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Cold HypersensitivityPhase 2/3NCT03790033

Efficacy and Safety of Ucha-Shinki-Hwan on Korean Patients With Cold Hypersensitivity in the Hands and Feet-Double Blinded, Randomized, Multicenter, Placebo Controlled Clinical Trial

A Phase 2/3 study testing Ucha-Shinki-Hwan 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

To investigate the efficacy and safety of Ucha-Shinki-Hwan on Korean Patients With Cold Hypersensitivity in the Hands and Feet 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?
Ucha-Shinki-Hwan
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
164 participants
Where
1 siteSouth Korea
Study dates
11 Dec 2018to 14 Sep 2019
Phase
Phase 2/3
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 CHHF.
  • 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

  • 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;
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  • 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 diagnosed with malignant tumor
  • 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

  • Kyung Hee University medical center at Gangdong

    Seoul, 02447

Other trials in South Korea

About this study

To investigate the efficacy and safety of Ucha-Shinki-Hwan on Korean Patients With Cold Hypersensitivity in the Hands and Feet

Being tested
Ucha-Shinki-Hwan, Placebo
Keywords
Cold Hypersensitivity, Korean medicine, Ucha-Shinki-Hwan
Medical subject headings
Cold Hypersensitivity

What participants receive

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

  • Ucha-Shinki-HwanDrug

    Also called Bosinji

    Product name : Bosinji Granule Manufacturer : Tsumura \& Co. Ingredient : Bosinji granule 2.5g (Bosinji extract 1.523g)

    Bosinji extract is composed of following proportion of ingredient

    Rehmannia Root 1.7g Achyranthes Root 1.0g Cornus Fruit 1.0g Dioscorea Rhizome 1.0g Psyllium Husk 1.0g Alisma Rhizome 1.0g Hoelen 1.0g Moutan Root Bark 1.0g Cinnamon Bark 0.3g Pulvis Aconiti Tuberis Purificatum 0.3g

  • PlaceboDrug

    placebo granule

Study groups in NCT03790033
Study groupRoleWhat they receive
UCHA groupExperimental2.5g, three times a day, each taken before or between meals for 8 weeks. Manufacturing company: Shinhwa Pharmaceutical company
Receives: Drug: Ucha-Shinki-Hwan
Placebo groupPlacebo comparator2.5g, three times a day, each taken before or between meals for 8 weeks. Manufacturing company: Tsumura Co., Tokyo, Japan
Receives: Drug: Placebo

What is being measured

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

  1. Changes from baseline in visual analogue scale(VAS)

    The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels.

    Measured: At baseline, week 4, 8, 12

Secondary outcomes (10)

  1. Changes from baseline in body temperature

    Changes from baseline in body temperature

    Measured: At baseline, week 4, 8, 12

  2. Changes from baseline in WHO Quality of Life-BREF

    It is a international cross-culturally comparable quality of life assessment instrument. The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. There are also two items that are examined separately: Q1 asks about an individuals overall perception of QoL and Q2 asks about an individuals overall perception of their health. The four domain scores denote an individuals perception of QoL in each particular domain. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). The mean score of items within each domain is used to calculate the domain score. Meanscores are then multiplied by 4 in order to make domain scores comparable with the scores used in the WHOQOL-100.

    Measured: At baseline, week 4, 8, 12

  3. Changes from baseline in blood pressure

    assess for monitoring patient safety

    Measured: up to 12 weeks

  4. Changes from baseline in Pulse rate

    assess for monitoring patient safety

    Measured: up to 12 weeks

  5. Levels of AST

    liver function test for monitoring patient safety(IU/L)

    Measured: At screening visit, week 8

  6. Levels of ALT

    liver function test for monitoring patient safety(IU/L)

    Measured: Kidney function test for monitoring patient safety(mmol/L)

  7. Levels of r-GTP

    liver function test for monitoring patient safety(IU/L)

    Measured: Kidney function test for monitoring patient safety(mmol/L)

  8. Levels of BUN

    Kidney function test for monitoring patient safety(mmol/L)

    Measured: Kidney function test for monitoring patient safety(mmol/L)

  9. Levels of Cr

    Kidney function test for monitoring patient safety(mmol/L)

    Measured: Kidney function test for monitoring patient safety(mmol/L)

  10. Adverse event

    Measured: At week 4, 8, 12

Timeline

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

  1. First posted31 Dec 2018
  2. Study start11 Dec 2018
  3. Primary completion14 Aug 2019
  4. Study completion14 Sep 2019

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
164 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03790033
Sponsor's protocol ID
ISEE_2018_UCHA
Status last verified
Aug 2021
First submitted
26 Dec 2018
Last updated
1 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: not decided

Publications

  • Ko Y, Sun SH, Go HY, Lee JM, Jang JB, Sung HK, Jang BH, Jeon CY, Ko SG. Efficacy and safety of ucha-shinki-hwan on korean patients with cold hypersensitivity in the hands and feet: Study protocol clinical trial (SPIRIT Compliant). Medicine (Baltimore). 2020 Feb;99(8):e19110. doi: 10.1097/MD.0000000000019110.

    PubMed 32080084

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Ucha-Shinki-Hwan 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 18 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 1 Sep 2021. 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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(VAS) (time frame: At baseline, week 4, 8, 12). 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 NCT03790033, 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 1 Sep 2021.

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