Table 4.
In vitro and in vivo pharmacological studies and the study design evaluation.
| Herbal Drug and Subjects | Assay/Parameters | Outcome of Treated Group | Study Design Evaluation | Reference |
|---|---|---|---|---|
| In Vitro Studies | ||||
| TT fruit extract | α-Glucosidase | Activity inhibition on all tested enzymes | Part of the plant: YES | Lamba et al. (2011) |
| Aldose reductase | Origin: YES | [99] | ||
| Phytochemical analysis: NCS | ||||
| Control group: YES | ||||
| Positive control group: YES | ||||
| Appropriate statistical analysis: YES | ||||
| TT seeds | α-Amylase | Concentration- inhibition of enzyme activity | Part of the plant: YES | Ponnusamy et al. (2011) |
| Kinetic studies. | Origin: YES | [96] | ||
| Phytochemical analysis: YES (identification reactions, GC/MS) | ||||
| Positive control: YES | ||||
| Appropriate statistical analysis: YES | ||||
| TT leaves | Lipase | Activity inhibition on all tested enzymes | Part of the plant: YES | Ercan and El (2016) |
| α-Amylase | Origin: YES | [95] | ||
| α-Glucosidase | Phytochemical analysis: YES (spectrophotometric) | |||
| Positive control: YES | ||||
| Appropriate statistical analysis: YES | ||||
| In Vivo Animal Studies | ||||
| Male Swiss albino rats with STZ-induced diabetes (55 mg/kg) | BW, BG, Hb, HbA1c, TG, TC, HDL, LDL-c | BW ↑* | Part of the plant: YES | El-Tantawy and Hassanin (2007) |
| TT aerial part extract | Histopathological analysis of the pancreas | BG ↓* after 2,4, and 6 h | Origin: YES | [98] |
| HbA1c returned to the normal values | Phytochemical analysis: NO | |||
| HDL ↑* | Control group: YES | |||
| TG, TC, LDL-c ↓* | Positive control group: YES | |||
| Histological structure was less affected as compared with the control group | Appropriate statistical analysis: YES | |||
| Wistar rats with STZ-induced diabetes (50 mg/kg) | BG, BW, HbA1c, INS, GLG | BG ↓* | Part of the plant: YES | Lamba et al. (2011) |
| TT fruit extract | Urinary albumin levels | BW ↑* | Origin: YES | [99] |
| HbA1c, GLG ↑ | Phytochemical analysis: NCS | |||
| Control group: YES | ||||
| Positive control group: YES | ||||
| Appropriate statistical analysis: YES | ||||
| Male Wistar rats with STZ-induced diabetes (40 mg/kg) | BG | BG, PT, APTT, TC, TG, LDL, ALT, AST, ALP, glucose-6-phosphatas, fructose-1, 6-bisphosphatase, LPO ↓ * | Control group: YES | Kalailingam et al (2014) |
| Diosgenin | HbA1c | HDL, SOD, CAT, GSH ↑ * | Positive control group: NO | [101] |
| TC, TG, HDL, LDL, AST, ALP | Appropriate statistical analysis: YES | |||
| PT, APTT | ||||
| Hepatic glucose-6-phosphatase, fructose-1, 6-bisphosphatase SOD, CAT, GSH, LPO | ||||
| Male Sprague Dawley rats with type 2 diabetes induced with high-fat diet (HFD) + STZ (35 mg/kg) | BG, INS, BW | BG ↓ *, INS ↑ *, BW ↑ * | Control group: YES | Tharaheswari et al. (2014) |
| Diosgenin | FFA, TNF-α, IL-6, leptin | FFA, TNF-α, IL-6, leptin ↓ * | Positive control group: NO | [102] |
| HOMA-IR, HOMA-B, QUICKI | HOMA-IR, HOMA-B, QUICKI – improved values | Appropriate statistical analysis: YES | ||
| In tissue homogenate were determined: LPO, GSH, SOD, CAT, GPx | Increased adipose tissue mass | |||
| Histopathological analysis of pancreas | Enhanced PPARc expression | |||
| Quantification of adipose PPAR γ | Good interaction of diosgenin with PPAR γ | |||
| Glucose-loaded normal rabbits, | FBG at 30 min, 1, 2, 3 h after dosing | FBG ↓* at 2 hours | Part of the plant: YES | El-Shaibany et al. (2015) |
| TT aerial parts extract | Acute toxicity study | No toxicity | Origin: YES | [100] |
| Phytochemical analysis: YES (TLC) | ||||
| Control group: YES | ||||
| Positive control group: YES | ||||
| Appropriate Statistical analysis: YES | ||||
| Male Wistar rats with STZ-induced diabetes (55 mg/kg) | BG | BG ↓* | Part of the plant: YES | Tag et al. (2015) |
| TT fruit extract | INS | INS ↑* | Origin: YES | [85] |
| Phytochemical analysis: YES (identification reactions) | ||||
| Control group: YES | ||||
| Positiv control group: YES | ||||
| Appropriate Statistical analysis: YES | ||||
| Sprague Dawley rats with type 2 diabetes induced with high-fat and high-sugar feeding and STZ (30 mg/kg) | BG | BG ↓ | Part of the plant: NO | Zhang et al. (2019) |
| Gross saponins of TT | BW | No significant differences in BW | Origin: YES | [86] |
| Phytochemical analysis: NCS | ||||
| Control group: YES | ||||
| Positive control group: YES | ||||
| Appropriate statistical analysis: YES | ||||
| Clinical Studies | ||||
| 100 Patients suffering from DM with microalbuminuria | BG | BG ↓ * | Part of the plant: NCS | Ramteke et al. (2012) |
| Ayurvedic preparation with TT | BP | BP ↓ * | Origin: NCS | [105] |
| Urine albumin | Urine albumin ↓* | Phtochemical analysis or standardization: NO | ||
| Placebo group: NO | ||||
| Randomization: YES | ||||
| Double-blind: NCS | ||||
| Appropriate statistical analysis: YES | ||||
| Double-blind randomized placebo controlled clinical trial | FBG, BG 2-hour postprandial HbA1c | BG ↓* | Part of the plant: NCS | Samani et al. (2016)[104] |
| Ninety-eight women with diabetes mellitus type 2 | TG, TC, LDL, HDL | TC, LDL ↓* | Origin: YES | |
| TT extract | HbA1c, TG, HDL - no significant differences as compared with the placebo | Phtochemical analysis or standardization: YES | ||
| Placebo group: YES | ||||
| Randomization: YES | ||||
| Double-blind: YES | ||||
| Appropriate statistical analysis: YES | ||||
NCS, not clearly specified; GC/MS, gas chromatography-mass spectrometry; TLC, thin layer chromatography; STZ, streptozotocin; BW, bodyweight; BG, blood glucose; Hb, hemoglobin; HbA1c, glycosylated hemoglobin; TG, serum triglycerides; TC, total cholesterol; HDL, high density lipoprotein; LDL-c, low density lipoprotein cholesterol; INS, insulin; GLG, glycogen; FBG, fasting blood glucose; AST, aspartate aminotransferase; ALP, alkaline phosphatase; PT, prothrombin time; APTT, activated partial thromboplastin time; SOD, superoxide dismutase; CAT, catalase; GSH, glutathione; LPO, lipid peroxidase; FFA, serum free fatty acids; TNF-α, tumor necrosis factor-α; IL-6, interleukin-6; HOMA-IR, homeostasis model assessment of insulin resistance; HOMA-B, homeostasis model assessment of β-cell function; QUICKI, quantitative insulin sensitivity check index, PPARγ, peroxisome proliferator-activated receptor gamma; GPx, glutathione peroxidase; BP, blood pressure; *, significant difference as compared with the control group and the placebo group.