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'Taiji' Huoxiang zhengqi Oral liquid in the treatment of gastrointestinal type cold: a randomized, double-blind, placebo parallel control, multicenter clinical trial

'Taiji' Huoxiang zhengqi Oral liquid in the treatment of gastrointestinal type cold: randomized, double-blind, placebo parallel control, multicenter clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800014834
Enrollment
Unknown
Registered
2018-02-07
Start date
2017-12-25
Completion date
Unknown
Last updated
2018-03-12

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

Conditions

gastrointestinal type cold

Interventions

high dose group (Waigan fenghan neishang shizhi):Huoxiang zhengqi oral liquid
low-dose group (Waigan fenghan neishang shizhi):Huoxiang zhengqi oral liquid + agglutinate oral liquid
placebo group (Waigan fenghan neishang shizhi):Huoxiang zhengqi oral liquid vehicle
high dose group (Shushi):Huoxiang zhengqi oral liquid
low-dose group (Shushi):Huoxiang zhengqi oral liquid + agglutinate oral liquid
placebo group (Shushi):Huoxiang zhengqi oral liquid vehicle

Sponsors

Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. signed informed consent; 2. conforming to the diagnostic of gastrointestinal type cold; 3. meet the symptom (Waigan fenghan neishang shizhi or Shushi )of TCM standards 4. within 48 hours after the onset of gastrointestinal type cold; 5. between the ages of 18 to 65 years old.

Exclusion criteria

Exclusion criteria: 1. body temperature > 38.5 degree C; 2. blood leukocyte 10.0*10^9/L and/or neutrophils (N) classified > 80%; 3. due to the patients with severe diarrhoea or high fever lead to dehydration, electrolyte imbalance to intravenous supplement electrolyte or water, or due to gastrointestinal discomfort or vomiting cannot eat, need by intravenous fluids to maintain the body's basal metabolism; 4. influenza, acute viral or herpetic pharyngitis and laryngitis, acute pharyngeal conjunctivitis, acute bacterial sinusitis, acute pharyngeal tonsillitis, allergic rhinitis; 5. combined bronchitis, chronic bronchitis, pneumonia, bronchiectasis and other acute lower respiratory diseases; 6. gastrointestinal symptoms caused by food poisoning, overeating, or inflammation of other organs; 7. combined with bacterial dysentery, infectious, allergic enteritis, functional dyspepsia, irritable bowel syndrome and other gastrointestinal diseases; 8. serious heart, liver, kidney, blood system, endocrine system, and other primary diseases, tumor or AIDS; 9. ALT, AST > 1.5 times normal reference value limit; Abnormal blood creatinine; Urinary protein > +; Routine stool examination showed BBB 0 1/HP and/or pus cells and/or phagocytes; Positive fecal occult blood test; 10. other drugs that have been used to treat the disease after the onset of illness; 11. pregnancy or preparation of pregnant women, lactating women; 12. allergic constitution or allergy to this drug or alcohol; 13. to participate in other drug clinical trials within 3 months; 14. the researcher considers it inappropriate to participate in this study.

Design outcomes

Primary

MeasureTime frame
Disease recovery time;

Secondary

MeasureTime frame
Total symptom score of gastrointestinal type cold.;The symptom score of gastrointestinal symptoms by AUC.;TCM score;Single symptom of TCM (disappearance rate);recovery rate;

Countries

China

Contacts

Public ContactShengsheng Zhang

Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University

zhss2000@163.com+86 010-52176634

Outcome results

None listed

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