Efficacy and Safety of Ojeok-san on Korean Patients With Cold Hypersensitivity in the Hands and Feet

NCT03083522 | Completed Phase 3 DMC

• 1 other identifier: ISEE_2017_OJS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Cold Hypersensitivity

Keywords

Cold Hypersensitivity; Korean medicine; Ojeok-san; Cold intolerance

Outcome Measures

Primary Outcomes (1)

• Changes from baseline in visual analogue scale

  At baseline, week 4, 8, 12

Secondary Outcomes (8)

• Changes from baseline in body temperature

  At baseline, week 4, 8, 12

• Changes from baseline in WHOQoL-BREF

  At baseline, week 4, 8, 12

• Changes from baseline in cold stress test

  At baseline, week 8

• Vital Sign

  every visit

• Liver function tests

  At screening visit, week 8

Other Outcomes (2)

• Pattern Identification Questionnaire

  At screening visit

• Cold Hypersensitivity diagnostic tool

  At screening visit

Study Arms (2)

OJS group

EXPERIMENTAL

admission to Ojeok-san granule

Drug: Ojeok-San

Placebo Group

PLACEBO COMPARATOR

admission to placebo

Drug: Placebo

Interventions

Ojeok-San DRUG

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

Also known as: OJS

OJS group

Placebo DRUG

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

Also known as: corn starch

Placebo Group

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:

• 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;
• Those who are pregnant (positive urine-HCG) or lactating or have the chances of pregnancy;

Sponsors & Collaborators

• Chan-Yong Jeon: lead
• Kyunghee University Medical Center: collaborator
• Kyung Hee University Hospital at Gangdong: collaborator
• Semyung University Affiliated Oriental Medical Hospital: collaborator

Study Sites (1)

Kyung Hee university medical center

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 30497488 DERIVED

MeSH Terms

Conditions

Cold Hypersensitivity

Interventions

ojeok-san; Starch

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Officials

• Chanyong Jeon, PhD

  Gachon University Gil Oriental Medical Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 14, 2017
• First Posted: March 20, 2017
• Study Start: March 30, 2017
• Primary Completion: August 14, 2019
• Study Completion: November 30, 2019
• Last Updated: January 2, 2020

Record last verified: 2019-12

Locations

KR (1)