Journal of Ayurveda and Integrated Medical Sciences

2024 Volume 9 Number 12 DECEMBER
Publisherwww.maharshicharaka.in

A clinical study to evaluate the efficacy of Madhuyashti granules and Shirodhara in the management of Attention Deficit Hyperactivity Disorder (ADHD) in school going children

Dharani Z1*, Minakshi2
DOI:10.21760/jaims.9.12.2

1* Zenia Dharani, Post Graduate Scholar, Department of Kaumarbhritya, Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola, Himachal Pradesh, India.

2 Minakshi, Professor, Department of Kaumarbhritya, Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola, Himachal Pradesh, India.

Attention Deficit Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder characterized by inattention, hyperactivity and impulsivity. The growing prevalence of ADHD among school-going children necessitates exploring holistic and integrative treatment approaches. Ayurveda, with its personalized therapeutic interventions, offers a promising avenue for managing ADHD. This clinical study is aimed to evaluate the efficacy of Madhuyashti granules (Glycyrrhiza glabra) and Shirodhara (a classical Ayurvedic therapy) in managing ADHD symptoms in school-going children. A randomized, controlled clinical trial was conducted involving school-going children aged 6-15 years diagnosed with ADHD based on DSM V criteria. Participants were divided into two groups: Group A received Madhuyashti Granules (internally administered) only, while Group B received Madhuyashti Granules (internally administered) alongside Shirodhara therapy. The intervention was administered for 45 days. The primary outcomes were measured using qualitative parent-teacher feedback. Group B exhibited significant improvement in attention span, impulse control and hyperactivity compared to Group A. Madhuyashti Granules, known for their Medhya (nootropic) properties, enhanced cognitive functions, while Shirodhara provided calming effects, reducing hyperactivity and promoting focus. The integrative approach showed no adverse effects, demonstrating safety and efficacy. The combination of Madhuyashti Granules and Shirodhara proved effective in managing ADHD symptoms, offering a natural and holistic alternative for school-going children. Further large-scale studies are recommended to validate these findings and explore long-term benefits.

Keywords: ADHD, Madhuyashti Granules, Shirodhara, Ayurveda, school-going children, neurodevelopmental disorders

Corresponding Author How to Cite this Article To Browse
Zenia Dharani, Post Graduate Scholar, Department of Kaumarbhritya, Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola, Himachal Pradesh, India.
Email:
Dharani Z, Minakshi, A clinical study to evaluate the efficacy of Madhuyashti granules and Shirodhara in the management of Attention Deficit Hyperactivity Disorder (ADHD) in school going children. J Ayu Int Med Sci. 2024;9(12):07-15.
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https://jaims.in/jaims/article/view/4124

Manuscript Received Review Round 1 Review Round 2 Review Round 3 Accepted
2024-11-09 2024-11-19 2024-11-29 2024-12-09 2024-12-21
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© 2024by Dharani Z, Minakshiand Published by Maharshi Charaka Ayurveda Organization. This is an Open Access article licensed under a Creative Commons Attribution 4.0 International License https://creativecommons.org/licenses/by/4.0/ unported [CC BY 4.0].

Download PDFBack To ArticleIntroductionAim and ObjectivesMaterials and MethodsResultsDiscussionConclusionReferences

Introduction

Attention Deficit Hyperactivity Disorder (ADHD) is a psychiatric condition that has long been recognized for its impact on children's ability to function. Individuals with ADHD display developmentally inappropriate levels of inattentiveness, hyperactivity or impulsivity. It is not a newly recognized condition; but has been known by different names throughout history. In the 1930s, it was referred to as "minimal brain dysfunction", and over time, the terminology evolved to ADD and later ADHD[1].

Previously, there were separate diagnoses for Attention Deficit Disorder (ADD) and Attention Deficit Hyperactivity Disorder (ADHD), but the DSM IV combined these into one disorder with three subtypes: predominantly inattentive, predominantly hyperactive and combined type. The prevalence of ADHD has increased, particularly since the 1950s, as schooling became more standardized.

The etiology of ADHD involves a combination of genetic and environmental factors. It is among the most heritable psychiatric disorders. Research indicates that different subtypes have varying prevalence rates within the population.

The inattentive subtype is found in approximately 18.3% of cases, while the hyperactive/impulsive and combined subtypes represent 8.3% and 70% of cases, respectively. Notably, the inattentive subtype is more commonly observed in females. Overall, ADHD has a male-to-female ratio of approximately 2-3:1 according to various studies[2]. It is also estimated to affect around 3-6% of the adult population[3]. It is one of the most prevalent disorders diagnosed during childhood.

The exact correlation of ADHD is not explicitly found in Ayurvedic classics; however, symptoms of abnormal behaviour are scattered throughout these texts. While discussing Nanatmaja Vyadhis (diseases caused by imbalances of specific Doshas), various behavioural abnormalities are mentioned.

Descriptions of aberrant behaviours such as Anavasthita Chittatwam (instability of mind), Mano Vibhrama (perversion of mind), Buddhi Vibhrama (perversion of intellect), Smriti Vibhrama (perversion of memory), Sheela Vibhrama (perversion of manner) and Cheshta Vibhrama (perversion of behaviour) are dispersed throughout the Ayurvedic classics.

These neurobehavioural symptoms are collectively described under Unmada Vyadhi, and they closely resemble the clinical and associated features of ADHD. Hence, it can be considered as Bala Unmada and can be treated accordingly.

ADHD symptoms typically begin at a young age and include difficulties such as lack of attention, poor concentration, disorganization, trouble completing tasks, forgetfulness and frequently losing things. To be diagnosed as ADHD, these symptoms must be present before the age of 7, last for at least six months and significantly interfere with daily life activities. Moreover, these symptoms must be observable in more than one setting (e.g., at home and school, or at school and during after-school activities). It can have significant consequences, including impaired social interactions, increased risky behaviours and academic challenges[4].

ADHD must be understood in the context of what is developmentally and culturally appropriate for an individual. The disorder is primarily considered a dysfunction of executive functioning, predominantly involving the frontal lobe. Consequently, individuals often struggle not only with attention and focus but also with decision-making and emotional regulation. Children with ADHD may face challenges in social interactions, become easily frustrated and act impulsively, leading to them being unfairly labelled as "troublemakers".

Early diagnosis and treatment of ADHD are crucial to prevent persistence of symptoms into adulthood, which can lead to comorbid conditions. Treatment primarily involves stimulant medications and psychotherapy, which help manage symptoms and improve overall quality of life[5].

Recently, an increase in ADHD cases among younger children has been observed, attributed to factors such as heightened awareness, improved diagnostic practices and lifestyle changes.

Increased exposure to digital media and reduced physical activity are particularly believed to exacerbate symptoms such as hyperactivity, impulsivity and inattention. Recognizing ADHD's global impact, the World Health Organization (WHO) identifies it as a significant global health concern, emphasizing the need for ongoing research, timely diagnosis and effective treatment. While modern medicine offers established treatments for ADHD, concerns about side effects,


especially with long-term use, have led to increased interest in safer alternatives like Ayurvedic medicine. Madhuyashti is one of the four best Medhya Rasayana herbs mentioned in classical texts for enhancing cognitive function and mental clarity.

Additionally, Shirodhara, a non-invasive therapy involving the gentle pouring of warm liquids over the forehead, is known for its calming effects and helps alleviate stress and anxiety.

Together, Madhuyashti and Shirodhara provide a safe, natural approach to managing ADHD, addressing its symptoms while enhancing overall mental well-being. In light of this, the present study entitled “A clinical study to evaluate the efficacy of Madhuyashti Granules and Shirodhara in the management of Attention Deficit Hyperactivity Disorder (ADHD) in school going children”, has been undertaken with the following aims and objectives:

Aim and Objectives

1. To study the efficacy of Madhuyashti Granules and Shirodhara in the management of ADHD.
2. To evaluate the clinical safety of Madhuyashti Granules and Shirodhara in children.

Materials and Methods

Selection of patients

Patients of ADHD fulfilling the diagnostic criteria were randomly selected from OPD of Kaumarbhritya and IPD of R.G.G.P.G. Ayurvedic College and Hospital, Paprola, Distt. Kangra (H.P.) irrespective of gender, religion, socio-economic status etc.

Grouping of patients

Enrolled total of 40 study subjects were randomly divided into following two groups:

Group I: 20 Patients in this group were managed with Madhuyashti Granules.

Group II: 20 Patients in this group were managed with Madhuyashti Granules and Shirodhara.

1. Madhuyashti Granules

Route of administration - Oral
Anupana - Milk
Dosage - 80 mg/kg/bid

2. Shirodhara: Ksheera

Shirodhara

Shirodhara is a method of pouring any Drava Dravya like cow’s milk or oil over forehead of patients in the form of a regular stream from a specific height of about 3.14 inches as mentioned in Ayurveda classics in fixed oscillatory movement for 45 minutes per day for at least two weeks.

Duration of the trial: 45 Days

Follow up: At 15th day, 30th day and at the time of completion of study.

Diagnostic Criteria

ADHD affected children were screened by pre-assessment criteria based on DSM V (Diagnostic & Statistical Manual for Mental Disorders).

Inclusion Criteria

  • Individual between age group of 6 to 15 years of both genders having fulfilled DSM V criteria.
  • Parents of patient willing to participate in trial.

Exclusion Criteria

  • Individuals below 6 years and above 15 years of age.
  • Mental disorders like conduct disorder, anxiety, depressive disorders, obsessive disorders and compulsive disorder.
  • Children with schizophrenia.
  • Children having medical illness like hearing loss, hypothyroidism, genetic disorder and seizures.
  • Children having congenital deformity or muscular dystrophy.

Withdrawal Criteria

  • If a child develops any serious condition during the course of clinical trial which requires urgent treatment.
  • If a child’s parent wants to withdraw his/her child from the clinical trial.

Assessment Criteria

1. Objective Criteria

Biochemical Investigations

  • CBC (Hbgm%, TLC, DLC)
  • LFT (SGOT, SGPT)
  • RFT (B. Urea, S. Creatinine)
  • Urine (Routine, Microscopic)

2. Subjective Criteria

To assess the improvement in clinical symptomatology of the patients, a scoring system was adopted based on the DSM V criteria. The scoring ranges from asymptomatic to severe, as detailed below:

Asymptomatic- 0
Mild- 1
Moderate- 2
Severe- 3

SNDSM V Items0123
1.Inattention
a.Fails to give close attention to details or makes careless mistakes in school works or other activities.
b.Difficulty sustaining attention in tasks or play activities.
c.Does not seem to listen to what is being said to him/her.
d.Does not follow through, on instructions and fails to finish school work, chores or duties at the work place.
e.Difficulty in organizing tasks and activities.
f.Avoids, expresses reluctance about or has difficulties in tasks that require sustained mental effort.
g.Uses the things for unnecessary tasks or activities.
2.Hyperactivity
a.Fidgets with hands to feet or squirms in his/her seat.
b.Leaves seats in classroom or in other situations in which remaining seated is expected.
c.Runs about or climbs excessively in situations where it is inappropriate.
d.Has difficulty playing or engaging in leisure activities quietly.
e.Is always ‘on the go’ or acts as if ‘driven by a motor’.
f.Talks excessively.
3.Impulsivity
g.Blurts out answers to questions before the questions have been completed.
h.Has difficulty waiting in lines or in games or group situations.
i.Interrupts or intrudes on others.

Statistical Analysis

Data was statistically analyzed by using appropriate tests. The “Student’s Paired ‘t’ test” was used for individual group and “Unpaired ‘t’ test” was used for intergroup comparison of parametric data. For non-parametric data, “Wilcoxon Signed Rank Test” was used for individual group and “Mann Whitney ‘U’ test” was used for intergroup comparison.

The obtained results were interpreted as follows:

Interpretationp Value
Insignificantp ≥ 0.05
Significant0.001 ≤ p < 0.05
Highly significantp < 0.001

Overall Assessment Criteria

The overall results were categorized in terms of percentage relief as follows :

Complete Remission100% relief
Marked Improvement>75% relief
Moderate Improvement51% to 75% relief
Mild Improvement25% to 50% relief
No Improvement< 25% or No relief

Results

Intergroup Comparison of Subjective Parameters:

Criteria% Reliefp valueSignificance
Group I (n=20)Group II (n=20)
1. Inattention
1a.58.952.30.818IS
1b.48.753.80.218IS
1c.53.867.30.464IS
1d.47.247.20.989IS
1e.45.142.20.329IS
1f.62.861.50.839IS
1g.33.3500.052IS
2. Hyperactivity
2a.25.547.20.316IS
2b.5265.50.448IS
2c.51.561.90.136IS
2d.47.552.70.069IS
2e.5052.20.316IS
2f.21.644.40.393IS
3. Impulsivity
3g.40500.568IS
3h.43.2530.049S
3i.47750.489IS

Effect of Therapy on Objective Parameters:

Group I

InvestigationsGroupsMean Scored% of change±S.D.p valueResult
BTAT
HaemoglobinGroup I14.42514.3950.030.1040.6190.915IS
Group II13.12513.1150.010.1140.9310.943IS
TLCGroup I7.7107.0100.7009.0791.7380.087IS
Group II7.0456.8070.2383.3782.9780.725IS
SGOTGroup I27.1526.950.20.7394.6750.850IS
Group II30.6530.000.652.12012.8610.824IS
SGPTGroup I23.0522.800.251.084.0380.785IS
Group II22.5020.5028.8812.4650.482IS
S. CreatinineGroup I0.7150.6350.08011.100.1772.027IS
Group II0.6850.6550.0304.370.2230.554IS
B. UreaGroup I21.8521.800.050.223.6630.952IS
Group II27.9025.402.508.9612.3440.376IS

Effect of Therapy on Subjective Criteria

CriteriaGroupsMean ScoreDiff% change±S.DWPResults
BTAT
1. Inattention
1a.Group I1.950.81.1558.90.813-120<0.001HS
Group II2.111.152.30.718-136<0.001HS
1b.Group I2.051.05148.70.858-105<0.001HS
Group II2.61.21.453.80.995-136<0.001HS
1c.Group I2.61.151.453.80.605-190<0.001HS
Group II2.30.751.5567.30.759-171<0.001HS
1d.Group I1.80.950.8547.20.813-78<0.001HS
Group II1.80.950.8547.20.813-78<0.001HS
1e.Group I1.550.80.745.10.716-78<0.001HS
Group II2.251.30.9542.20.759-105<0.001HS
1f.Group I1.750.651.162.80.968-78<0.001HS
Group II1.950.751.261.50.894-120<0.001HS
1g.Group I0.90.60.333.30.470-210.031S
Group II1.60.80.8500.768-78<0.001HS
2. Hyperactivity
2a.Group I2.151.60.5525.50.510-66<0.001HS
Group II1.80.950.8547.20.813-78<0.001HS
2b.Group I1.250.60.65520.671-66<0.001HS
Group II1.450.50.9565.50.999-66<0.001HS
2c.Group I1.650.950.8542.40.571-91<0.001HS
Group II2.10.81.361.90.979-105<0.001HS
2d.Group I21.050.9547.50.826-91<0.001HS
Group II2.751.31.4552.70.686-171<0.001HS
2e.Group I1.70.90.85500.834-66<0.001HS
Group II2.21.051.1552.20.196-105<0.001HS
2f.Group I1.851.450.421.60.598-28<0.016S
Group II1.350.750.644.40.681-55<0.002S
3. Impulsivity
3g.Group I0.750.450.3400.571-150.063IS
Group II0.90.450.45500.686-280.016S
3h.Group I1.851.050.843.20.696-91<0.001HS
Group II2.451.151.3530.733-153<0.001HS
3i.Group I0.850.450.4470.503-360.008S
Group II10.250.75751.020-450.004S

Overall Effect of Therapy:

Overall EffectGroup IGroup IITotalPercentage
N = 20%N = 20%
Marked Improvement000105 %12.5 %
Moderate Improvement735 %1155 %1845 %
Mild Improvement1050 %630 %1640 %
No Improvement315 %210 %512.5 %

Discussion

Discussion on Probable mode of action of the trial drug

The mode of action of a drug depends upon its Rasa, Guna, Virya, Vipaka or Prabhava.

Present research work was conducted on Madhuyashti Granules and Shirodhara. To give a contemporary touch to the conventional dosage form, the usage of powdered Madhuyashti with milk has been replaced by developing a novel formulation, Madhuyashti Granules.

This formulation is not only milk soluble but also stable, well-preserved and palatable. In the present study, an effort was made to prepare a palatable, well-preserved and easily administrable formulation of Madhuyashti Churna as Madhuyashti Granules and to standardize the same.


Probable mode of action of Madhuyashti Granules

Madhuyashti is a significant herb with various therapeutic properties that make it particularly beneficial in managing ADHD. ADHD can be associated with an imbalance in Vata and Pitta Doshas, manifesting as symptoms like hyperactivity, impulsivity, restlessness and difficulty focusing. The Madhura Rasa and Guru Guna of Madhuyashti work to stabilize and ground the mind, counteracting the erratic nature of Vata imbalance. Its Sheeta Virya also soothes and calms the intense, fiery nature of Pitta, which is often linked to irritability, frustration and impulsivity seen in ADHD.

Madhuyashti, which is one among the Medhya Rasayanas, enhances cognitive function, memory and intellect. This makes it particularly useful in ADHD, where cognitive clarity and focus are often impaired. Furthermore, its Snigdha Guna nourishes the mind and nervous system, offering a calming effect that helps reduce hyperactivity and anxiety. The herb is also believed to strengthen the Ojas, the vital essence responsible for immunity, vitality and mental resilience, which is crucial in enhancing mental clarity and emotional stability in ADHD.

The neuroprotective effects of Madhuyashti, attributed to its glycyrrhizin and flavonoid content, help protect neurons from oxidative stress, a factor that can contribute to cognitive and behavioural issues in ADHD. Its anti-inflammatory properties may reduce neuroinflammation, potentially improving cognitive function and behaviour. Furthermore, Madhuyashti may modulate neurotransmitter levels, particularly dopamine and serotonin, which are known to play a vital role in ADHD. By influencing these neurotransmitters, Madhuyashti might help manage symptoms like impulsivity and hyperactivity.

Moreover, Madhuyashti has adaptogenic properties that support the body's resistance to stress, which is often heightened in individuals with ADHD. This stress-reducing effect can have a calming impact, improving the overall symptom profile. Additionally, Madhuyashti supports adrenal health, which is vital for the body's stress response. Balanced adrenal function can help reduce fatigue and anxiety, common coexisting symptoms with ADHD. Thus, Madhuyashti, through its multifaceted actions, offers a holistic approach to managing ADHD,

aiding in calming the mind, improving focus, reducing impulsivity and enhancing cognitive function.

Samprapti Vighatana of Unmada by Madhuyashti Granules

jaims_4124_01.JPG

Probable mode of action of Shirodhara

Shirodhara is a traditional Ayurvedic therapy that offers a holistic approach to managing ADHD through its calming and balancing effects on the body and mind. The rhythmic and soothing flow of warm oil onto the forehead helps pacify the Doshas by calming the central nervous system. This deep relaxation can reduce hyperactivity and impulsivity, while also soothing the mind, thus mitigating symptoms like irritability and frustration commonly associated with Pitta imbalance.

In addition to balancing the Doshas, Shirodhara promotes mental stillness and clarity, enhancing focus and concentration, which are often impaired in individuals with ADHD. The therapy's stress-reducing effects, achieved through the regulation of cortisol levels, further contribute to a calmer mental state,


which can positively impact behavioural and emotional symptoms. Furthermore, Shirodhara improves sleep quality, a critical factor in managing ADHD, as sleep disturbances often exacerbate the condition's symptoms.

Shirodhara also supports emotional stability by calming the mind and nervous system, helping to manage mood swings, irritability and frustration. It fosters a deeper connection between the mind and body, promoting mindfulness and self-regulation, which are essential for individuals with ADHD. Additionally, the therapy enhances Ojas, the vital essence responsible for immunity, mental resilience and overall vitality, further supporting mental stability and resilience to stress.
jaims_4124_02.JPG
From a modern scientific perspective, Shirodhara's ability to reduce stress, activate the parasympathetic nervous system, improve sleep quality and regulate mood aligns with the management of ADHD.

The therapy may also influence neurotransmitter levels, particularly dopamine and serotonin, which are crucial for mood regulation and attention. Moreover, the repetitive, rhythmic nature of Shirodhara may enhance neuroplasticity, improving cognitive function and behavioural regulation. Overall, Shirodhara provides a non-invasive, complementary therapy that can be integrated into an Ayurvedic treatment plan to help manage ADHD symptoms, improve focus, reduce anxiety and enhance overall quality of life.

Conclusion

The rising prevalence of ADHD in younger age groups is a growing concern. Contributing factors include increased awareness, improved diagnostic practices and lifestyle changes, such as greater digital media exposure and reduced physical activity, which may exacerbate ADHD symptoms. As per Ayurveda, ADHD is an imbalance in Vata predominant Tridoshas, with traditional treatments focusing on restoring balance through diet, lifestyle modifications, herbal remedies and practices like Yoga and meditation.

In Group I, 35% patients showed moderate improvement, 50% showed mild improvement and 15% showed no improvement. In Group II, 5% of patients showed marked improvement, 55% showed moderate improvement, 30% showed mild improvement and 10% showed no improvement. In a study involving 40 patients, the clinical outcomes were statistically significant in both Group I and Group II on the subjective criteria.

However, Group II, where patients managed with both Madhuyashti Granules and Shirodhara,, showed slightly better result than Group I, where patients were managed with only Madhuyashti Granules. The comparisons between the two groups showed insignificant results. In clinical practice, combining drug therapy with non-pharmacological approaches such as counselling and cognitive-behavioural therapy can improve the quality of life for ADHD patients. No untoward effect of trial drug was observed during the entire study period.

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