Skip to content

Clinical research on Post-marketing Jinlida granule Assessment

The combined Jinlida granule and metformin treatment in patients with type 2 diabetes mellitus:A randomized, parallel-group, multicenter, double-blind and prospective study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13003159
Enrollment
Unknown
Registered
2013-03-15
Start date
2013-03-20
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Diabetes Mellitus

Interventions

treatment group:metformin +Jinlida granule 1bag, 3 times / day, warm boiling water
matched group:metformin

Sponsors

Guang'anmen Hospital, China Academy of Chinese medical sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. According to WHO diagnostic criteria of type 2 diabetes; 2. Into the group through the specification of diet control +exercise therapy + Stable doses of metformin for more than 3 months; 3. On an empty stomach blood sugar 7.0-13.9mmol/L, or after having meal two hours >=11.1mmol/L; 4. Glycated hemoglobin >=7.0%; 5. BMI 18 to 40 kg/m2; 6. Ages ranged from 4 to 14 years old; 7. They signed the consent form.

Exclusion criteria

Exclusion criteria: 1. Type 1 diabetes mellitus,Gestation diabetes mellitus and other special type ones; 2. In the past 3 months taking weight loss drugs, (including diet pills), oral any diabetes medication or insulin resistance in addition to the metformin outside; 3. With severe gastrointestinal disease, or be suffering from severe gastrointestinal diseases, such as: gastrointestinal ulcers, gastrointestinal bleeding, gastroparesis, pyloric stenosis, such as gastric bypass surgery; 4. Nearly one month have diabetes ketosis, ketosis acidosis ketosis high permeability diabetic coma, stress situation such as severe infection, operation; 5. With severe liver, renal insufficiency, Serum Creatinine (Cr)>132.6umol/L (1.5mg/dL); 6. Patients with clinically uncontrolled hypertension. (Blood pressure >=160/100mmHg); 7. TG >5.65mmol/L; 8. Diabetic complication as the main symptom; 9. Psychopath, alcoholism and/or psychoactive substances, substance abuser and dependent; 10. pregnancy or lactation woman; 11. Allergic constitution.

Design outcomes

Primary

MeasureTime frame
glycosylated hemoglobin;

Countries

China

Contacts

Public ContactTong Xiaolin
lfm565@sohu.com+86 010 88001402

Outcome results

None listed

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