%) were ineffective. Pure Chinese medicine group: Of the 139 cases in the test group, 38 cases were effective (27.34%), 51 cases were effective (36.69%), and 50 cases were ineffective (35.97%). Among 70 cases in the control group, 18 cases were effective (25.71%) and 23 cases were effective. Cases (32.86%) and 29 cases (41.43%) were ineffective. The two groups had similar effects. 2h postprandial blood glucose (ITT), among the 376 cases in the test group, 106 cases (28.19%) were effective, 135 cases were effective (35.90%), and 135 cases were ineffective (35.90%). Among the 190 cases in the control group, 45 cases were effective (23.68 %), 57 cases were effective (30.00%), 88 cases were ineffective (46.32%), and the efficacy was similar in the two groups. Chinese and western medicine group: Of the 238 cases in the experimental group, 68 cases were significantly effective (28.57%), 78 cases were effective (32.77%), and 92 cases were ineffective (38.66%). Among the 120 cases in the control group, 26 cases were effective (21.67%) and effective. 39 cases (32.50%) and 55 cases (45.83%) were ineffective, which was better than the control. Pure Chinese medicine group: Of the 138 cases in the test group, 38 cases were effective (27.54%), 57 cases were effective (41.30%), and 43 cases were ineffective (31.16%). Among 70 cases in the control group, 19 cases were effective (27.14%), 18 cases were effective (25.71%), 33 cases were ineffective (47.14%), and the efficacy was similar in the two groups. TCM Syndrome Effect (ITT): Of the 378 cases in the test group, 129 cases were markedly effective (34.13%), 209 cases were effective (55.29%), and 40 cases were ineffective (10.58%). Among the 190 cases in the control group, 59 cases were significantly effective (31.05%). ), 105 cases were effective (55.26%), 26 cases were ineffective (13.68%), and the efficacy was similar in the two groups.

The Chinese and western medicine combination group refers to the chemicals used in this test in combination with sulfonylureas, biguanides, α-glucosidase inhibitors, meal glucose regulators, thiazolidinediones, and insulin preparations. During the application of these chemicals, blood glucose was not effectively controlled and additional test drugs were taken at the same time.

Phase Ⅱ: Adverse reactions occurred during medication in both groups of patients. Among them, the adverse reactions in the treatment group (combined Chinese and Western medicine) were: 1 case of nausea, vomiting, and remission after withdrawal; 1 case of diarrhea, remission after withdrawal; the former may be associated with Drug-related, the latter is uncertain. Stage Ⅲ: Those in the experimental group who still had abnormal data after treatment. One case had an increase in ALT, one case with an increase in dyslipidemia, one case with an increase in BUN, one case with urinary infection, and one case with muscle and liver elevation. One case of elevated ALT may be related to the drug.

[Pharmacology and Toxicology]

Animal test results show that this product can reduce the fasting blood glucose value of normal mice and improve the glucose tolerance of normal mice. After long-term administration, it can reduce the blood glucose value of diabetic mice induced by tetraoxopyridine. Prophylactic administration has a certain effect on lowering blood glucose caused by epinephrine in mice; it can reduce the total cholesterol and low-density lipoprotein cholesterol in serum of streptozotocin-induced diabetic rats, and increase the high-density lipoprotein cholesterol in serum, and It can reduce its whole blood viscosity, plasma viscosity, and accelerate the blood circulation speed of the microcirculation of the auricle; it can make the microcirculation blood flow velocity of the eyeball conjunctiva of rabbits caused by high molecular dextran microcirculation disorder.

[Storage] Sealed and kept in a cool (not more than 20 ℃) dry place.

[Packaging] Polyester / aluminum / polyethylene compound packaging film, 9 bags / box.

Polyester / aluminum / polyethylene compound film for pharmaceutical packaging, 15 bags / box.

[Validity] 36 months.

[Executive Standard] State Food and Drug Administration Standard YBZ00432008

[Approval number] National Medicine Standard Z20080034

【manufacturer】