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

Phase 3

Completed

• Conditions: Cold Hypersensitivity
• Interventions: Drug: Ojeok-San; Drug: Placebo

• Registration Number: NCT03083522
• Lead Sponsor: Chan-Yong Jeon

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-14
• Study First Submitted QC: 2017-03-14
• Study First Posted: 2017-03-20
• Study Start: 2017-03-30
• Primary Completion: 2019-08-14
• Study Completion: 2019-11-30
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-28
• Last Update Posted: 2020-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OJS group	Ojeok-San	admission to Ojeok-san granule
Placebo Group	Placebo	admission to placebo

Primary Outcome Measures

Name	Time	Method
Changes from baseline in visual analogue scale	At baseline, week 4, 8, 12

Secondary Outcome Measures

Name	Time	Method
Liver function tests	At screening visit, week 8	Levels of AST, ALT and r-GTP
complete blood count	At screening visit, week 8
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	At baseline, week 8	similar to the cold stimulation test
Vital Sign	every visit	Body temperature, blood pressure, pulse rate
Adverse event	At week 4, 8, 12
Kidney function test	At screening visit, week 8	Levels of BUN and Cr

Trial Locations

Locations (1)

Kyung Hee university medical center; 🇰🇷 Seoul, Korea, Republic of