Cold HypersensitivityPhase 4NCT02645916

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

A Phase 4 study testing Danggui-Sayuk-Ga-Osuyu-Saenggang-tang in people with Cold Hypersensitivity, run by Gachon University Gil Oriental Medical Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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 Read more about this study

Who is it for?: Ages 19 to 59 years, women only
Conditions the study is for: Cold Hypersensitivity
What is being tested?: Danggui-Sayuk-Ga-Osuyu-Saenggang-tang
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 66 participants
Where: 1 siteSouth Korea
Study dates: Dec 2015to 1 Aug 2017
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 59 years
Women only
No healthy volunteers
Adult

Who may be able to join

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;

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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.

Who cannot join

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;

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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;
Those who are pregnant (positive urine-HCG) or lactating or have the chances of pregnancy;
Those who are currently participated in other clinical trials;
Those who are able to understand and speak Korean;
Those who are judged to be inappropriate for the clinical study by the researchers.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Gachon University, Gil Oriental Medicine Center
Incheon

Other trials in South Korea

About this study

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
Being tested: Danggui-Sayuk-Ga-Osuyu-Saenggang-tang, Placebo: corn starch
Keywords: Cold Hypersensitivity in the Hands, Korean medicine, DSGOST
Medical subject headings: Cold Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Danggui-Sayuk-Ga-Osuyu-Saenggang-tangDrug
Also called DSGOST, Dangsanin Granule
Usage: 3g, three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM \& FOODS Co. Ltd.
Placebo: corn starchDrug
Usage: 3g three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM \& FOODS Co. Ltd.

Study groups in NCT02645916
Study group	Role	What they receive
DSGOST	Experimental	admission to Danggui-Sayuk-Ga-Osuyu-Saenggang-tang granule Receives: Drug: Danggui-Sayuk-Ga-Osuyu-Saenggang-tang
Placebo	Placebo comparator	admission to placebo Receives: Drug: Placebo: corn starch

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes from baseline in visual analogue scale
Measured: At baseline, week 2, 4, 6

Secondary outcomes (4)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 20151 Aug 2017

First posted5 Jan 2016 (estimated)
Study startDec 2015
Primary completion1 Aug 2017
Study completion1 Aug 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cold HypersensitivityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02645916
Sponsor's protocol ID: ISEE_2015_DSGOST
Status last verified: Nov 2017
First submitted: 30 Dec 2015
Last updated: 29 Nov 2017
Results posted: No
Data monitoring committee: No
Individual data sharing: Undecided

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.
PubMed 28595610

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Phase 1 Study of GTX-B001 in Healthy Subjects and Patients With Chronic Inducible Urticaria
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Active, not recruitingPhase 3
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All Cold Hypersensitivity trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Danggui-Sayuk-Ga-Osuyu-Saenggang-tang on Korean Patients With Cold Hypersensitivity in the Hands
ClinicalTrials.gov ID: NCT02645916
Acronym / sponsor ID: ISEE_2015_DSGOST
Conditions: Cold Hypersensitivity
Keywords: Cold Hypersensitivity in the Hands, Korean medicine, DSGOST
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Gachon University Gil Oriental Medical HospitalUniversity, hospital or other
Collaborators: Sangji University Oriental Medical Hospital, Semyung University Affiliated Oriental Medical Hospital, Kyunghee University Medical Center, Kyung Hee University Hospital at Gangdong, DongGuk University
Study start: Dec 2015
Primary completion: 1 Aug 2017 (actual)
Study completion: 1 Aug 2017 (actual)
First posted: 5 Jan 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
DSGOST	Experimental	Drug: Danggui-Sayuk-Ga-Osuyu-Saenggang-tangadmission to Danggui-Sayuk-Ga-Osuyu-Saenggang-tang granule
Placebo	Placebo comparator	Drug: Placebo: corn starchadmission to placebo

Who may qualify

Ages: 19 to 59 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (9 listed)

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 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;

Key exclusion criteria (19 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Danggui-Sayuk-Ga-Osuyu-Saenggang-tangAlso: DSGOST, Dangsanin GranuleUsage: 3g, three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM \& FOODS Co. Ltd.	Drug	DSGOST
Placebo: corn starchUsage: 3g three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM \& FOODS Co. Ltd.	Drug	Placebo

Primary outcome

Changes from baseline in visual analogue scale
Time frame: At baseline, week 2, 4, 6

4 secondary outcomes

Changes from baseline in body temperature
Time frame: At baseline, week 2, 4, 6
Changes from baseline in clinical global impression(CGI)
Time frame: At baseline, week 2, 4, 6
Changes from baseline in WHOQoL-BREF
Time frame: At baseline, week 2, 4, 6
Changes from baseline in cold stress test
Time frame: At baseline, week 6

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2017.
Derived from this study: PubMed 28595610Ko 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.
Individual participant dataSharing planned: Undecided

Related trials for Cold Hypersensitivity

Not yet recruiting
Evaluating Sucrose and Cold Oral Interventions for the Treatment of Oral Pruritus During Allergy Procedures.
Allergy, Food Allergies
RecruitingPhase 3
A Study to Investigate Efficacy, Safety and Tolerability of Barzolvolimab Versus Placebo in Adults With Cold Induced Urticaria and Symptomatic Dermographism Inadequately Controlled by H1-antihistamines (EMBARQ - ColdU and SD)
Chronic Inducible Urticaria, Cold Urticaria
Active, not recruitingPhase 2
OSE2101 Alone or in Combination With Pembrolizumab vs BSC in Patient With Platinum-sensitive Recurrent OC
Platinum-sensitive Ovarian Cancer, Relapsed Ovarian Cancer
RecruitingPhase 1
A Phase 1 Study of GTX-B001 in Healthy Subjects and Patients With Chronic Inducible Urticaria
Healthy Subjects, Cold Urticaria
Active, not recruitingPhase 3
A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines
Chronic Inducible Urticaria

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Danggui-Sayuk-Ga-Osuyu-Saenggang-tang in people with Cold Hypersensitivity, run by Gachon University Gil Oriental Medical Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes from baseline in visual analogue scale (time frame: At baseline, week 2, 4, 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02645916, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2017.