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. 2021 Nov 10;21:279. doi: 10.1186/s12906-021-03450-8

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