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Study on metabolomic mechanism of Cold Phenome and Pharmacophenom

Study on metabolomic mechanism of Cold Phenome and Pharmacophenom

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080289
Enrollment
Unknown
Registered
2024-01-25
Start date
2022-05-06
Completion date
Unknown
Last updated
2024-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cold

Interventions

Feng-han Cold Phenome:Treatment with Jingfangbaidu Powder
Feng-re Cold Phenome:Treatment with Yinqiao Powder
Healthy group:None

Sponsors

The Traditional Chinese Medicine Affiliated Hospital of Southwest Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Inclusion criteria for disease group: 1.1 nclusion criteria for Feng-han Cold Phenome (1)Meet the diagnostic criteria of the diagnostic and Zhenghou differentiation for Feng-han Cold based on " traditional chinese internal medicine"and "Standards for the Diagnosis and Efficacy of Chinese Medicine Internal Medicine Diseases(ZY/T001.1-94)". Primary symptom: stuffy nose,thin nasal discharge,aversion to cold,Limb aches and pains. Secondary symptom:sneeze,throat itching,cough,fever,anhidrosis,headache. Tongue manifestation and pulse manifestation:fur is thin white,"floating pulse"or"Floating and tight pulse". Diagnose:?aversion to cold,anhidrosis, or with fever;?stuffy nose,thin nasal discharge; ?headache, or with Limb aches and pains;?"floating pulse"or"Floating and tight pulse" With 2 items in ? and ?, and 1 item in ? or ?. (2)The Feng-han Cold were confirmed by at least 3 chief TCM physicians in a double-blind manner; (3)Duration of disease <48 hours (4)Body temperature =38.5?; (5)Age:18-65 years old, gender is not limited; (6)The patient agreed to participate in the trial and signed the informed consent form to cooperate with the treatment. 1.2nclusion criteria for Feng-re Cold Phenome (1)Meet the diagnostic criteria of the diagnostic and Zhenghou differentiation for Feng-re Cold based on " traditional chinese internal medicine"and "Standards for the Diagnosis and Efficacy of Chinese Medicine Internal Medicine Diseases(ZY/T001.1-94)". Primary symptom: fever,aversion to wind,dryness or pain in throat. Secondary symptom:stuffy nose,nasal discharge,nostril dry or hot,thirst,throat itching,cough. Tongue manifestation and pulse manifestation:red tip of tongue,fur is thin white or thin yellow,floating pulse or rapid pulse. Diagnose:?aversion to wind,or with fever;?stuffy nose,nasal discharge,or with nostril dry or hot;?dizziness or headache,or wih Limb aches and pains.;?thirst;?dryness or pain in throat;?red tip of tongue,fur is thin white or thin yellow,floating pulse or rapid pulse. With 2 items in ? and ?, and 2 items in ????. (2)The Feng-re Cold were confirmed by at least 3 chief TCM physicians in a double-blind manner; (3)Duration of disease <48 hours (4)Body temperature =38.5?; (5)Age:18-65 years old, gender is not limited; (6)The patient agreed to participate in the trial and signed the informed consent form to cooperate with the treatment. 2. Inclusion criteria for the health group: (1) No gender limit, aged 18-65 years; (2) The syndrome differentiation of TCM constitution is peaceful quality; (3) No coronary heart disease, hypertension, kidney disease, tumor and other internal diseases; (4) The subject is informed and agrees to cooperate.

Exclusion criteria

Exclusion criteria: (1) Having been administrating anti-Cold related drugs before the consultation such as antipyretic and analgesic, antiviral, antibiotics, proprietary Chinese medicine; (2) Those who are suffering from allergic diseases such as allergic rhinitis, asthma, etc., or who are allergic to drugs used in this institute; (3) Patients with serious primary diseases such as heart, liver, kidney, hematopoietic system, etc. (4) Those who suffer from mental diseases and cannot guarantee the implementation of the test protocol; (5) Those who have participated in drug clinical trials in the past 1 month; (6) Pregnant or lactating breast-feed nursing women; (7) Those who are considered not suitable as participants by other researchers.

Design outcomes

Primary

MeasureTime frame
Salivary metabolites;

Secondary

MeasureTime frame
Traditional Chinese Medicine Evidence Scale;RNA characterizations of Influenza A & B virus;Differentiation scales of TCM constitutions;Adverse event;

Countries

China

Contacts

Public ContactDayue Darrel DUAN

the Traditional Chinese Medicine Affiliated Hospital of Southwest Medical University

dduan@swmu.edu.cn+86 181 8189 3148

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026