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
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Cold Hypersensitivity
Keywords: Cold Hypersensitivity
Korean medicine
Ucha-Shinki-Hwan
Lead sponsor: Gachon University Gil Oriental Medical Hospital
Sponsor class: OTHER
Collaborators: name: Kyunghee University Medical Center
name: Kyung Hee University Hospital at Gangdong
name: Semyung University Affiliated Oriental Medical Hospital
name: Sangji University Oriental Medical Hospital
First posted: 2018-12-31
Enrollment: 164
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the efficacy and safety of Ucha-Shinki-Hwan on Korean Patients With Cold Hypersensitivity in the Hands and Feet


Eligibility criteria: 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.

Primary outcomes:
measure: Changes from baseline in visual analogue scale(VAS)
timeFrame: At baseline, week 4, 8, 12
Secondary outcomes:
measure: Changes from baseline in body temperature
timeFrame: At baseline, week 4, 8, 12
measure: Changes from baseline in WHO Quality of Life-BREF
timeFrame: At baseline, week 4, 8, 12
measure: Changes from baseline in blood pressure
timeFrame: up to 12 weeks
measure: Changes from baseline in Pulse rate
timeFrame: up to 12 weeks
measure: Levels of AST
timeFrame: At screening visit, week 8
measure: Levels of ALT
timeFrame: Kidney function test for monitoring patient safety(mmol/L)
measure: Levels of r-GTP
timeFrame: Kidney function test for monitoring patient safety(mmol/L)
measure: Levels of BUN
timeFrame: Kidney function test for monitoring patient safety(mmol/L)
measure: Levels of Cr
timeFrame: Kidney function test for monitoring patient safety(mmol/L)
measure: Adverse event
timeFrame: At week 4, 8, 12
Other outcomes:
measure: Pattern Identification Questionnaire
timeFrame: At screening visit
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University medical center at Gangdong
Study officials:
affiliation: Gachon University Gil Oriental Medicine Hospital
name: Chan Yong Jun
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ko Y, Sun SH, Go HY, Lee JM, Jang JB, Sung HK, Jang BH, Jeon CY, Ko SG. Efficacy and safety of ucha-shinki-hwan on korean patients with cold hypersensitivity in the hands and feet: Study protocol clinical trial (SPIRIT Compliant). Medicine (Baltimore). 2020 Feb;99(8):e19110. doi: 10.1097/MD.0000000000019110.