Safety and Toxicity
The CDRI (Central Drug Research Institute) Lucknow, conducted the following studies in mice rats, rabbits, and rhesus monkeys.
- acute toxicity
- subacute and chronic toxicity
- teratogenic and mutagenic
The results indicated that Gugulipid® extract was safe for human consumption.
A four-week, phase 1 (safety on chronic administration) study was conducted on 21 subjects with the following conditions.
- 9 patients with Hypertension
- 3 patients with IHD
- 2 patients with Diabetes Mellitus
- 3 patients with Diabetes Mellitus & Hypertension
- 3 patients with IHD & Hypertension
- 1 patient with Gout
All subjects received 400 mg of Gugulipid® three times a day (equivalent to 25 mg of guggulsterones). No adverse effects were reported for liver function, blood glucose, blood urea levels, hematological parameters, or electrocardiogram results. Only one patient complained of epigastric fullness three days after Gugulipid® administration that was controlled by antacids.
