ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03083522
Recruitment Status : Recruiting
First Posted : March 20, 2017
Last Update Posted : April 20, 2018
Sponsor:
Collaborators:
Kyunghee University Medical Center
Kyung Hee University Hospital at Gangdong
Semyung University Affiliated Oriental Medical Hospital
Information provided by (Responsible Party):
Chan-Yong Jeon, Gachon University Gil Oriental Medical Hospital

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

Condition or disease Intervention/treatment Phase
Cold Hypersensitivity Drug: Ojeok-San Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : March 30, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Experimental: OJS group
admission to Ojeok-san granule
Drug: Ojeok-San
Usage: 3g, three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.
Other Name: OJS

Placebo Comparator: Placebo Group
admission to placebo
Drug: Placebo
Usage: 3g three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.
Other Name: corn starch




Primary Outcome Measures :
  1. Changes from baseline in visual analogue scale [ Time Frame: At baseline, week 4, 8, 12 ]

Secondary Outcome Measures :
  1. Changes from baseline in body temperature [ Time Frame: At baseline, week 4, 8, 12 ]
  2. Changes from baseline in WHOQoL-BREF [ Time Frame: At baseline, week 4, 8, 12 ]
  3. Changes from baseline in cold stress test [ Time Frame: At baseline, week 8 ]
    similar to the cold stimulation test

  4. Vital Sign [ Time Frame: every visit ]
    Body temperature, blood pressure, pulse rate

  5. Liver function tests [ Time Frame: At screening visit, week 8 ]
    Levels of AST, ALT and r-GTP

  6. Kidney function test [ Time Frame: At screening visit, week 8 ]
    Levels of BUN and Cr

  7. complete blood count [ Time Frame: At screening visit, week 8 ]
  8. Adverse event [ Time Frame: At week 4, 8, 12 ]

Other Outcome Measures:
  1. Pattern Identification Questionnaire [ Time Frame: At screening visit ]
    This questionnaire is a traditional medicine researcher self-developed questionnaire for collecting general symptoms of patients with Cold Hypersensitivity in the Hands and feet

  2. Cold Hypersensitivity diagnostic tool [ Time Frame: At screening visit ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years to 59 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03083522


Contacts
Contact: Youme Ko, MA 82-2-961-9278 iseeymk@gmail.com

Locations
Korea, Republic of
Kyung Hee university medical center Recruiting
Seoul, Korea, Republic of
Contact: Youme Ko         
Sponsors and Collaborators
Chan-Yong Jeon
Kyunghee University Medical Center
Kyung Hee University Hospital at Gangdong
Semyung University Affiliated Oriental Medical Hospital
Investigators
Study Chair: Chanyong Jeon, PhD Gachon University Gil Oriental Medical Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chan-Yong Jeon, PhD, Gachon University Gil Oriental Medical Hospital
ClinicalTrials.gov Identifier: NCT03083522     History of Changes
Other Study ID Numbers: ISEE_2017_OJS
First Posted: March 20, 2017    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chan-Yong Jeon, Gachon University Gil Oriental Medical Hospital:
Cold Hypersensitivity
Korean medicine
Ojeok-san
Cold intolerance

Additional relevant MeSH terms:
Hypersensitivity
Cryopyrin-Associated Periodic Syndromes
Immune System Diseases
Hereditary Autoinflammatory Diseases
Genetic Diseases, Inborn
Skin Diseases, Genetic
Skin Diseases