Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on sleep in brain health

LIVE: Thursday 2nd May 2024, 18:00-19:30 (CEST)

Quality sleep is essential for health. But what happens to our brains when sleep patterns are disturbed? Join our experts to explore the interplay between sleep disruption and neurological diseases, and the questions that you need to be asking your patients to help you prevent the harmful effects of sleep deprivation.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

Efficacy and safety of Lian-Ju-Gan-Mao capsules for treating the common cold with wind-heat syndrome: study protocol for a randomized controlled trial

Authors: Shengjun Wang, Hongli Jiang, Qin Yu, Bin She, Bing Mao

Published in: Trials | Issue 1/2017

Login to get access

Abstract

Background

The common cold is a common and frequent respiratory disease mainly caused by viral infection of the upper respiratory tract. Chinese herbal medicine has been increasingly prescribed to treat the common cold; however, there is a lack of evidence to support the wide utility of this regimen. This protocol describes an ongoing phase II randomized controlled clinical trial, based on the theory of traditional Chinese medicine (TCM), with the objective of evaluating the efficacy and safety of Lian-Ju-Gan-Mao capsules (LJGMC), a Chinese patent medicine, compared with placebo in patients suffering from the common cold with wind-heat syndrome (CCWHS).

Methods/design

This is a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial. A total of 240 patients will be recruited and randomly assigned to a high-dose group, medium-dose group, low-dose group, and placebo-matched group in a 1:1:1:1 ratio. The treatment course is 3 consecutive days, with a 5-day follow-up. The primary outcome is time to all symptoms’ clearance. Secondary outcomes include time to the disappearance of primary symptoms and each secondary symptom, time to fever relief, time to fever clearance, and change in TCM symptom and sign scores.

Discussion

This trial is a well-designed study according to principles and regulations issued by the China Food and Drug Administration (CFDA). The results will provide high-quality evidence on the efficacy and safety of LJGMC in treating CCWHS and help to optimize the dose for the next phase III clinical trial. Moreover, the protocol presents a detailed and practical methodology for future clinical trials of drugs developed based on TCM.

Trial registration

Chinese Clinical Trial Registry, ChiCTR-IPR-15006504. Registered on 4 June 2015.
Appendix
Available only for authorised users
Literature
1.
Mäkelä MJ, Puhakka T, Ruuskanen O, et al. Viruses and bacteria in the etiology of the common cold. J Clin Microbiol. 1998;36:539-42.PubMedPubMedCentral
2.
Monto AS. Studies of the community and family: acute respiratory illness and infection. Epidemiol Rev. 1994;16:351–73.PubMed
3.
Simasek M, Blandino DA. Treatment of the common cold. Am Fam Physician. 2007;75:515–20.PubMed
4.
Eccles R. Understanding the symptoms of the common cold and influenza. Lancet Infect Dis. 2005;5:718–25.CrossRefPubMed
5.
Bramley TJ, Lerner D, Sames M. Productivity losses related to the common cold. J Occup Environ Med. 2002;44:822–9.CrossRefPubMed
6.
Fendrick AM, Monto AS, Nightengale B, et al. The economic burden of non-influenza-related viral respiratory tract infection in the United States. Arch Intern Med. 2003;163:487–94.CrossRefPubMed
7.
8.
De Sutter AI, van Driel ML, Kumar AA, et al. Oral antihistamine-decongestant-analgesic combinations for the common cold. Cochrane Database Syst Rev. 2012;2:CD004976.
9.
Li S, Yue J, Dong BR, et al. Acetaminophen (paracetamol) for the common cold in adults. Cochrane Database Syst Rev. 2013;7:CD008800.
10.
Picon PD, Costa MB, da Veiga PR, et al. Symptomatic treatment of the common cold with a fixed-dose combination of paracetamol, chlorphenamine and phenylephrine: a randomized, placebo-controlled trial. BMC Infect Dis. 2013;13:556.CrossRefPubMedPubMedCentral
11.
Yakoot M, Salem A. Efficacy and safety of a multiherbal formula with vitamin C and zinc (Immumax) in the management of the common cold. Int J Gen Med. 2011;4:45–51.CrossRefPubMedPubMedCentral
12.
Lissiman E, Bhasale AL, Cohen M. Garlic for the common cold. Cochrane Database Syst Rev. 2014;11:CD006206.
13.
Murdoch DR, Slow S, Chambers ST, et al. Effect of vitamin D3 supplementation on upper respiratory tract infections in healthy adults: the VIDARIS randomized controlled trial. JAMA. 2012;308:1333–9.CrossRefPubMed
14.
Jawad M, Schoop R, Suter A, et al. Safety and efficacy profile of Echinacea purpurea to prevent common cold episodes: a randomized, double-blind, placebo-controlled trial. Evid Based Complement Alternat Med. 2012;2012:841315.CrossRefPubMedPubMedCentral
15.
Wu T, Zhang J, Qiu Y, et al. Chinese medicinal herbs for the common cold. Cochrane Database Syst Rev. 2007;1:CD004782.
16.
Jiao Y, Liu J, Jiang L, et al. Guidelines on common cold for Traditional Chinese Medicine based on pattern differentiation. J Tradit Chin Med. 2013;33:417–22.CrossRefPubMed
17.
He X, Pang X-q, Ye L, et al. Study on the anti-inflammatory, anti-febric and sweat effects of Lian-Ju-Gan-Mao Capsules. Chin J Hosp Pharm. 2011;10:810–3. Article in Chinese.
18.
Zhao P, He X, Wang Y, et al. A study on long-term toxicity of Lian-Ju-Gan-Mao Capsules. J Guiyang Med Coll. 2010;6:558–60. Article in Chinese.
19.
Mo JJ, Xu MD, Yang DD, et al. Experimental study on anti-inflammatory and analgesic effects of ethanol extracts of Dong-medicine Inula cappa. Chin J Exp Tradit Med Form. 2012;18:258–60.
20.
Coon JT, Ernst E. Andrographis paniculata in the treatment of upper respiratory tract infections: a systematic review of safety and efficacy. Planta Med. 2004;70(4):293–8.CrossRefPubMed
21.
Chen HZ. Practice of internal medicine. 14th ed. Beijing: People’s Medical Publishing House Press; 2013.
22.
Zhou ZY. Internal medicine of TCM. 2nd ed. Beijing: The Chinese Medicine Press; 2007.
23.
Li JS, Wang ZW, Li SY, et al. Diagnostic criteria of Traditional Chinese Medicine syndrome and sign for common cold(version 2013). J Tradit Chin Med 2014;55(4):350-51. Article in Chinese
24.
Zhen XY. Guidelines for clinical research of new Chinese medicine. Beijing: China Medical Science Press; 2002.
25.
26.
Zhong YQ, Fu JJ, Liu XM, et al. The reporting quality, scientific rigor, and ethics of randomized placebocontrolled trials of traditional Chinese medicine compound formulations and the differences between Chinese and non-Chinese trials. Curr Ther Res Clin E 2010;71:30–49.CrossRef
27.
Schulz KF, Altman DG, Moher D, for the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c332.
28.
Chan AW, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013;158(3):200–7.CrossRefPubMedPubMedCentral
Metadata
Title
Efficacy and safety of Lian-Ju-Gan-Mao capsules for treating the common cold with wind-heat syndrome: study protocol for a randomized controlled trial
Authors
Shengjun Wang
Hongli Jiang
Qin Yu
Bin She
Bing Mao
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1747-9

Other articles of this Issue 1/2017

Trials 1/2017 Go to the issue

Study protocol

Efficacy of umbilical cord cleansing with a single application of 4% chlorhexidine for the prevention of newborn infections in Uganda: study protocol for a randomized controlled trial

Study protocol

Randomized study exploring the combination of radiotherapy with two types of acupuncture treatment (ROSETTA): study protocol for a randomized controlled trial

Study protocol

Prophylactic Melatonin for Delirium in Intensive Care (Pro-MEDIC): study protocol for a randomised controlled trial

Erratum

Erratum to: A manual-based vocational rehabilitation program for patients with an acquired brain injury: study protocol of a pragmatic randomized controlled trial (RCT)

Study protocol

Integrated mental health care and vocational rehabilitation to improve return to work rates for people on sick leave because of depression and anxiety (the Danish IBBIS trial): study protocol for a randomized controlled trial

Update

COgnitive behavioural therapy versus standardised medical care for adults with Dissociative non-Epileptic Seizures (CODES): statistical and economic analysis plan for a randomised controlled trial