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

NCT02645916 | Completed Phase 4

• 1 other identifier: ISEE_2015_DSGOST
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Cold Hypersensitivity

Keywords

Cold Hypersensitivity in the Hands; Korean medicine; DSGOST

Outcome Measures

Primary Outcomes (1)

• Changes from baseline in visual analogue scale

  At baseline, week 2, 4, 6

Secondary Outcomes (4)

• 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

  At baseline, week 6

Study Arms (2)

DSGOST

EXPERIMENTAL

admission to Danggui-Sayuk-Ga-Osuyu-Saenggang-tang granule

Drug: Danggui-Sayuk-Ga-Osuyu-Saenggang-tang

Placebo

PLACEBO COMPARATOR

admission to placebo

Drug: Placebo: corn starch

Interventions

Danggui-Sayuk-Ga-Osuyu-Saenggang-tang DRUG

Usage: 3g, three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM \& FOODS Co. Ltd.

Also known as: DSGOST, Dangsanin Granule

DSGOST

Placebo: corn starch DRUG

Usage: 3g three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM \& FOODS Co. Ltd.

Placebo

Eligibility Criteria

• Age: 19 Years - 59 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female subjects aged 19 to 59 years have a complaint of CHH.
• 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;
• Those who have 4 cm or greater of VAS CHH score;
• A thermal differences between the palm (PC8) and the upper arm (LU4) may be higher than 0.3℃;
• Those who can comply with all study-related procedures, medications, and evaluations;
• Given a written informed consent form.

You may not qualify if:

• We will exclude patients who have taken
• Patients with calcium antagonists or beta-blockers with the purpose of treating CHH;
• Those who have one or more finger gangrene or ulceration;
• Those who are diagnosed by hypothyroidism or currently medicated to thyroid drugs;
• Those who are diagnosed by autoimmune disease or have a positive ANA test result;
• Those who are diagnosed by carpal tunnel syndrome or have a positive Tinel and Phalen's tests;
• Those who are diagnosed with cervical disc herniation or (malignant) tumor disease;
• Those who are diagnosed with diabetes;
• Those who are currently medicated to drugs that may affect to CHH symptoms, such as anticoagulants etc;
• Those who have moderate level of liver dysfunction (each of AST, ALT greater than 100 IU/L) or kidney dysfunction (Cr 2.0mg/dL);
• 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;
• 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);
• 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;
• Those who are suspected arrhythmia that showing up on ECG, or diagnosed by heart diseases, such as, ischemic heart disease and so on;
• Those who are addicted to alcohol or drugs;

Sponsors & Collaborators

• Gachon University Gil Oriental Medical Hospital: lead
• Sangji University Oriental Medical Hospital: collaborator
• Semyung University Affiliated Oriental Medical Hospital: collaborator
• Kyunghee University Medical Center: collaborator
• Kyung Hee University Hospital at Gangdong: collaborator
• DongGuk University: collaborator

Study Sites (1)

Gachon University, Gil Oriental Medicine Center

Incheon, South Korea

Location

Related Publications (1)

• 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.

  PMID: 28595610 DERIVED

MeSH Terms

Conditions

Cold Hypersensitivity

Interventions

DSGOST

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, KMD

Study Record Dates

• First Submitted: December 30, 2015
• First Posted: January 5, 2016
• Study Start: December 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: November 29, 2017

Record last verified: 2017-11

Locations

KR (1)