Efficacy and safety of a Chinese herbal medicine formula in the management of simple obesity: Randomised placebo-controlled clinical trial

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000255482

Enrollment

Registered

2007-05-11

Start date

2007-06-01

Completion date

2008-11-30

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

Trial will involve 80 obese subjects with BMI above 30. It will be randomised placebo controlled trial. Subjects will take Chinese herbal capsules for 12 weeks. The endpoints will be evaluated every 2 weeks.

Interventions

Randomised Double-blind Placebo-controlled trial Each 500 mg capsule of Chinese herbal formula granule will contain Camellia sinenis (40%), Cassia obtusifolia (40%) , Sophora Japonica (20%).

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Diagnosis

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Healthy volunteers

Inclusion criteria

•Subjects have BMI greater than 30 kg/m2;•Not involved in other clinical trials for the treatment of obesity; •Agree to avail themselves for the period of the study; and •Provide written consent for participation.

Exclusion criteria

Subjects with one or more of the following conditions will be excluded from study:•Loosing more than 5kg in the past 3 months;•Endocrine disorders other than type 2 diabetes mellitus; •Uncontrolled hypertension; •Autoimmune or cardiovascular diseases or carrying pace-maker; •Lactating or pregnant women; •Those using drugs affecting the central nervous system or lipid lowering drugs;•Obesity known caused by pharmacotherapy;•Therapy for weight control in the last 6 months;•Kidney or hepatic disease;•Unable to read or understand English.

Outcome results