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

Cold Hypersensitivity Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03083522
• Other study ID #: ISEE_2017_OJS
• Status: Completed
• Phase: Phase 3
• Start date: March 30, 2017
• Est. completion date: November 30, 2019

Study information

• Verified date: December 2019
• Source: Gachon University Gil Oriental Medical Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 30, 2019
• Est. primary completion date: August 14, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 59 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cold Hypersensitivity
• Cryopyrin-Associated Periodic Syndromes
• Hypersensitivity

Intervention

Drug:
• Ojeok-San
Usage: 3g, three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.
• Placebo
Usage: 3g three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.

Locations

Country	Name	City	State
Korea, Republic of	Kyung Hee university medical center	Seoul

Sponsors (4)

Lead Sponsor	Collaborator
Chan-Yong Jeon	Kyung Hee University Hospital at Gangdong, Kyunghee University Medical Center, Semyung University Affiliated Oriental Medical Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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