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

NCT03790033 | Completed Phase 2

• 1 other identifier: ISEE_2018_UCHA
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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

Keywords

Cold Hypersensitivity; Korean medicine; Ucha-Shinki-Hwan

Outcome Measures

Primary Outcomes (1)

• Changes from baseline in visual analogue scale(VAS)

  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.

  At baseline, week 4, 8, 12

Secondary Outcomes (10)

• Changes from baseline in body temperature

  At baseline, week 4, 8, 12

• Changes from baseline in WHO Quality of Life-BREF

  At baseline, week 4, 8, 12

• Changes from baseline in blood pressure

  up to 12 weeks

• Changes from baseline in Pulse rate

  up to 12 weeks

• Levels of AST

  At screening visit, week 8

Other Outcomes (1)

• Pattern Identification Questionnaire

  At screening visit

Study Arms (2)

UCHA group

EXPERIMENTAL

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

Drug: Ucha-Shinki-Hwan

Placebo group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Ucha-Shinki-Hwan 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

Also known as: Bosinji

UCHA group

Placebo DRUG

placebo granule

Placebo group

Eligibility Criteria

• Age: 19 Years - 59 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gachon University Gil Oriental Medical Hospital: lead
• Kyunghee University Medical Center: collaborator
• Kyung Hee University Hospital at Gangdong: collaborator
• Semyung University Affiliated Oriental Medical Hospital: collaborator
• Sangji University Oriental Medical Hospital: collaborator

Study Sites (1)

Kyung Hee University medical center at Gangdong

Seoul, 02447, South Korea

Location

Related Publications (1)

• 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.

  PMID: 32080084 DERIVED

MeSH Terms

Conditions

Cold Hypersensitivity

Study Officials

• Chan Yong Jun

  Gachon University Gil Oriental Medicine Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 26, 2018
• First Posted: December 31, 2018
• Study Start: December 11, 2018
• Primary Completion: August 14, 2019
• Study Completion: September 14, 2019
• Last Updated: September 1, 2021

Record last verified: 2021-08

Locations

KR (1)