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

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

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

Study Overview

• Status: Completed
• Conditions: Cold Hypersensitivity
• Intervention / Treatment: Drug: Ojeok-San; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Kyung Hee University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 59 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: corn starch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes from baseline in visual analogue scale	At baseline, week 4, 8, 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complete blood count		At screening visit, week 8
Adverse event		At week 4, 8, 12
Changes from baseline in body temperature		At baseline, week 4, 8, 12
Changes from baseline in WHOQoL-BREF		At baseline, week 4, 8, 12
Changes from baseline in cold stress test	similar to the cold stimulation test	At baseline, week 8
Vital Sign	Body temperature, blood pressure, pulse rate	every visit
Liver function tests	Levels of AST, ALT and r-GTP	At screening visit, week 8
Kidney function test	Levels of BUN and Cr	At screening visit, week 8

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pattern Identification Questionnaire	This questionnaire is a traditional medicine researcher self-developed questionnaire for collecting general symptoms of patients with Cold Hypersensitivity in the Hands and feet	At screening visit
Cold Hypersensitivity diagnostic tool	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.	At screening visit

Collaborators and Investigators

• Sponsor: Chan-Yong Jeon
• Collaborators: Kyung Hee University Hospital at Gangdong; Kyunghee University Medical Center; Semyung University Affiliated Oriental Medical Hospital
• Investigators: Study Chair: Chanyong Jeon, PhD, Gachon University Gil Oriental Medical Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 30, 2017
• Primary Completion (ACTUAL): August 14, 2019
• Study Completion (ACTUAL): November 30, 2019

Study Registration Dates

• First Submitted: March 14, 2017
• First Submitted That Met QC Criteria: March 14, 2017
• First Posted (ACTUAL): March 20, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 2, 2020
• Last Update Submitted That Met QC Criteria: December 28, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Korean medicine; Cold Hypersensitivity; Cold intolerance; Ojeok-san
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Genetic Diseases, Inborn; Hereditary Autoinflammatory Diseases; Skin Diseases, Genetic; Hypersensitivity; Cryopyrin-Associated Periodic Syndromes
• Other Study ID Numbers: ISEE_2017_OJS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No