Status Approved
First Submitted Date
2021/02/19
Registered Date
2021/03/10
Last Updated Date
2021/02/19
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0005982 |
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Unique Protocol ID | KHUH 2020-10-032-003 |
Public/Brief Title | 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 |
Scientific Title | 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 |
Acronym | 다빈도 난치성 구강건조증에 대한 필로카르핀-한약제제(백호가인삼탕) 병용 투여 효과를 검증 |
MFDS Regulated Study | Yes |
IND/IDE Protocol | Yes |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | KHUH 2020-10-032-003 |
Approval Date | 2020-12-14 |
Institutional Review Board Name | Kyung Hee University Hospital IRB |
Institutional Review Board Address | 23, Kyungheedae-ro, Dongdaemun-gu, Seoul |
Institutional Review Board Telephone | 02-958-9579 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Young-Gyu Eun |
Title | MD, PhD |
Telephone | +82-2-958-8474 |
Affiliation | Kyung Hee University Hospital |
Address | Kyungheedaero 23 Dongdaemun-gu, Seoul |
Contact Person for Public Queries | |
Name | Young-Gyu Eun |
Title | MD, PhD |
Telephone | +82-2-958-8474 |
Affiliation | Kyung Hee University Hospital |
Address | Kyungheedaero 23 Dongdaemun-gu, Seoul |
Contact Person for Updating Information | |
Name | Young-Gyu Eun |
Title | MD, PhD |
Telephone | +82-2-958-8474 |
Affiliation | Kyung Hee University Hospital |
Address | Kyungheedaero 23 Dongdaemun-gu, Seoul |
4. Status
Study Site | Multi-center Number of center : 2 | |
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Overall Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2021-05-01 Anticipated | |
Target Number of Participant | 108 | |
Primary Completion Date | 2023-11-30 , Anticipated | |
Study Completion Date | 2023-12-31 , Anticipated | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Inha University Hospital | |
Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2021-05-01 , | |
Recruitment Status by Participating Study Site 2 | ||
Name of Study | Myongji Hospital | |
Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2021-05-01 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Korea Health Industry Development Institute |
Organization Type | Government |
Project ID | HI20C1205020020 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Kyung Hee University Hospital |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | To verify that the combined administration of herbal medicine and low-dose Pilocarpine has a non-inferior effect on the treatment of dry mouth in patients with radiation dry mouth and Sjogren's syndrome compared to the conventional administration of Pilocarpine alone, and alleviates side effects of Pilocarpine. |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Treatment |
Phase | Phase4 |
Intervention Model | Parallel |
Blinding/Masking | Open |
Allocation | RCT |
Intervention Type | Drug |
Intervention Description | 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) : Pilocarpine alone administration • Commercial dose of pilocarpine hydrochloride |
Number of Arms | 2 |
Arm 1 |
Arm Label Combined Administration group |
Target Number of Participant 54 |
|
Arm Type Experimental |
|
Arm Description Pilogen tablet 1 tablet (2.5mg), 4 times a day orally administered for 12 weeks Hanpoong Baekhoga Ginsengtang Extract Granules, 1 packet (4g) once, 3 times a day, orally administered for 12 weeks |
|
Arm 2 |
Arm Label Single administration group |
Target Number of Participant 58 |
|
Arm Type Active comparator |
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Arm Description Pilogen tablet 1 tablet (5mg), 4 times a day, orally administered for 12 weeks |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (K00-K93)Diseases of the digestive system (K11.7)Disturbances of salivary secretion patients with dry mouth |
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Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 19Year~80Year |
|
Description 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 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, β-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 |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | Unstimulated Salivary Flow Rate (SFR) tes |
|
Timepoint | 12 week |
|
Secondary Outcome(s) 1 | ||
Outcome | 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. |
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Timepoint | 12 week |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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