Skip to content

A randomized, double-blind, placebo-controlled, dose-finding, multicenter phase II clinical study on the efficacy and safety of Lianhua Yuping Granules in the treatment of common cold with qi deficiency syndrome

A randomized, double-blind, placebo-controlled, dose-finding, multicenter phase II clinical study on the efficacy and safety of Lianhua Yuping Granules in the treatment of common cold with qi deficiency syndrome

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500106925
Enrollment
Unknown
Registered
2025-07-31
Start date
2025-08-10
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Common cold

Interventions

High-dose Lianhua Yuping Granules:2 bags/time, 3 times/day
Low-dose Lianhua Yuping Granules:2 bags/time, 3 times/day
Lianhua Yuping Granule Simulator:2 bags/time, 3 times/day

Sponsors

Guang'anmen Hospital of Chinese Academy of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Meet the Western medicine common cold diagnosis standards; 2.Meet the Chinese medicine syndrome syndrome of physical deficiency, cold, qi deficiency; 3.Ages 18 to 70 years old (including both ends), and gender is not limited; 4. The course of the disease when randomly enrolled was =2 points during screening; 6. Voluntarily sign a written informed consent form.

Exclusion criteria

Exclusion criteria: 1.Those who combine any of the following: influenza, novel coronavirus infection, mycoplasma infection, herpetic pharyngitis and laryngitis, acute bacterial sinusitis, acute pharyngeal tonsillitis, chronic obstructive pulmonary diseases, asthma, allergic rhinitis, tracheobronchiolitis, pneumonia, upper airway cough syndrome, post-infection cough, gastroesophageal reflux cough and other diseases; 2.The axillary temperature during screening is >38.5?; 3. Blood conventional leukocytes > upper limit of normal reference value, or percentage of neutrophils > upper limit of normal reference value, and the investigator considers a bacterial infection; 4.ALT, AST>1.5 times the upper limit of normal reference value; serum creatinine>upper limit of normal reference value; 5.Used drugs for treating colds or Chinese patent medicines with similar functions and indications to the experimental drugs before screening; 6. There are other serious primary diseases of important organs such as the heart, liver, kidney, blood system, and endocrine system; 7. Pregnant or preparatory women, breastfeeding women; 8.Those who are allergic to the components of the test drug or emergency drugs; 9.Those who suspect or do have a history of alcohol or substance abuse; 10. Participants in other interventional clinical trials within the past 3 months; 11. Those who believe that it is not suitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Proportion of subjects whose symptoms of individual colds disappear/improve;The proportion of subjects whose symptoms of qi deficiency disappear/improve each individual;Change value and rate of change between the Chinese medicine syndrome score scale from baseline;After treatment, the recovery rate, remarkable rate and overall effective rate of TCM syndrome;The overall clinical impression scale-improvement (CGI-I) score is significantly improved;Emergency drug use ratio and dosage;

Secondary

MeasureTime frame
The proportion of subjects who meet the clinical recovery standards after medication;From the first medication to the subjects who meet the clinical recovery standards, the time when the cold symptoms disappear;

Countries

China

Contacts

Public ContactWensheng Qi

Guang'anmen Hospital of Chinese Academy of Traditional Chinese Medicine

qwsqws@sohu.com+86 136 7103 9118

Outcome results

None listed

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