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The Biological Basis Research of Qi-deficiency Syndrome based on ZangFu in TCM: A systematic clinical study to explore the biological basis of liver cirrhosis with Qi-deficiency syndrome

The Biological Basis Research of Qi-deficiency Syndrome based on ZangFu in TCM: A systematic clinical study to explore the biological basis of liver cirrhosis with Qi-deficiency syndrome

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800017505
Enrollment
Unknown
Registered
2018-08-02
Start date
2018-08-06
Completion date
Unknown
Last updated
2018-08-20

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

Conditions

liver cirrhosis

Interventions

liver cirrhosis:Qi-tonifying formula
Normal control:none

Sponsors

Xiyuan Hospital of China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 35-70 years old, male or female; 2. TCM diagnosis of Qi-deficiency syndrome or Yang-deficiency syndrome; 3. Meeting the diagnostic criteria of cirrhosis, with or without ascites (Class 1-2); 4. Blood pressure is stabilized below 160/100mmHg, blood glucose is in control, and glycosylated hemoglobin is controlled to below 6.5%; 5. Volunteers participate with signed the Letter of Informed and Consent.

Exclusion criteria

Exclusion criteria: 1. Patients with active gastrointestinal bleeding or spontaneous peritonitis; 2. Those who have complicated accompanying syndromes, including excess syndromes such as phlegm, coldness, and heat toxicity, as well as patients with obvious Yin-deficiency; 3. Patients with severe liver failure; 4. Patients with major systemic diseases combined such as the respiratory system, nervous system, and immune system, patients with malignant tumors or with severe trauma or infection; 5. Patients with allergic constitution; 6. Women who are pregnant, lactating, or have a pregnancy intention or positive pregnancy test (test urine HCG or blood HCG), or those who cannot take effective contraception during the study (effective contraception includes sterilization, IUD, oral contraceptives or the diaphragm method by the local law); 7. Patients who participated in other drug clinical trials in the past 1 month; 8. Patients with mental disorders, neurological impediments, or failure to express themselves or communicate; 9. Alcoholics, drug abusers and addicts.

Design outcomes

Primary

MeasureTime frame
The syndrome scorings of the Qi-deficiency;

Secondary

MeasureTime frame
Ascites regression rate;Albumin content;Liver function;

Countries

China

Contacts

Public ContactPeng Guo

Xiyuan Hospital of China Academy of Chinese Medical Sciences

zhyq992@163.com+86 15810327625

Outcome results

None listed

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