None listed
Conditions
Interventions
Drug : 1.Combined Administration of Pilocarpine and Herbal medicine
: Combination of the following two
• 1/2 dose of pilocarpine hydrochloride
• Baekho Gaginsamtang
2. Control (Conventional Care, CPC)
Sponsors
Kyung Hee University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Unstimulated Salivary Flow Rate (SFR) tes | — |
Secondary
| Measure | Time frame |
|---|---|
| The amount of change and rate of change compared to the baseline value of unstimulated SFR,-The amount of change and rate of change compared to the baseline score of the oral health-related quality of life (OHIP-14: The 14-item Oral Health Impact Profile),-The baseline value of the visual analogue scale (dry mouth) Change amount and rate of change-The amount of change and rate of change compared to baseline values such as the uptake ratio (UR), maximum accumulation (MA), and maximum secretion (MS) of both parotid and submandibular glands by salivary scintigraphy. | — |
Countries
Korea, Republic of
Contacts
Public ContactYoung-Gyu Eun
Kyung Hee University Hospital
Outcome results
None listed