A Multi-Center Clinical Trial To Evaluate Chinese Herbal Medicines in the Treatment of Severe Hand-foot-mouth Disease

NCT ID: NCT01145664

Last Updated: 2010-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

390 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Brief Summary

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The aim of this study is to evaluate the effectiveness and safety of Chinese herbal medicines for severe hand-foot-mouth disease.

Detailed Description

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Conditions

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Hand, Foot and Mouth Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Western therapy

Group Type ACTIVE_COMPARATOR

Western therapy

Intervention Type DRUG

Intervention time: 7-10 days; Follow-up time: 5 days.

Herbal concentrate-granules plus western therapy

Group Type EXPERIMENTAL

Herbal concentrate-granules plus western therapy

Intervention Type DRUG

Intervention time: 7-10 days; Follow-up time: 5 days.

Reduning Injection plus western therapy

Group Type EXPERIMENTAL

Reduning Injection plus western therapy

Intervention Type DRUG

Intervention time: 7-10 days; Follow-up time: 5 days.

Interventions

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Herbal concentrate-granules plus western therapy

Intervention time: 7-10 days; Follow-up time: 5 days.

Intervention Type DRUG

Reduning Injection plus western therapy

Intervention time: 7-10 days; Follow-up time: 5 days.

Intervention Type DRUG

Western therapy

Intervention time: 7-10 days; Follow-up time: 5 days.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Clinical diagnosis of severe hand-foot-mouth disease patients according to hand-foot-mouth disease treatment guidelines 2010 issued by China's Ministry of Health
2. not more than 24 hours of occurrence of severe symptoms
3. age of 1-13 years
4. Patients or their guardians agree to participate in this study and signed the informed consent form

Exclusion Criteria

1. Suffering from neurogenic pulmonary edema, heart or lung failure.
2. Complicated with other serious diseases such as chronic hepatitis, congenital heart disease, acute or chronic nephritis and blood diseases, etc
3. the history of allergies on Chinese medicine
4. the history of mild increase of blood bilirubin hemolysis (or uric bravery former positive) phenomenon
5. using hormonal therapy
6. Attending other clinical studies on hand-foot-mouth disease
7. Patients or their guardians suffering from mental illness
Minimum Eligible Age

1 Year

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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State Administration of Traditional Chinese Medicine of the People's Republic of China

OTHER_GOV

Sponsor Role collaborator

China Academy of Chinese Medical Sciences

OTHER

Sponsor Role collaborator

Beijing University of Chinese Medicine

OTHER

Sponsor Role collaborator

Beijing YouAn Hospital

OTHER

Sponsor Role lead

Responsible Party

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Beijing YouAn Hospital,Capital Medical University

Locations

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Guangzhou Women and Children Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Site Status RECRUITING

Kaifeng Municipal Children's Hospital

Kaifeng, Henan, China

Site Status RECRUITING

Hunan Provincial Children's Hospital

Changsha, Hunan, China

Site Status RECRUITING

Anhui Provincial Children's Hospital

Anhui, , China

Site Status RECRUITING

Beijing YouAn Hospital,Capital Medical University

Beijing, , China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Yi Xu

Role: primary

13416427315

Dan Wei

Role: primary

13977166581

Xi Zhang

Role: primary

13069307700

Shuangjie Li

Role: primary

15874162057

Biquan Chen

Role: primary

13856065978

Xiuhui li, MD

Role: primary

86-10-93997040

References

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Li XH, Li SJ, Xu Y, Wei D, Shi QS, Zhu QX, Yang T, Ding JB, Tian YM, Huang JH, Wang K, Wen T, Zhang X. Effect of integrated Chinese and Western medicine therapy on severe hand, foot and mouth disease: A prospective, randomized, controlled trial. Chin J Integr Med. 2017 Dec;23(12):887-892. doi: 10.1007/s11655-016-2504-3. Epub 2016 Jul 9.

Reference Type DERIVED
PMID: 27392481 (View on PubMed)

Other Identifiers

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200907001-3

Identifier Type: -

Identifier Source: org_study_id

NCT01314794

Identifier Type: -

Identifier Source: nct_alias

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