Cold HypersensitivityPhase 3OJSNCT03083522
Efficacy and Safety of Ojeok-san on Korean Patients With Cold Hypersensitivity in the Hands and Feet
A Phase 3 study testing Ojeok-San in people with Cold Hypersensitivity, run by Chan-Yong Jeon at 1 site in South Korea.
Trial summary
The Purpose of this trial is to investigate the efficacy and safety of Ojeok-san(OJS) 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?
- Ojeok-San
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Mar 2017to 30 Nov 2019
- Phase
- Phase 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 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
- 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 unable 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.
About this study
Official title: Efficacy and Safety of Ojeok-san on Korean Patients With Cold Hypersensitivity in the Hands and Feet - A Randomized, Double-blinded, Placebo Controlled, Multi-center Pilot Study
The Purpose of this trial is to investigate the efficacy and safety of Ojeok-san(OJS) on Korean Patients With Cold Hypersensitivity in the Hands
- Conditions
- Cold Hypersensitivity
- Being tested
- Ojeok-San, Placebo
- Keywords
- Cold Hypersensitivity, Korean medicine, Ojeok-san, Cold intolerance
- Medical subject headings
- Cold Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ojeok-SanDrug
Also called OJS
Usage: 3g, three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM \& FOODS Co. Ltd.
PlaceboDrug
Also called corn starch
Usage: 3g three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM \& FOODS Co. Ltd.
| Study group | Role | What they receive |
|---|---|---|
| OJS group | Experimental | admission to Ojeok-san granule Receives: Drug: Ojeok-San |
| Placebo Group | Placebo comparator | admission to placebo Receives: Drug: Placebo |
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 4, 8, 12
Secondary outcomes (8)
Changes from baseline in body temperature
Measured: At baseline, week 4, 8, 12
Changes from baseline in WHOQoL-BREF
Measured: At baseline, week 4, 8, 12
Changes from baseline in cold stress test
similar to the cold stimulation test
Measured: At baseline, week 8
Vital Sign
Body temperature, blood pressure, pulse rate
Measured: every visit
Liver function tests
Levels of AST, ALT and r-GTP
Measured: At screening visit, week 8
Kidney function test
Levels of BUN and Cr
Measured: At screening visit, week 8
complete blood count
Measured: At screening visit, week 8
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.
- First posted20 Mar 2017
- Study start30 Mar 2017
- Primary completion14 Aug 2019
- Study completion30 Nov 2019
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chan-Yong Jeon
- Sponsor type
- University, hospital or other
- Collaborators
- Kyunghee University Medical Center, Kyung Hee University Hospital at Gangdong, Semyung University Affiliated Oriental Medical Hospital
- Responsible party
- Sponsor-investigator, Chan-Yong Jeon, Gachon University Gil Oriental Medical Hospital
- Investigators
- Chanyong Jeon, PhD, Study chair, Gachon University Gil Oriental Medical Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03083522
- Sponsor's protocol ID
- ISEE_2017_OJS
- Acronym
- OJS
- Status last verified
- Dec 2019
- First submitted
- 14 Mar 2017
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ko Y, Go HY, Han IS, Lee KY, Kim TH, Lee JM, Jang JB, Song YK, Sun SH, Jeon CY, Ko SG. Efficacy and safety of Ojeok-san in Korean female patients with cold hypersensitivity in the hands and feet: study protocol for a randomized, double-blinded, placebo-controlled, multicenter pilot study. Trials. 2018 Nov 29;19(1):662. doi: 10.1186/s13063-018-3013-9.
PubMed 30497488
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Ojeok-san on Korean Patients With Cold Hypersensitivity in the Hands and Feet - A Randomized, Double-blinded, Placebo Controlled, Multi-center Pilot Study
- ClinicalTrials.gov ID
- NCT03083522
- Acronym / sponsor ID
- OJS / ISEE_2017_OJS
- Conditions
- Cold Hypersensitivity
- Keywords
- Cold Hypersensitivity, Korean medicine, Ojeok-san, Cold intolerance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chan-Yong JeonUniversity, hospital or other
- Collaborators
- Kyunghee University Medical Center, Kyung Hee University Hospital at Gangdong, Semyung University Affiliated Oriental Medical Hospital
- Study start
- 30 Mar 2017 (actual)
- Primary completion
- 14 Aug 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 20 Mar 2017 (actual)
- 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 Ojeok-san(OJS) on Korean Patients With Cold Hypersensitivity in the Hands
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OJS group | Experimental | Drug: Ojeok-Sanadmission to Ojeok-san granule |
| Placebo Group | Placebo comparator | Drug: Placeboadmission 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)
- 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;
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 |
|---|---|---|
| Ojeok-SanAlso: OJSUsage: 3g, three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM \& FOODS Co. Ltd. | Drug | OJS group |
| PlaceboAlso: corn starchUsage: 3g three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM \& FOODS Co. Ltd. | Drug | Placebo Group |
Primary outcome
Changes from baseline in visual analogue scale
Time frame: At baseline, week 4, 8, 12
8 secondary outcomes
Changes from baseline in body temperature
Time frame: At baseline, week 4, 8, 12
Changes from baseline in WHOQoL-BREF
Time frame: At baseline, week 4, 8, 12
Changes from baseline in cold stress test
Time frame: At baseline, week 8
Vital Sign
Time frame: every visit
Liver function tests
Time frame: At screening visit, week 8
Kidney function test
Time frame: At screening visit, week 8
complete blood count
Time frame: At screening visit, week 8
Adverse event
Time frame: At week 4, 8, 12
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 2 Jan 2020.
- Derived from this study: PubMed 30497488Ko Y, Go HY, Han IS, Lee KY, Kim TH, Lee JM, Jang JB, Song YK, Sun SH, Jeon CY, Ko SG. Efficacy and safety of Ojeok-san in Korean female patients with cold hypersensitivity in the hands and feet: study protocol for a randomized, double-blinded, placebo-controlled, multicenter pilot study. Trials. 2018 Nov 29;19(1):662. doi: 10.1186/s13063-018-3013-9.
- Individual participant dataSharing planned: Undecided
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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
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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.
Chanyong Jeon, PhD study chair
Gachon University Gil Oriental Medical Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ojeok-San in people with Cold Hypersensitivity, run by Chan-Yong Jeon 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 2 Jan 2020. 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 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 (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 NCT03083522, 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 2 Jan 2020.