Herbal Medicine 'Eungyosan' and 'Samsoeum' for Common Cold

NCT04073511 | Unknown

• 1 other identifier: 2017012
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 4

Brief Summary

The investigators intend to conduct a multicenter clinical trial to verify the effectiveness and safety of the administration of 'Eungyosan(EGS)' and 'Samsoeum(SSE)' in cold patients.

Conditions

Common Cold

Keywords

Eungyosan; Samsoeum

Outcome Measures

Primary Outcomes (1)

• The chance in total WURSS-21-K(Wisconsin Upper Respiratory Symptom Survey-21 Korean version) score

  The investigators will assess the primary outcome through the change in total score(symptom score sum quality of life score) of Wisconsin Upper Respiratory Symptom Survey-21 Korean version (WURSS-21-K) 6 days after baseline. WURSS-21, which consists of questionnaires regarding gross severity, symptoms, quality of life, and improvement of illness. All items rank on a seven-point scale(1=very mild and 7=severe), where a higher score means higher severity. The symptom score is from 0(Do not have this symptom) to 70, and quality of life score is from 0(Not at all) to 56. Therefore, the total score ranges from 0 to 126.

  6 days (Data collected at different times can be used as a reference)

Secondary Outcomes (4)

• The change in WURSS-21-K(Wisconsin Upper Respiratory Symptom Survey-21 Korean version) symptom score

  6 days (Data collected at different times can be used as a reference)

• The change in WURSS-21-K(Wisconsin Upper Respiratory Symptom Survey-21 Korean version quality of life score

  6 days (Data collected at different times can be used as a reference)

• The duration of cold symptoms

  up to 11 days

• The change in the VAS(Visual Analogue Scale)

  6 days (Data collected at different times can be used as a reference)

Study Arms (3)

Eungyosan

EXPERIMENTAL

Dosage is 1 packet, 2.3g, 3 times daily, 6.9g total daily dose. The total duration of administration is up to 8 days.

Drug: Eungyosan

Samsoeum

EXPERIMENTAL

3.37g of a packet, 3 times a day, the total daily dose is 10.11g. Total duration of administration is up to 8 days.

Drug: Samsoeum

Placebo

PLACEBO COMPARATOR

Take a total of 9.0g, 3.0g each, three times a day. The total duration of administration is up to 8 days.

Drug: Placebo

Interventions

Eungyosan DRUG

This drug is a commercially available drug, manufactured according to the Preparation of granules, General rule of formulation, Korean Pharmacopoeia. Dosage is 1 packet, 2.3g, 3 times daily, 6.9g total daily dose. The total duration of administration is up to 8 days.

Also known as: Hanpoong Eungyosan

Eungyosan

Samsoeum DRUG

This drug is a commercially available drug, manufactured according to MFDS regulations and the Preparation of granules, General rule of formulation, Korean Pharmacopoeia. 3.37g of a packet, 3 times a day, the total daily dose is 10.11g. Total duration of administration is up to 8 days.

Also known as: Hanpoong Samsoeum

Samsoeum

Placebo DRUG

It is composed of lactose carb, corn starch, caramel pigment, and ginseng flavor powder. It is brown granule and made to be recognized as Korean medicine. Take a total of 9.0g, 3.0g each, three times a day. The total duration of administration is up to 8 days.

Placebo

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female aged between 19 and 60 years as of the screening date
• Onset of cold symptoms within 48 hours before screening
• Those who have one or more of the symptoms and related symptoms of runny nose and sore throat (Related symptoms: nasal congestion, sneezing, sore throat, cough, sore throat, headache, chest tightness, fatigue)
• Those who demonstrate understanding of the study details and have willingness to participate as evidenced by voluntary written informed consent
• Those who can be followed up during the clinical trial

You may not qualify if:

• Those who have sinusitis (when the sinus is opaque at the time of examination through the transillumination of the maxillary sinus and the frontal sinus), allergic rhinitis, pneumonia, flu (when coughing or sore throat with sudden fever above 38 ℃), bronchitis, otitis media, tonsillitis (PNS view, Chest Xray test if accurate test is needed)
• Those who have chronic respiratory disease (chronic obstructive pulmonary disease, interstitial lung disease) and asthma
• Those who have taken or should be taking or are taking antibiotics, antivirals, steroids, nasal decongestants, antihistamines, or other medications that are expected to alleviate cold symptoms, or those who have taken food that is expected to relieve cold symptoms within one week of the start of the study
• Those who are being treated for liver cancer or cirrhosis, chronic renal failure, congestive heart failure, etc.
• Those who have systemic disease or autoimmune disease which does not affect cold symptoms
• Those who have severe mental illnesses such as depression or anxiety disorders, or those who are currently taking psychoneurological drugs such as antidepressants
• Drug addicts or alcoholics
• Alanine transaminase (ALT) or aspartate transaminase (AST) exceeds 3 times the upper limit of normal
• Creatinine exceeds twice the upper limit of normal of the research institute
• Weak person (less than body weight index (BMI) 18.5, clinically judged by Korean medical doctor through physical examination)
• Those who have a weak stomach and are considered to be inadequate to take investigational drug (clinically judged by Korean medical doctor through physical examination)
• Those who are with high blood pressure (vital sign measured at upper left after resting for at least 5 minutes at screening: systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥ 100 mmHg) or elderly
• Those who have cardiac disorder or renal disorder (clinically judged by Korean medical doctor through physical examination, ECG, and serum biochemistry)
• Those who have histories of hives, rash, or itching while taking medicines
• Participants in other clinical trials within one month of the start of the trial (30 days prior to the screening visit) or plan to participate in other clinical trials during the trial

Sponsors & Collaborators

• Korean Medicine Hospital of Pusan National University: lead

Study Sites (4)

Korean Medicine Hospital, Pusan National University

Yangsan, Gyeongsangnam-do, 50612, South Korea

Location

Semyung University Korean Medicine Hospital

Jecheon, North Chungcheong, 27136, South Korea

Location

Korean Medicine Hospital of Daejeon University

Daejeon, 35235, South Korea

Location

KyungHee University Medical Center

Seoul, 02447, South Korea

Location

Related Publications (2)

• Kim KI, Hong M, Park YC, Lee BJ, Kim K, Kang BK, Choi JY. Effects of herbal medicines (Eunkyosan/Yin qiao san and Samsoeum/Shen su yin) for treating the common cold: A randomized, placebo-controlled, multicenter clinical trial. Integr Med Res. 2023 Dec;12(4):101005. doi: 10.1016/j.imr.2023.101005. Epub 2023 Oct 26.

  PMID: 38033649 DERIVED

• Kim KI, Hong M, Park YC, Lee BJ, Kim K, Kang BK, Choi JY. Herbal medicines (Eunkyosan and Samsoeum) for treating the common cold: a protocol for a randomized, placebo-controlled, multicenter clinical trial. Integr Med Res. 2020 Mar;9(1):48-53. doi: 10.1016/j.imr.2020.01.009. Epub 2020 Jan 22.

  PMID: 32071868 DERIVED

MeSH Terms

Conditions

Common Cold

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Jun-Yong Choi, PhD

  Korean Medicine Hospital, Pusan National University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun-Yong Choi, PhD

CONTACT

82-55-360-5953; kmd@pusan.ac.kr

Minna Hong, KMD

CONTACT

kmdhminna@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: August 29, 2019
• Study Start: September 16, 2019
• Primary Completion: December 27, 2020
• Study Completion: December 31, 2020
• Last Updated: September 3, 2019

Record last verified: 2019-08

Locations

KR (4)