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A clinical trial for efficacy and safety of an integrated traditional chinese medicine intervention based on herbal formula Qinghua in the management of obese patients with hyperglycemia

Efficacy and safety for an integrated traditional chinese medicine intervention based on herbal formula Qinghua and syndrome element differentiation in the management of obese patients with hyperglycemia: a randomized, placebo-controlled clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800019287
Enrollment
Unknown
Registered
2018-11-03
Start date
2018-11-08
Completion date
Unknown
Last updated
2018-11-05

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

Conditions

Obesity

Interventions

Experimental group:integrated traditional chinese medicine intervention based on herbal formula Qinghua and syndrome element differentiation
Control group:intervention based on herbal placebo and syndrome element differentiation

Sponsors

Shuguang Hospital afiliated with Shanghai University of TCM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) patients in accordance with the criteria of the obesity and diabetes; 2) charactered with SHI RE YUN PI Syndrome; 3) Aged 18 to 65 years; 4) with stable anti-diabetic theraphy at least 2 months, HbAlc 7% to 9%; 5) undergoing lifestyle intervention with body weight loss less than 2kg in last three months; 6) signing of the informed consent.

Exclusion criteria

Exclusion criteria: 1) secondary obesity; 2) women in pregnancy and lactation; 3) severe primary diseases such as severe digestive system disease, heart and brain blood vessel, liver kidney and other serious diseases; 4) in accordance with syndrome element Yang; 5) using adrenal cortex hormone, beta blocker; 6) weight reduction surgery was accepted in one year; 7) refusing to adjust diet and exercise habits under guidance; 8) allergic constitution; 9) adjust anti-diabetic drugs in last two months; 10) severe infection / ketosis occurred within the past three months; 11) elevated ALT more than 1.5 times; 12) elevated Scr; 13) taking GLP-1 receptor agonist.

Design outcomes

Primary

MeasureTime frame
change of body weight;change of body fat mass;TCM syndrome score;change of hemoglobinA1c;Incidence of adverse events;change o waist circumstance;

Secondary

MeasureTime frame
change of body mass index;change of body fat mass index;HbA1c below 7%;change of trunk fat mass;change of fasting plasma glucose;HOMA2-IR;

Countries

China

Contacts

Public ContactTAO Feng

Shuguang Hospital afiliated with Shanghai University of TCM

feng.tao@shsgyy-endo.cn+86 13818808324

Outcome results

None listed

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