Efficacy and Safety of Danggui-Sayuk-Ga-Osuyu-Saenggang-tang on Korean Patients With Cold Hypersensitivity in the Hands

Cold Hypersensitivity Clinical Trial

Official title:

Efficacy and Safety of Danggui-Sayuk-Ga-Osuyu-Saenggang-tang on Korean Patients With Cold Hypersensitivity in the Hands

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02645916
• Other study ID #: ISEE_2015_DSGOST
• Status: Completed
• Phase: Phase 4
• First received: December 30, 2015
• Last updated: November 27, 2017
• Start date: December 2015
• Est. completion date: August 1, 2017

Study information

• Verified date: November 2017
• 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 Danggui-Sayuk-Ga-Osuyu-Saenggang-tang(DSGOST) on Korean Patients With Cold Hypersensitivity in the Hands

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: August 1, 2017
• Est. primary completion date: August 1, 2017
• 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:

We will exclude patients who have taken

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 currently participated in other clinical trials;

17. Those who are able to understand and speak Korean;

18. 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:
• Danggui-Sayuk-Ga-Osuyu-Saenggang-tang
Usage: 3g, three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.
• Placebo: corn starch
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	Gachon University, Gil Oriental Medicine Center	Incheon

Sponsors (6)

Lead Sponsor	Collaborator
Gachon University Gil Oriental Medical Hospital	Dongguk University Ilsan Oriental Hospital, Kyung Hee University Hospital at Gangdong, Kyunghee University Oriental Medical Center, Sangji University Oriental Medical Hospital, Semyung University second affiliated oriental medical hospital at Chungju

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline in visual analogue scale		At baseline, week 2, 4, 6
Secondary	Changes from baseline in body temperature		At baseline, week 2, 4, 6
Secondary	Changes from baseline in clinical global impression(CGI)		At baseline, week 2, 4, 6
Secondary	Changes from baseline in WHOQoL-BREF		At baseline, week 2, 4, 6
Secondary	Changes from baseline in cold stress test	similar to the cold stimulation test	At baseline, week 6