Efficacy and Safety of Sipjeondaebo-tang on Korean Patients With Cold Hypersensitivity in the Hands and Feet (SDT)

Gachon University, Gil Oriental Medicine Center

Study Overview

• Status: Completed
• Conditions: Cold Hypersensitivity
• Intervention / Treatment: Drug: Sipjeondaebo-tang Granule; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of
    • Gachon University Gil Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 59 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SDT group; 3g, three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.	Drug: Sipjeondaebo-tang Granule; 3g, three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.; Other Names: Deciten Granule
PLACEBO_COMPARATOR: Placebo group; 3g, three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.	Drug: Placebo; 3g, three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At baseline, week 4, 8, 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from baseline in body temperature	Changes from baseline in body temperature	At baseline, week 4, 8, 12
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.	At baseline, week 4, 8, 12
Changes from baseline in blood pressure	assess for monitoring patient safety	up to 12 weeks
Changes from baseline in Pulse rate	assess for monitoring patient safety	up to 12 weeks
Levels of AST	liver function test for monitoring patient safety(IU/L)	At screening visit, week 8
Levels of ALT	liver function test for monitoring patient safety(IU/L)	At screening visit, week 8
Levels of r-GTP	liver function test for monitoring patient safety(IU/L)	At screening visit, week 8
Levels of BUN	Kidney function test for monitoring patient safety(mmol/L)	At screening visit, week 8
Levels of Cr	Kidney function test for monitoring patient safety(mmol/L)	At screening visit, week 8
complete blood count		At screening visit, week 8
Adverse event		At week 4, 8, 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pattern Identification Questionnaire	This tool is a traditional medicine researcher self-developed questionnaire of screening for patients with Cold Hypersensitivity in the Hands and feet In this trial, we will assess the validity of the tool.	At screening visit

Collaborators and Investigators

• Sponsor: Gachon University Gil Oriental Medical Hospital
• Collaborators: Kyung Hee University Hospital at Gangdong; Kyunghee University Medical Center; Sangji University Oriental Medical Hospital; Semyung University Affiliated Oriental Medical Hospital

Publications and helpful links

General Publications

• Ko Y, Sun SH, Han IS, Go HY, Kim TH, Lee JM, Jang JB, Park KS, Song YK, Lee KY, Jeon CY, Ko SG. The efficacy and safety of Sipjeondaebo-tang in Korean patients with cold hypersensitivity in the hands and feet: a protocol for a pilot, randomized, double-blind, placebo-controlled, parallel-group clinical trial. Trials. 2019 Apr 15;20(1):217. doi: 10.1186/s13063-019-3286-7.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 31, 2018
• Primary Completion (ACTUAL): December 30, 2019
• Study Completion (ACTUAL): December 30, 2019

Study Registration Dates

• First Submitted: November 27, 2017
• First Submitted That Met QC Criteria: December 13, 2017
• First Posted (ACTUAL): December 15, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 1, 2021
• Last Update Submitted That Met QC Criteria: August 30, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Korean medicine; Cold Hypersensitivity; Sipjeondaebo-tang; Cold intolerance
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Genetic Diseases, Inborn; Hereditary Autoinflammatory Diseases; Skin Diseases, Genetic; Hypersensitivity; Cryopyrin-Associated Periodic Syndromes; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Mitosis Modulators; Mitogens; Juzentaihoto
• Other Study ID Numbers: ISEE_2017_SDT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No