Table 2.
Poly-herbal formula studies in child and adolescent clinical and non-clinical populations.
| Author | Intervention | n | Male (%) | Duration | Population | Safety | Dropouts (%) | Results (ES) |
|---|---|---|---|---|---|---|---|---|
| D’souza & Chavda (1991) | Mentat × 1–2 Tsp p/d (BM: 144–288 mg p/d) PL × 1–2 Tsp p/d |
60 30 (B) 30 (P) |
82 | 3-months | 3–16 yrs Behavioural Problems | Not declared | 0 | YBI- Hyperactivity (ES: 6.55); Tractability (ES: 5.57); Habituation (ES: 5.20); Negative effects (ES: 4.31); Social (ES: 4.88); Academia (ES: 3.52); Impulsivity (ES: 5.10) |
| Patel & Pereira (1991) | Mentat × 2 Tsp p/d (BM: 288 mg p/d) PL x 2 Tsp p/d |
40 20 (B) 20 (P) |
N/A | 3–7-months | 2–7 yrs approx. Hyperkinesis | Nil side effects reported by participants | N/A | YBI-ES: N/A I.Q.-ES: N/A |
| Dave et al. (Study I) (1993) | Mentat × 2 Tsp 3/d (BM: 864 mg p/d) PL × 2 Tsp 3/d |
19 10 (B) 9 (P) |
N/A | 3-months | 1–18 yrs Mental retardation | Not declared | 5 | CBI-ES: 5.77 |
| Quadri (1993) | Mentat × 2–4 Tabs p/d (BM: 272–544 mg p/d) PL × 2–4 Tabs p/d |
50 30 (B) 20 (P) |
70 | 20-months | 4–12 yrs Mental retardation Behavioural issues | Nil side effects reported by participants a | 12 | Behavioural Changes-ES: N/A |
| Kalra et al. (2002) | Mentat × 2 Tabs p/d (BM: 272 mg p/d) PL × 2 Tabs p/d |
60 30 (B) 30 (P) |
78 | 6-months | 6–12 yrs ADHD Diagnosed | Not declared | 17 | CPRS-ES: N/A |
| Upadhyay et al. (2002) | Group N-PL Group P-Mentat Group S/F-PL Group R/G-Mentat (BM: unknown) |
100 25 (P) 25 (B) 25 (P) 25 (B) |
0 | 6-months | 11–16 yrs Learning disability | Not declared b | 5 | Group P-Coding (TES: 1.48); Sequential (TES: 1.77); Full scale I.Q. (TES: 0.94); Arithmetic (TES: 1.41); Digit Span (TES: 1.14). Group R/G-Coding (TES: 1.95); Sequential (TES: 2.45); Full Scale I.Q. (TES: 1.78); Performance I.Q. (TES: 1.40); Arithmetic (TES: 2.39); Digit Span (TES: 1.52). |
| Ojha et al. (2007) | A-MN1 × 200 mg/kg/d B-MN1 × 200 mg/kg/d + Shirodhara c C-PL × 2/d D-PL + Shirodhara (BM: unknown) |
48 d 10 (B) 10 (B) 10 (B) 10 (P) |
80 * | 3-months | 6–15 yrs ADHD Diagnosed | Nil side effects were reported by participants | 17 | ADHD Sx—ES: N/A CDA (TES: A—1.96; B—4.49; D—1.38) RT (TES: A—3.73; B—6.74; D—4.24). |
| Katz et al. (2010) | CHP × 3 mL 3/d PL × 3 mL 3/d (BM: unknown) |
120 80 (B) 40 (P) |
77 * | 4-months | 6–12 yrs ADHD Diagnosed | Safety well monitored. Few adverse events were reported e | 18 | TOVA: Response time (ES: 0.70) Variability (ES: 1.02) Overall (ES: 1.11). |
| Dutta et al. (2012) | Memomet × 1 Tsp 2/d (BM: 250 mg p/d) PL × 1 Tblsp 2/d |
86 56 (B) 30 (P) |
86 | 4-months | 6–12 yrs ADHD Diagnosed | Nil side effects were reported by participants | 15 | MISIC (ES: 0.90) CPRS (ES: 0.86) YBI (ES: N/A) |
BM—B.monnieri; PL—placebo; MN1—Manas Niyamak Yoga Granule; CHP—Compound Herbal Preparation; mg—milligrams; mL—millilitres; mL/kg—millilitres per kilogram; Tsp—teaspoon; Tab—Tablet; Tabs—Tablets; p/d—per day; 2/d—twice a day; 3/d—three times a day; 4/d—four times a day; (B)—B.monnieri; (P)—placebo; N/A—not available. yrs—years; ADHD—Attention-Deficit/Hyperactivity Disorder; CPRS—Conners’ Parent Rating scale; I.Q. —intelligence quotient; MISIC—Malin’s Intelligence Scale for Indian Children; ES—Effect Size (Cohen’s d – treatment versus placebo); TES—treatment effect size (Cohen’s d—change from baseline); ES: N/A—Effect size not available; CBI—Children’s Behavioural Inventory; RT—Reaction Time; * Percentage is based on males who completed the study. Sex of dropouts was not reported, so percentage of male participants may be higher. a Four Children dropped out of Mentat group, and two dropped out of placebo group; b authors stated that no child showed any behaviour or speech abnormalities during the trial—it is not clear as to whether they are referring to possible side effects; c Shirodhara Treatment: milk poured over the forehead of the participant from a height of 3.14 inches, oscillating left to right for 30–45 min/day; d forty-eight participants were included in this trial; 8 dropped out. It is unclear which groups these 8 participants were assigned to prior to dropping out of the study; e all adverse effects were reported as “mild, transient and did not persist past the first two weeks of treatment”; there were no differences in reported adverse events between groups; control group suffered greater than 50% withdrawal from study.