KCT0005982尚未招募未知
Effect of Effect of Combined Administration of Pilocarpine and Herbal medicine (Baekhogainsa m-Tang Ext. Granule) on frequent intractable dry mouth: A randomized, open-label, parallel, m ulti-center trial
Kyung Hee University Hospital0 个研究点目标入组 108 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 108
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 80(Year)（—）
- 性别
- All
入选标准
- •1. One or more of the following:
- •History of radiation therapy in the head and neck area
- •Diagnosed as Sjogren's syndrome (the following two conditions are met)
- •-Anti-Ro/SSA test positive
- •-Saliva flow rate (Unstimulated) = 0.1mL/min
- •2. Less than 0.25 ml/min in unstimulated test among salivary flow test (SFR)
- •3. At least 4 points on the Visual Analog Scale for dry mouth for the last 1 month
- •4. Over 19 years old
- •5. Those who agreed in writing to participate in clinical trials
排除标准
- •Exclusion criteria
- •1. Those with the following diseases or history
- •heart failure
- •Patients with systolic blood pressure of 160 mmHg or higher or diastolic blood pressure of 100 mmHg or higher despite treatment with hypertension drugs
- •Patients with or have a history of bronchial asthma
- •arrhythmia
- •Coronary artery (cardiac artery) disease
- •Asthma, chronic bronchitis or chronic obstructive pulmonary disease
- •Congenital amino acid metabolism abnormality
- •There is a risk of intersex coma or intersex coma
- •People with narrow angle glaucoma, peripheral retinopathy, iritis, and other eye diseases where the use of pilocarpine is contraindicated.
- •2. Those taking anticholinergics, antidepressants, ACE inhibitors, ß-adrenergic antagonists, diuretics, anticoagulants, antihistamines, narcotic analgesics, antiplatelet drugs, mineralocorticoids, and digitalis drugs (cardiac drugs)
- •3. A person whose blood test results conducted within 7 days prior to the start date of administration of the investigational drug meet the following criteria:
- •Hemoglobin less than 8.0g/dL
- •AST (GOT) and ALT (GPT) exceeded 3.0 times the upper limit of the laboratory standard
- •Total bilirubin exceeds 2.0 times the upper limit of the laboratory standard
- •Creatinine exceeds the upper limit of 1.5 times the laboratory standard or the creatinine clearance (actual value or estimated by Cockcroft/Gault formula) is less than 60 mL/min.
- •4. Pregnant or breastfeeding persons, persons who have not used appropriate contraception (oral, injection, infusion or hormonal contraception methods, intrauterine devices and blocking methods)
- •5. A person who disagrees with contraception for 4 weeks after the end of administration of the test drug if the male investigator's proper contraception method is not used (both male and female)
- •6. Galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
- •7. Those who have difficulty administering clinical trial drugs orally
- •8. Those who showed clinically significant hypersensitivity to Baekho Gaginsam-tang and its major components
- •9. Those who showed a clinically significant hypersensitivity reaction to pilocarpine
- •10. A person who is judged to be unsuitable for participation in clinical trials based on the judgment of the researcher due to the screening test results and other reasons
- •11. Those with cognitive decline or unable to read or write
研究者
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