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

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

Study Overview

• Status: Completed
• Conditions: Cold Hypersensitivity
• Intervention / Treatment: Drug: Danggui-Sayuk-Ga-Osuyu-Saenggang-tang; Drug: Placebo: corn starch

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of
    • Gachon University, Gil Oriental Medicine Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 57 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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DSGOST; admission to Danggui-Sayuk-Ga-Osuyu-Saenggang-tang granule	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.; Other Names: DSGOST; Dangsanin Granule
Placebo Comparator: Placebo; admission to placebo	Drug: Placebo: corn starch; Usage: 3g three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes from baseline in visual analogue scale	At baseline, week 2, 4, 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from baseline in body temperature		At baseline, week 2, 4, 6
Changes from baseline in clinical global impression(CGI)		At baseline, week 2, 4, 6
Changes from baseline in WHOQoL-BREF		At baseline, week 2, 4, 6
Changes from baseline in cold stress test	similar to the cold stimulation test	At baseline, week 6

Collaborators and Investigators

• Sponsor: Gachon University Gil Oriental Medical Hospital
• Collaborators: Kyung Hee University Hospital at Gangdong; DongGuk University; Kyunghee University Medical Center; Sangji University Oriental Medical Hospital; Semyung University Affiliated Oriental Medical Hospital

Publications and helpful links

General Publications

• Ko Y, Go HY, Cho YY, Shin JH, Kim TH, Choi DJ, Lee JM, Jang JB, Song YK, Ko SG, Sun SH, Jeon CY. The efficacy and safety of Danggui-Sayuk-Ga-Osuyu-Saenggang-tang on Korean patients with cold hypersensitivity in the hands: study protocol for a pilot, double-blind, randomized, placebo-controlled, parallel-group clinical trial. Trials. 2017 Jun 8;18(1):268. doi: 10.1186/s13063-017-2002-8.

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: December 30, 2015
• First Submitted That Met QC Criteria: January 4, 2016
• First Posted (Estimate): January 5, 2016

Study Record Updates

• Last Update Posted (Actual): November 29, 2017
• Last Update Submitted That Met QC Criteria: November 27, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Korean medicine; Cold Hypersensitivity in the Hands; DSGOST
• 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_2015_DSGOST

Plan for Individual participant data (IPD)

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