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Efficacy and Safety of Sipjeondaebo-tang on Korean Patients With Cold Hypersensitivity in the Hands and Feet (SDT)

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ClinicalTrials.gov Identifier: NCT03374345
Recruitment Status : Recruiting
First Posted : December 15, 2017
Last Update Posted : February 11, 2019
Sponsor:
Collaborators:
Kyunghee University Medical Center
Kyung Hee University Hospital at Gangdong
Semyung University Affiliated Oriental Medical Hospital
Sangji University Oriental Medical Hospital
Information provided by (Responsible Party):
Chan-Yong Jeon, Gachon University Gil Oriental Medical Hospital

Brief Summary:
Gachon University, Gil Oriental Medicine Center

Condition or disease Intervention/treatment Phase
Cold Hypersensitivity Drug: Sipjeondaebo-tang Granule Drug: Placebo Phase 2 Phase 3

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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 Sipjeondaebo-tang on Korean Patients With Cold Hypersensitivity in the Hands and Feet (SDT)
Actual Study Start Date : January 31, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019


Arm Intervention/treatment
Experimental: SDT group
3g, three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.
Drug: Sipjeondaebo-tang Granule
3g, three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.
Other Name: Deciten Granule

Placebo Comparator: Placebo group
3g, three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.
Drug: Placebo
3g, three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.




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


Secondary Outcome Measures :
  1. Changes from baseline in body temperature [ Time Frame: At baseline, week 4, 8, 12 ]
    Changes from baseline in body temperature

  2. Changes from baseline in WHO Quality of Life-BREF [ Time Frame: At baseline, week 4, 8, 12 ]
    It is a international cross-culturally comparable quality of life assessment instrument. The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. There are also two items that are examined separately: Q1 asks about an individuals overall perception of QoL and Q2 asks about an individuals overall perception of their health. The four domain scores denote an individuals perception of QoL in each particular domain. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). The mean score of items within each domain is used to calculate the domain score. Meanscores are then multiplied by 4 in order to make domain scores comparable with the scores used in the WHOQOL-100.

  3. Changes from baseline in blood pressure [ Time Frame: up to 12 weeks ]
    assess for monitoring patient safety

  4. Changes from baseline in Pulse rate [ Time Frame: up to 12 weeks ]
    assess for monitoring patient safety

  5. Levels of AST [ Time Frame: At screening visit, week 8 ]
    liver function test for monitoring patient safety(IU/L)

  6. Levels of ALT [ Time Frame: At screening visit, week 8 ]
    liver function test for monitoring patient safety(IU/L)

  7. Levels of r-GTP [ Time Frame: At screening visit, week 8 ]
    liver function test for monitoring patient safety(IU/L)

  8. Levels of BUN [ Time Frame: At screening visit, week 8 ]
    Kidney function test for monitoring patient safety(mmol/L)

  9. Levels of Cr [ Time Frame: At screening visit, week 8 ]
    Kidney function test for monitoring patient safety(mmol/L)

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

Other Outcome Measures:
  1. Pattern Identification Questionnaire [ 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.


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Ages Eligible for Study:   19 Years to 59 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 able to understand and speak Korean;
  • 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): NCT03374345


Contacts
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Contact: Youme Ko, MA 8229619278 meyougo@khu.ac.kr
Contact: Yeojin Kim, BA 8229619278

Locations
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Korea, Republic of
Gachon University Gil Hospital Recruiting
Incheon, Korea, Republic of
Contact: Heasol Lee, MA         
Sponsors and Collaborators
Gachon University Gil Oriental Medical Hospital
Kyunghee University Medical Center
Kyung Hee University Hospital at Gangdong
Semyung University Affiliated Oriental Medical Hospital
Sangji University Oriental Medical Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chan-Yong Jeon, Principle Investigator, Gachon University Gil Oriental Medical Hospital
ClinicalTrials.gov Identifier: NCT03374345     History of Changes
Other Study ID Numbers: ISEE_2017_SDT
First Posted: December 15, 2017    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Sipjeondaebo-tang
Cold intolerance

Additional relevant MeSH terms:
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Hypersensitivity
Cryopyrin-Associated Periodic Syndromes
Immune System Diseases
Hereditary Autoinflammatory Diseases
Genetic Diseases, Inborn
Skin Diseases, Genetic
Skin Diseases
Juzentaihoto
Antineoplastic Agents
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action