Table 1.
Summary of included clinical studies
| Authors[ref]; Year of Publication; Country |
Study Design; Duration; Jadad Score |
Study population | Sample Size (I / C); gender; Age |
CFE formulation and dose; Placebo |
Parameter(s) Studied | Significant Outcomes | Adverse side effects | |||
|---|---|---|---|---|---|---|---|---|---|---|
| Obesity (Ob) Metabolic (M) | Appetite | Obesity/ Metabolic |
Appetite | |||||||
|
Arora et al. [19]; 2015; India |
R, PC; 12 weeks; 4 points |
Overweight or obese BMI > 25 kg/m2 |
89 (47 / 42); Both genders; 18–50 years |
CFE capsule 0.5 g/bd; Placebo |
Ob M |
BW, BMI, WC, HC, WHR, TC, HDL, LDL, HDL: LDL, VLDL, FBS, PPS, ALS, ALT, ALP, RFT, CBC, BP, HR, ECG |
VAS appetite assessment: hunger, thoughts of food, urge to eat, fullness of stomach | NS | NS | Nausea (8.5%), Palpitation, Glossitis, Insomnia (4.2%), Generalized weakness (10.6%), Constipation, Exacerbation of blood pressure (2.1%) |
|
Astell et al. [5]; 2013; Australia |
R, DB, PC; 12 weeks; 5 points |
Overweight or centrally obese BMI > 25 kg/m2 or WC > 94 cm (male), > 80 cm (female) |
33 (17 / 16); Both genders; 29–59 years |
CFE capsule 0.5 g/bd; Placebo |
Ob M |
BW, BMI, WC, HC, WHR, SBP, DBP, HR, FBS, TAG, TC, HDL, LDL, HDL: LDL, Leptin |
Energy and nutrient intake, VAS appetite assessment: hunger, desire to eat, fullness of stomach | WC, WHR |
Palatability (visual appeal, smell, taste) sodium intake |
Mild rash and constipation earlier on and then subsided |
|
Cabrera-Rode [20]; 2017; Cuba |
OL; 3 months; 1 point |
Overweight and obese with/without IFG BMI = 25–44 kg/m2 |
40 (20 IFG, 20 non-IFG); Both genders; 23–60 years |
Obex powder sachet [1.5 g CFE] bd, before main meal |
Ob M |
BW, BMI, WC, HC, WHR, WhtR, SBP, DBP, FBG, FI, HbA1c, TC, TAG, HDL, Creatinine, UA, ALT, AST, GGT, Hb, Serum Iron, HOMA-β, HOMA-IR, QUICKI, Bennett, Raynaud |
NR | WT, BMI, WC, WHR, WHtR, HC (+IFG), BP (−IFG), FBS (+IFG), IF (+IFG), HDL, HOMA-β(+IFG), HOMA-IR (+IFG), QUICKI(+IFG), Bennett (+IFG), Raynaud (+IFG) | NR | Rashes, headache, diarrhoea, nausea, dyspepsia and bloating were recorded |
|
Griggs et al. [16]; 2015; Australia |
R, DB, PC, CO; 4 weeks; 4 points |
Prader-willi Syndrome, NG |
15; Both genders; 9.27 ± 3.16 years |
CFE capsule 1.0–0.5 g (250 mg / 10 kg BW); Placebo |
Ob | BW | Hyperphagia questionnaire | NR | Hyperphagia | NR |
|
Kell et al. [17]; 2019; Australia |
R, DB, PC; 8 weeks; 5 points |
Healthy –overweight BMI < 30 |
97 (49 / 48); Both genders; 18–70 years |
CFE capsule 0.5 g/bd; Placebo |
Ob | BW, BMI | NS | NG | NG | |
|
Kuriyan et al. [10]; 2007; India |
R, DB, PC; 60 days; 5 points |
Overweight or obese BMI > 25 kg/m2 |
50 (25 / 25); Both genders; 25–60 years |
CFE capsule 1 g/day; Placebo |
Ob M |
BW, BMI, WC, HC, fat% FBS, PPS, TC, HDL, LDL, TAG |
Energy and nutrient intake, VAS appetite assessment: hunger, thoughts of food, urge to eat, fullness of stomach | WC | Hunger (%) | abdominal distention, flatulence, constipation and gastritis (24%) |
|
Laura et al. [15]; 2015; Spain |
R, DB; 2 months; 1 point |
Overweight or obese BMI > 25 kg/m2 |
44; Woman; 35–62 years |
Obex powder sachet [1.5 g CFE] bd, before lunch and dinner |
Ob M |
BW, Bicipital fold, Triceps fold, Subscapular fold, suprailiac fold, %fat, Total muscle mass, arm muscle mass, leg muscle mass, trunk muscle mass, body water%, SBP, DBP, FBS, TC |
NG | Bicipital fold, Triceps fold, Subscapular fold, suprailiac fold, trunk muscle mass, % | NG | NG |
ALS Amyotrophic lateral sclerosis; ALT Alanine transaminase; ALP Alkaline phosphate; AST Aspartate Aminotransferase; B Biochemical; BMI Body mass index; BW Body weight; BP Blood pressure; CBC Complete blood count; CFE Caralluma Fimbriata Extract; CO Crossover; DB Double blind; DBP Diastolic blood pressure; ECG Electrocardiography; F1 Fibrosis; FBG Fasting blood glucose; GGT Gamma glutamyl transferase; Hb Haemoglobin; HbA1C Glycated haemoglobin; HC Hip circumference; HDL High density lipoprotein; HOMA IR – Homeostatic model assessment – Insulin resistance; HOMA – β Homeostatic model assessment – Beta cell function; HR Heart rate; IFG Impaired fasting glucose; LDL Low density lipoprotein; M Metabolic; NR Not reported; NG Not given; NS Not shown; Ob Obesity; OL Open labeled; PC Placebo controlled; PPS Postprandial sugar; QUICKI Quantitative insulin sensitivity check index; R Randomised; RFT Renal function test; SBP Systolic blood pressure; TC Total cholesterol; TAG Triglycerides; UA Urinalysis; VAS Visual analogue scales; VLDL Very low-density lipoprotein; WC Waist circumference; WHR Waist to hip ratio; WHtR Waist to height ratio