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Methodological study on quality evaluation of compound Chinese medicine related to clinical efficacy

Methodological study on quality evaluation of compound Chinese medicine related to clinical efficacy

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074849
Enrollment
Unknown
Registered
2023-08-17
Start date
2023-08-17
Completion date
Unknown
Last updated
2023-08-21

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

Conditions

pre-diabetes or type 2 diabetes

Interventions

pre-diabetes or T2DM:Jinqi Jiangtang Tablets (a drug approved by the state for marketing), oral, taken half an hour before meals, 2 tablets at a time, 3 times a day, 2 months a course of treatment

Sponsors

Beijing Friendship Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Conform to the diagnostic criteria of pre diabetes or type 2 diabetes; 2) Men and women aged = 18 years and = 75 years; 3) Willing to participate in and sign the informed consent form, able to understand and willing to comply with the requirements of the research program to complete the study.

Exclusion criteria

Exclusion criteria: 1) Complicated with serious primary diseases such as heart, cerebrovascular, liver, kidney and hematopoietic system; 2) Severe complications of diabetes; 3) Women who are pregnant or preparing for pregnancy and lactating women; 4) Psychosis, lack of insight or inability to express intention accurately; Or not in accordance with the author (those who do not cooperate with the diet or do not use drugs as required); 5) Those who have participated in other clinical researches within 4 weeks; 6) Patients who have received medical treatment for diabetes; 7) Allergic constitution; 8) Poor compliance; 9) Any other situation that the researcher thinks is not suitable for participating in this study.

Design outcomes

Primary

MeasureTime frame
HbA1c;FPG;2h PG;

Secondary

MeasureTime frame
Total effective rate;INS;HOMA-IR;BMI;intestinal flora;Metabolomics of plasma;Plasma proteome;Serum lipid;Overall incidence of adverse events and individual incidence of adverse events;The laboratory checks for changes in parameters;

Countries

China

Contacts

Public ContactYan Dan

Beijing Friendship Hospital, Capital Medical University

yd277@126.com+86 134 8867 8873

Outcome results

None listed

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