- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03790033
Efficacy and Safety of Ucha-Shinki-Hwan on Korean Patients With Cold Hypersensitivity in the Hands and Feet-Double Blinded, Randomized, Multicenter, Placebo Controlled Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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Seoul, Korea, Republic of, 02447
- Kyung Hee University medical center at Gangdong
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Female subjects aged 19 to 59 years have a complaint of CHHF.
- Patients must include at least one or more of the following symptoms:
- Those who have the symptoms of CHH in normal temperature which most individuals feel no cold;
- Those who have the symptoms of extremely cold hands in cold temperature exposure;
- Those who are on the return to a warmer environment, the symptoms of cold hands is not completely rewarmed;
- Those who have 4 cm or greater of VAS CHH score;
- A thermal differences between the palm (PC8) and the upper arm (LU4) may be higher than 0.3℃;
- Those who can comply with all study-related procedures, medications, and evaluations;
- Given a written informed consent form.
Exclusion Criteria:
- Patients with calcium antagonists or beta-blockers with the purpose of treating CHH;
- Those who have one or more finger gangrene or ulceration;
- Those who are diagnosed by hypothyroidism or currently medicated to thyroid drugs;
- Those who are diagnosed by autoimmune disease or have a positive ANA test result;
- Those who are diagnosed by carpal tunnel syndrome or have a positive Tinel and Phalen's tests;
- Those who are diagnosed with cervical disc herniation or (malignant) tumor disease;
- Those who are diagnosed with diabetes;
- Those who are currently medicated to drugs that may affect to CHH symptoms, such as anticoagulants etc;
- Those who have moderate level of liver dysfunction (each of AST, ALT greater than 100 IU/L) or kidney dysfunction (Cr 2.0mg/dL);
- Those who do not (cannot) abide by treatment and follow up due to the mental illness such as behavior disorder, depression, anxiety neurosis, schizophrenia, or serious mental illness;
- Those who are Diagnosed with moderate anemia and hematologic disorders (adult non-pregnant women hemoglobin (Hgb) level less than 7g/dL, hematocrit (Hct) level less than 26%, white blood cell (WBC) level greater than 11,000/mm3); Those whose systolic blood pressure (SBP) 180mmHg or diastolic blood pressure (DBP) is greater than 100 mmHg based on average value of at least 2 measurements;
- Those who are suspected arrhythmia that showing up on ECG, or diagnosed by heart diseases, such as, ischemic heart disease and so on;
- Those who are addicted to alcohol or drugs;
- Those who are pregnant (positive urine-HCG) or lactating or have the chances of pregnancy;
- Those who are diagnosed with malignant tumor
- Those who are currently participated in other clinical trials;
- Those who are able to understand and speak Korean;
- Those who are judged to be inappropriate for the clinical study by the researchers.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: UCHA group
2.5g, three times a day, each taken before or between meals for 8 weeks.
Manufacturing company: Shinhwa Pharmaceutical company
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Product name : Bosinji Granule Manufacturer : Tsumura & Co. Ingredient : Bosinji granule 2.5g (Bosinji extract 1.523g) Bosinji extract is composed of following proportion of ingredient Rehmannia Root 1.7g Achyranthes Root 1.0g Cornus Fruit 1.0g Dioscorea Rhizome 1.0g Psyllium Husk 1.0g Alisma Rhizome 1.0g Hoelen 1.0g Moutan Root Bark 1.0g Cinnamon Bark 0.3g Pulvis Aconiti Tuberis Purificatum 0.3g
Other Names:
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PLACEBO_COMPARATOR: Placebo group
2.5g, three times a day, each taken before or between meals for 8 weeks.
Manufacturing company: Tsumura Co., Tokyo, Japan
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placebo granule
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes from baseline in visual analogue scale(VAS)
Time Frame: At baseline, week 4, 8, 12
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The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable.
A patient marks a point on the line that matches the amount of pain he or she feels.
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At baseline, week 4, 8, 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes from baseline in body temperature
Time Frame: At baseline, week 4, 8, 12
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Changes from baseline in body temperature
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At baseline, week 4, 8, 12
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Changes from baseline in WHO Quality of Life-BREF
Time Frame: At baseline, week 4, 8, 12
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It is a international cross-culturally comparable quality of life assessment instrument.
The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment.
There are also two items that are examined separately: Q1 asks about an individuals overall perception of QoL and Q2 asks about an individuals overall perception of their health.
The four domain scores denote an individuals perception of QoL in each particular domain.
Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life).
The mean score of items within each domain is used to calculate the domain score.
Meanscores are then multiplied by 4 in order to make domain scores comparable with the scores used in the WHOQOL-100.
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At baseline, week 4, 8, 12
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Changes from baseline in blood pressure
Time Frame: up to 12 weeks
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assess for monitoring patient safety
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up to 12 weeks
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Changes from baseline in Pulse rate
Time Frame: up to 12 weeks
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assess for monitoring patient safety
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up to 12 weeks
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Levels of AST
Time Frame: At screening visit, week 8
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liver function test for monitoring patient safety(IU/L)
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At screening visit, week 8
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Adverse event
Time Frame: At week 4, 8, 12
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At week 4, 8, 12
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Levels of ALT
Time Frame: Kidney function test for monitoring patient safety(mmol/L)
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liver function test for monitoring patient safety(IU/L)
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Kidney function test for monitoring patient safety(mmol/L)
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Levels of r-GTP
Time Frame: Kidney function test for monitoring patient safety(mmol/L)
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liver function test for monitoring patient safety(IU/L)
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Kidney function test for monitoring patient safety(mmol/L)
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Levels of BUN
Time Frame: Kidney function test for monitoring patient safety(mmol/L)
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Kidney function test for monitoring patient safety(mmol/L)
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Kidney function test for monitoring patient safety(mmol/L)
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Levels of Cr
Time Frame: Kidney function test for monitoring patient safety(mmol/L)
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Kidney function test for monitoring patient safety(mmol/L)
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Kidney function test for monitoring patient safety(mmol/L)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pattern Identification Questionnaire
Time Frame: At screening visit
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This tool is a traditional medicine researcher self-developed questionnaire of screening for patients with Cold Hypersensitivity in the Hands and feet In this trial, we will assess the validity of the tool.
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At screening visit
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Chan Yong Jun, Gachon University Gil Oriental Medicine Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ISEE_2018_UCHA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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