CLINICAL STUDY ON THE ROLE OF AN AYURVEDIC COMPOUND (MANAS NIYAMAK YOGA) AND SHIRODHARA

CLINICAL STUDY ON THE ROLE OF AN AYURVEDIC COMPOUND (MANAS NIYAMAK YOGA) AND SHIRODHARA

IN THE MANAGEMENT OF ADHD IN CHILDREN

Prof. Dr. ABHIMANYU KUMAR M Sc (Psy) MD (Ayurveda), DCA, D.Yoga, PhD (Ayurveda)

DIRECTORALL INDIA INSTITUTE OF AYURVEDA

New Delhi (India)&

Director GeneralCENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES

e mail : ak_ayu@yahoo.co.in

DEFINITIONDEFINITION

• ADHD is characterized by inattention, including increased distractibility and difficulty sustaining attention, poor impulse control and decreased self inhibitory capacity, and motor over activity and motor restlessness –

DSM-IV (American Psychiatric Association, 1994)

PREVALENCEPREVALENCE

– According to the 2000 edition of DSM-IV- TR, ADHD affects 3-7% of all children in the U.S.

(APA, 2000)

– The prevalence of ADHD in the general population of school age children is about 3-5% in the west.

(Anderson JC, et al., 1987;Swanson JM et al., 1998)

Male To Female Ratio Male To Female Ratio

– ADHD is 4-6 times more common in boys than in girls. (Bhatis MS et. al., 1991)

– Ratio varies between 2:1 and 4:1. (Wolraich ML et. al., 1989)

– Male to female ratio ranges from 4:1 to 9:1 (DSM – IV; Szatmari P et. al., 1989)

– Male to female ratio was 6.4:1.

(Maya Mukhopadhyaya et al.,2003)

AIM & OBJECTS OF THE STUDYAIM & OBJECTS OF THE STUDY

To enhance mental performance. To get answer of the problem without any

side effects. To provide relief in symptoms of ADHD. To improve school performance and to

improve overall health status of child.

MATERIAL AND METHODSMATERIAL AND METHODS

A randomized double blind placebo control study was conducted in children with ADHD.

SELECTION OF CASES• Source - Children for the present study were screened

out from OPD of National Institute of Ayurveda, Jaipur and from various schools, situated in Jaipur by survey method.

• Age group - Children between 6 to 15 years were considered for study.

• Numbers of cases- 48 children were registered out of which 8 children discontinued the treatment.

GROUPING OF PATIENTSGROUPING OF PATIENTSSelected children were randomly divided into four groups keeping in mind that

all the four groups had children from various grades (classes), schools & socio economic strata.

• Group A – This group of 10 children were given the Ayurvedic compound Manas Niyamak Yoga (MN1 granules).

• Group B – This group of 10 children were given the Ayurvedic compound (MN1 granules) + shirodhara(ksheerdhara)

• Group C – This group of 10 children were given only placebo.

• Group D – This group of 10 children were given placebo (MN2 granules) + shirodhara.

DIAGNOSTIC CRITERIADIAGNOSTIC CRITERIA

Pre-assessment screening of ADHD children was done according to ADHD pre-assessment criteria based on DSM - IV criteria.

Inclusion Criteria • Subjects aged 6-15 yrs of either sex

satisfying DSM- IV criteria. • Children with average / normal IQ level.

Exclusion CriteriaExclusion Criteria

• Children with physical disability.

• Children with psychiatric illness.

• Children with gross brain damage causing mental retardation.

• Children with any genetic disorder

• Unreliable history.

Discontinuation criteriaDiscontinuation criteria

• Any acute or severe illness.

• Parents not willing to continue the treatment

Assessment criteriaAssessment criteria

• DSM – IV

• Coefficient of Division of Attention

• Reaction Time

• Finger Dexterity Test

• IQ assessment

Side effect evaluation criteria Side effect evaluation criteria

To rule out possible side effects of the study drugs, clinical criteria were adopted. It included the documentation of information related to change in appetite, sleep, abdominal features, drowsiness, irritability etc.

MaterialMaterial For diagnosis of ADHDFor diagnosis of ADHD

• A pre-assessment questionnaire was made on the basis of DSM- IV criteria having 18 questions, which were filled up, by the schoolteachers and parents of the patients.

• DSM – IV -TR Criteria • Division of Attention Board (Electrical) -for Attention

Span• Vernier Chronoscope (electronic)-for assessment of

Reaction Time.• Finger Dexterity Board with pins- for assessment of

Motor Ability. • ‘Draw – A- Man’ test for Indian children for assessing

the IQ of the child.

DRUGDRUG (MANAS NIYAMAK YOGA) (MANAS NIYAMAK YOGA)

Contents of Study Drug• Brahmi (Bacopa monnieri)1 Part• Mandukparni (Centella asiatica)1Part• Shankhpushpi (Convolvulous pluricaulis)1Part• Jatamansi (Nardostachys jatamansi) 1Part• Vacha (Acorus calamus)1Part• Ashwagandha (Withania somnifera) 1Part• Vidanga (Embelia ribes) 1Part• Madhuyasti (Glycyrrhiza glabra)1Part• Chitraka (Plumbago zeylanica) 1Part• Pippali (Piper longum)¼ Part

BRAHMI (Bacopa Monnieri)

MANDUKAPARNI (Centella asiatica)

SHANKHPUSHPI (Convolvulous pluricaulis)

JATAMANSI (Nardostachys jatamansi)

VACHA (Acorus calamus)

ASHWAGANDHA (Withania somnifera)

VIDANGA (Embelia ribs)

MADHUYASHTI (Glycyrrhiza glabra)

CHITRAK (Plumbago zeylanica)

PIPPALI (Piper longum)

SHIRODHARA (KSHEERDHARA)SHIRODHARA (KSHEERDHARA)

In this process, the milk was poured over the forehead of patients in the form of a regular stream from a specific height of about 8 cms in a fixed fashion in the form of oscillatory movements i.e. to & fro movement of milk stream over the forehead of the patients for 30-45 minutes daily for 2 weeks.

PLACEBO PLACEBO

The placebo for the study was also in the form of granules with the same color and texture as study drug (Granules MN2) containing starch and sugar.

CRITERIA OF ASSESSMENTCRITERIA OF ASSESSMENT

After 3 months of treatment, the tests were re-administered. Effect of the therapy was assessed on the basis of improvement in obtained scores in Attention Span, Reaction Time, Motor Ability and DSM-IV criteria. IQ levels were also assessed after 3 months of treatment.

RESULTS

CO-EFFICIENT OF DIVISIION OF ATTENTION (CD)

Showing change in Co-efficient of Division of Attention (CD)

Mean score Groups

BT AT Diff. N % SD SE (±)

‘t’

Value

‘p’

Value

Group A 0.35 0.29 0.06 10 17.14 0.0306 0.0097 05.773 <0.001

Group B 0.34 0.27 0.07 10 20.58 0.0156 0.0049 14.2857 <0.001

Group C 0.33 0.32 0.005 10 01.52 0.0139 0.0044 01.1363 >0.10

Group D 0.34 0.32 0.02 10 05.88 0.0145 0.0046 04.130 <0.01

•Statistically highly significant change in coefficient of division of attention was observed group A and B

(P<0.001)

•Significant change was observed in-group D (p<0.01)

17.14

20.58

1.52

5.88

0

5

10

15

20

25

%

Group A Group B Group C Group D

Change in Coefficient of Division of Attention

Groups

Table Showing change in Reaction Time

Mean score Groups

BT AT Diff. N % SD SE (±)

‘t’

Value

‘p’

Value

Group A 01.36 0.72 0.64 10 47.42 0.1715 0.0542 11.8753 <0.001

Group B 01.20 0.53 0.67 10 55.83 0.0994 0.0314 21.3375 <0.001

Group C 01.36 01.41 -0.51 10 03.75 0.0610 0.0193 02.642 >0.10

Group D 01.29 0.91 0.38 10 29.07 0.0897 0.0284 13.2394 <0.001

•Groups A, B and D showed statistically highly significant change in Reaction Time (P<0.001).

•Group B showed maximum change (55.83%).

47.4255.83

-3.75

29.07

-10

0

10

20

30

40

50

60

%

Group A Group B Group C Group D

Change in Reaction Time (RT)

GROUPS

Mean score Groups

BT AT Diff.

N % SD SE (±) ‘t’ Value ‘p’

Value

Group A 06.77 06.03 0.74 10

10.96 0.1225 0.0387 19.1730 <0.001

Group B 06.84 05.40 1.44 10

20.98 0.1259 0.0398 36.0552 <0.001

Group C 06.84 06.80 0.04 10

0.61 0.0816 0.0258 01.6280 >0.10

Group D 06.62 06.51 0.12 10

01.85 0.1212 0.0383 03.2110 <0.02

Table Showing change in time taken in Finger Dexterity Test (FDT)

•Statistically highly significant change was observed in group A and B (P<0.001).

•Group D showed statistically significant change (P<0.02).

10.96

20.98

0.61 1.85

0

5

10

15

20

25

%

Group A Group B Group C Group D

Change in Time taken in Finger Dexterity Test (FDT) Right Hand

Groups

24

30.67

22.33

34

40.6740

6.67

4.33

12

29.3427.34

17.67

0

10

20

30

40

50

%

Group A Group B Group C Group D

Overall Improvement in Core Symptoms of ADHD

Inattention Hyperactivity Impulsivity

DISCUSSION

Maximum numbers of ADHD children (47.50%) were between age ranges 6-9 years followed by 37.50% in age group 9-12 years. The data suggest higher prevalence of disease in elementary school years and gradual attenuation of symptoms with the advancement of age.

Children from joint families were more affected (55%).

Study included maximum number of cases (70%) with vata-pitta prakriti . The

symptoms of ADHD are comparable to that of mentioned in individuals with

vata and pitta prakriti. Behaviors of predominantly vata prakriti individuals are more similar to that of ADHD.

Predominance of pitta prakriti over vata is comparable to the co morbidities & associated problems with ADHD like ODD,

Anti-social behavior, violence, aggression, temper tantrums etc.

Maximum number of patients (50%) were of Rajasika-Sattvika prakriti and 30% of patients were of Rajasika-Tamas prakriti. Predominance of rajas part thus may cause

wide emotional swings, low tolerance to emotional changes and exaggerated emotional

reactions that may manifest as ADHD.

Maximum number of cases (70%) had average or poor (20%) parent child relationship. Studies indicate that persistent cases of ADHD seem especially likely to occur where parent child conflict, greater maternal directive ness and negativity, and greater child defiant behavior exist.

Study included Majority of cases (55%) having fewer friends. Children with

ADHD have immature interactive skills, egocentric selfish behavior, low

frustration tolerance, increased sensitivity to environmental stimuli. All of these may lead to rejection by the peer group.

Maximum number of patients (22.50%) showed a positive family history of

ADHD- alike symptoms. The findings suggest the genetic predisposition and heritability of the disorder.

Academic underperformance was found in most of the ADHD children (85%). It can be concluded that the academic performance

is the most commonly affected areas of child’s functioning in the school years having

ADHD.

65% of cases had aggression and 57.50% had violence associated with ADHD. Anxiety found in 20% of cases. 15% cases presented antisocial behaviors. Self-neglect was found in 30% of cases whereas 25% of cases had limited social skill. Data indicate the presence of co morbid conditions and other associated problems with ADHD.

EFFECT ON CORE SYMPTOMS OF DSM-IV

•Group B showed maximum % of improvement among all the four groups in all the core symptoms while group C showed minimum improvement.

•Group B showed significant gain over group A and group D indicating synergistic effect of study drug and shirodhara.

EFFECT ON REACTION TIME

•Groups A, B and D showed statistically highly significant change in Reaction Time (P<0.001).

•Statistically significant advantage was observed in group B over group A (p<0.01).

•Moderately significant advantage of group A over group D (p<0.02) was observed

EFFECT ON COEFFICIENT OF DIVISION OF ATTENTION SPAN (CD)

•Statistically highly significant change in coefficient of division of attention was observed

group A and B (P<0.001).

•Significant change was observed in-group D (p<0.01).

•Statistical evaluation of differences of change in CD between all the four groups showed insignificant results.

EFFECT ON FDT

•Statistically highly significant improvement in groups A and B (P<0.02), indicating the efficacy of the individuals therapies in each group.

•Only group B showed highly significant advantage over group C (p<0.001) and significant advantage over groups A and D (p<0.02 and p<0.01 respectively), indicating the combined effect of drug and sirodhara in improving the motor ability.

CONCLUSION

Both the study drug & Shirodhara were effective in alleviating the symptoms of ADHD, but drug combined with Shirodhara had much greater potential to ameliorate the symptoms of ADHD rather than the drug or shirodhara alone.

No adverse effects of the drug were observed during the study which indicates the safety profile of the study drug.