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Efficacy and Safety of Ojeok-san on Korean Patients With Cold Hypersensitivity in the Hands and Feet (OJS)

Primary Purpose

Cold Hypersensitivity

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ojeok-San
Placebo
Sponsored by
Chan-Yong Jeon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cold Hypersensitivity focused on measuring Cold Hypersensitivity, Korean medicine, Ojeok-san, Cold intolerance

Eligibility Criteria

19 Years - 59 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Female subjects aged 19 to 59 years have a complaint of CHH.

  2. 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;
  3. Those who have 4 cm or greater of VAS CHH score;
  4. A thermal differences between the palm (PC8) and the upper arm (LU4) may be higher than 0.3℃;
  5. Those who can comply with all study-related procedures, medications, and evaluations;
  6. Given a written informed consent form.

Exclusion Criteria:

  1. Patients with calcium antagonists or beta-blockers with the purpose of treating CHH;
  2. Those who have one or more finger gangrene or ulceration;
  3. Those who are diagnosed by hypothyroidism or currently medicated to thyroid drugs;
  4. Those who are diagnosed by autoimmune disease or have a positive ANA test result;
  5. Those who are diagnosed by carpal tunnel syndrome or have a positive Tinel and Phalen's tests;
  6. Those who are diagnosed with cervical disc herniation or (malignant) tumor disease;
  7. Those who are diagnosed with diabetes;
  8. Those who are currently medicated to drugs that may affect to CHH symptoms, such as anticoagulants etc;
  9. Those who have moderate level of liver dysfunction (each of AST, ALT greater than 100 IU/L) or kidney dysfunction (Cr 2.0mg/dL);
  10. 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;
  11. 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);
  12. 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;
  13. Those who are suspected arrhythmia that showing up on ECG, or diagnosed by heart diseases, such as, ischemic heart disease and so on;
  14. Those who are addicted to alcohol or drugs;
  15. Those who are pregnant (positive urine-HCG) or lactating or have the chances of pregnancy;
  16. Those who are diagnosed with malignant tumor
  17. Those who are currently participated in other clinical trials;
  18. Those who are unable to understand and speak Korean;
  19. Those who are judged to be inappropriate for the clinical study by the researchers.

Sites / Locations

  • Kyung Hee university medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

OJS group

Placebo Group

Arm Description

admission to Ojeok-san granule

admission to placebo

Outcomes

Primary Outcome Measures

Changes from baseline in visual analogue scale

Secondary Outcome Measures

Changes from baseline in body temperature
Changes from baseline in WHOQoL-BREF
Changes from baseline in cold stress test
similar to the cold stimulation test
Vital Sign
Body temperature, blood pressure, pulse rate
Liver function tests
Levels of AST, ALT and r-GTP
Kidney function test
Levels of BUN and Cr
complete blood count
Adverse event

Full Information

First Posted
March 14, 2017
Last Updated
December 28, 2019
Sponsor
Chan-Yong Jeon
Collaborators
Kyunghee University Medical Center, Kyung Hee University Hospital at Gangdong, Semyung University Affiliated Oriental Medical Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03083522
Brief Title
Efficacy and Safety of Ojeok-san on Korean Patients With Cold Hypersensitivity in the Hands and Feet
Acronym
OJS
Official Title
Efficacy and Safety of Ojeok-san on Korean Patients With Cold Hypersensitivity in the Hands and Feet - A Randomized, Double-blinded, Placebo Controlled, Multi-center Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
March 30, 2017 (Actual)
Primary Completion Date
August 14, 2019 (Actual)
Study Completion Date
November 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Chan-Yong Jeon
Collaborators
Kyunghee University Medical Center, Kyung Hee University Hospital at Gangdong, Semyung University Affiliated Oriental Medical Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The Purpose of this trial is to investigate the efficacy and safety of Ojeok-san(OJS) on Korean Patients With Cold Hypersensitivity in the Hands

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cold Hypersensitivity
Keywords
Cold Hypersensitivity, Korean medicine, Ojeok-san, Cold intolerance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OJS group
Arm Type
Experimental
Arm Description
admission to Ojeok-san granule
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
admission to placebo
Intervention Type
Drug
Intervention Name(s)
Ojeok-San
Other Intervention Name(s)
OJS
Intervention Description
Usage: 3g, three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
corn starch
Intervention Description
Usage: 3g three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.
Primary Outcome Measure Information:
Title
Changes from baseline in visual analogue scale
Time Frame
At baseline, week 4, 8, 12
Secondary Outcome Measure Information:
Title
Changes from baseline in body temperature
Time Frame
At baseline, week 4, 8, 12
Title
Changes from baseline in WHOQoL-BREF
Time Frame
At baseline, week 4, 8, 12
Title
Changes from baseline in cold stress test
Description
similar to the cold stimulation test
Time Frame
At baseline, week 8
Title
Vital Sign
Description
Body temperature, blood pressure, pulse rate
Time Frame
every visit
Title
Liver function tests
Description
Levels of AST, ALT and r-GTP
Time Frame
At screening visit, week 8
Title
Kidney function test
Description
Levels of BUN and Cr
Time Frame
At screening visit, week 8
Title
complete blood count
Time Frame
At screening visit, week 8
Title
Adverse event
Time Frame
At week 4, 8, 12
Other Pre-specified Outcome Measures:
Title
Pattern Identification Questionnaire
Description
This questionnaire is a traditional medicine researcher self-developed questionnaire for collecting general symptoms of patients with Cold Hypersensitivity in the Hands and feet
Time Frame
At screening visit
Title
Cold Hypersensitivity diagnostic tool
Description
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.
Time Frame
At screening visit

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female subjects aged 19 to 59 years have a complaint of CHH. 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 unable to understand and speak Korean; Those who are judged to be inappropriate for the clinical study by the researchers.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chanyong Jeon, PhD
Organizational Affiliation
Gachon University Gil Oriental Medical Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Kyung Hee university medical center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30497488
Citation
Ko Y, Go HY, Han IS, Lee KY, Kim TH, Lee JM, Jang JB, Song YK, Sun SH, Jeon CY, Ko SG. Efficacy and safety of Ojeok-san in Korean female patients with cold hypersensitivity in the hands and feet: study protocol for a randomized, double-blinded, placebo-controlled, multicenter pilot study. Trials. 2018 Nov 29;19(1):662. doi: 10.1186/s13063-018-3013-9.
Results Reference
derived

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Efficacy and Safety of Ojeok-san on Korean Patients With Cold Hypersensitivity in the Hands and Feet

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