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

NCT ID: NCT03790033

Last Updated: 2021-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-11
• Study Completion Date: 2019-09-14

Brief Summary

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

Conditions

Cold Hypersensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

UCHA group

2.5g, three times a day, each taken before or between meals for 8 weeks. Manufacturing company: Shinhwa Pharmaceutical company

Group Type: EXPERIMENTAL

Ucha-Shinki-Hwan

Intervention Type: DRUG

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

Placebo group

2.5g, three times a day, each taken before or between meals for 8 weeks. Manufacturing company: Tsumura Co., Tokyo, Japan

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo granule

Interventions

Ucha-Shinki-Hwan

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

Intervention Type: DRUG

Placebo

placebo granule

Intervention Type: DRUG

Other Intervention Names

Bosinji

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kyunghee University Medical Center

OTHER

Sponsor Role: collaborator

Kyung Hee University Hospital at Gangdong

OTHER

Sponsor Role: collaborator

Semyung University Affiliated Oriental Medical Hospital

OTHER

Sponsor Role: collaborator

Sangji University Oriental Medical Hospital

UNKNOWN

Sponsor Role: collaborator

Gachon University Gil Oriental Medical Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chan-Yong Jeon

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chan Yong Jun

Role: PRINCIPAL_INVESTIGATOR

Gachon University Gil Oriental Medicine Hospital

Locations

Kyung Hee University medical center at Gangdong

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 32080084 (View on PubMed)

Other Identifiers

ISEE_2018_UCHA

Identifier Type: -

Identifier Source: org_study_id