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

Common Cold Clinical Trial

Official title:

The Effectiveness and Safety of 'Eungyosan' and 'Samsoeum' for Common Cold - a Randomized, Parallel-group, Placebo-controlled, Multicenter Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04073511
• Other study ID #: 2017012
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 16, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: August 2019
• Source: Korean Medicine Hospital of Pusan National University
• Contact: Jun-Yong Choi, PhD
• Phone: 82-55-360-5953
• Email: kmd[@]pusan.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

375 participants with symptoms of the common cold within 48 h will be recruited for this randomized, placebo-controlled trial. Subjects who will participate in the study will be divided into three groups, 'Eungyosan' group(EGS), 'Samsoeum' group(SSE) and placebo group according to the randomization number. Each group of subjects will take the drugs(EGS or SSE or placebo) 3 times a day up to 8 days.

The severity of illness will be assessed by Wisconsin Upper Respiratory Symptom Survey-21 Korean version (WURSS-21-K) and the VAS(visual analog scale) every 8days. Also, the duration of the common cold will be checked to evaluate the effectiveness.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 375
• Est. completion date: December 31, 2020
• Est. primary completion date: December 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Male and female aged between 19 and 60 years as of the screening date

2. Onset of cold symptoms within 48 hours before screening

3. 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)

4. Those who demonstrate understanding of the study details and have willingness to participate as evidenced by voluntary written informed consent

5. Those who can be followed up during the clinical trial

6. Those who do not meet the exclusion criteria

Exclusion Criteria:

1. 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)

2. Those who have chronic respiratory disease (chronic obstructive pulmonary disease, interstitial lung disease) and asthma

3. 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

4. Those who are being treated for liver cancer or cirrhosis, chronic renal failure, congestive heart failure, etc.

5. Those who have systemic disease or autoimmune disease which does not affect cold symptoms

6. Those who have severe mental illnesses such as depression or anxiety disorders, or those who are currently taking psychoneurological drugs such as antidepressants

7. Drug addicts or alcoholics

8. Alanine transaminase (ALT) or aspartate transaminase (AST) exceeds 3 times the upper limit of normal

9. Creatinine exceeds twice the upper limit of normal of the research institute

10. Weak person (less than body weight index (BMI) 18.5, clinically judged by Korean medical doctor through physical examination)

11. 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)

12. 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

13. Those who have cardiac disorder or renal disorder (clinically judged by Korean medical doctor through physical examination, ECG, and serum biochemistry)

14. Those who have histories of hives, rash, or itching while taking medicines

15. 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

16. Pregnant women or women who may be pregnant

17. Those who do not agree to contraception in case of women of childbearing age

18. Those who are being held in group facilities such as social welfare facilities

19. Those who are inappropriate to participate in the trial by the investigator's judgment

20. Those who have hypersensitivity to the investigational drug (main ingredient and its components)

21. Those who have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption

22. Those who have hypokalemia

23. Those who have difficulty in daily life due to sweats (excessive sweating, general weakness, etc.)

24. Those who have difficulty in daily life due to anorexia, nausea or vomiting

25. Those who are suspected of having pneumonia and need antibiotic treatment or those who are receiving medical treatment (those receiving other medications)

Related Conditions & MeSH terms

• Common Cold

Intervention

Drug:
• Eungyosan
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.
• Samsoeum
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.
• Placebo
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.

Locations

Country	Name	City	State
Korea, Republic of	Korean Medicine Hospital of Daejeon University	Daejeon
Korea, Republic of	Semyung University Korean Medicine Hospital	Jecheon	Chungcheongbuk-do
Korea, Republic of	KyungHee University Medical Center	Seoul
Korea, Republic of	Korean Medicine Hospital, Pusan National University	Yangsan	Gyeongsangnam-do

Sponsors (1)

Lead Sponsor	Collaborator
Korean Medicine Hospital of Pusan National University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The change in WURSS-21-K(Wisconsin Upper Respiratory Symptom Survey-21 Korean version) symptom score	The investigators will assess the secondary outcome through the change in symptom score of Wisconsin Upper Respiratory Symptom Survey-21 Korean version (WURSS-21-K) 6 days after baseline. All items of symptom score rank on a seven-point scale(1=very mild and 7=severe), where a higher score means higher severity. The symptom score ranges from 0(Do not have this symptom) to 70.	6 days (Data collected at different times can be used as a reference)
Secondary	The change in WURSS-21-K(Wisconsin Upper Respiratory Symptom Survey-21 Korean version quality of life score	The investigators will assess the secondary outcome through the change in quality of life score of Wisconsin Upper Respiratory Symptom Survey-21 Korean version (WURSS-21-K) 6 days after baseline. All items of quality of life score rank on a seven-point scale(1=very mildly and 7=severely), where a higher score means higher severity. The quality of life score ranges from 0(Not at all) to 56.	6 days (Data collected at different times can be used as a reference)
Secondary	The duration of cold symptoms	The duration of cold symptoms	up to 11 days
Secondary	The change in the VAS(Visual Analogue Scale)	The investigators will assess the secondary outcome through the change in the VAS(Visual analog scale) 6 days after baseline, using EuroQol-visual analog scales(EQ-VAS). The EQ-VAS is a vertical visual analog scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which participants provide a global assessment of their health.	6 days (Data collected at different times can be used as a reference)