E-ISSN:2456-3110

Research Protocol

Mentosoothe Compound

Journal of Ayurveda and Integrated Medical Sciences

2023 Volume 8 Number 7 July
Publisherwww.maharshicharaka.in

Clinical study to evaluate the efficacy of Mentosoothe Compound in the management of Attention Deficit / Hyperactivity Disorder

Kumawat S.1*, Kumar Nagar R.2, Nandlal Prajapati V.3
DOI: http://dx.doi.org/10.21760/jaims.8.7.6

1* Shraddha Kumawat, Post Graduate Scholar 2nd Year, Department of Kaumarbhritya, National Institute of Ayurveda, Deemed to be university (De-novo), Jaipur, Rajasthan, India.

2 Rakesh Kumar Nagar, Associate Professor, Department of Kaumarbhritya, National Institute of Ayurveda, Deemed to be university (De-novo), Jaipur, Rajasthan, India.

3 Vishal Nandlal Prajapati, Assistant Professor, Department of Kaumarbhritya, National Institute of Ayurveda, Deemed to be university (De-novo), Jaipur, Rajasthan, India.

Introduction: DSM-5 defines Attention-Deficit/Hyperactivity Disorder as having a persistent pattern of hyperactivity or inattention. This affects social, emotional, cognitive, and academic performance, behavioural skills in children and adolescents. The suffering child should have more than 6 symptoms of a particular type. Due to aetiology of Dhee Dhriti and Smriti, which results in imbalance of Kala and Karma and leads to incorrect interaction of the senses with their aims (Asatmyendriyartha Samyoga), gives rise to inattention, hyperactivity and impulsivity. Considering the nature of symptomatologic manifestation, it can be correlated with Unmada, more specifically Vata-Pittaja Unmada. Ayurveda addresses ADHD with both internal medicines and external therapies. Mentosoothe compound is such a polyherbal compound it contains Medhya, Balya, Deepana and Rasayana drugs in extract form. Aim of the present study to evaluate the efficacy of mentosoothe compound in the management of Attention-Deficit/Hyperactivity Disorder. Objective of the study is to promote cognitive performance with improvement in the quality of life by providing an effective and safe treatment option. Materials and Methods: The present study will be conducted as a randomized clinical study including minimum 40 patients, divided into two groups. Mentosoothe compound A and Mentosoothe compound B will be given to groups with fixed dosages. Assessment will be done on every 15th day during 2 months of clinical trial and final follow up will be done one month after completion of clinical trial. Result: The results will give the data on comparative effectiveness of the Mentosoothe compounds on ADHD. Discussion and Conclusion: The outcome of this trial will render a way forward to effective management of ADHD in children.

Keywords: ADHD, Unmada, Mentosoothe Compound, Medhya

Corresponding Author How to Cite this Article To Browse
Shraddha Kumawat, Post Graduate Scholar 2nd Year, Department of Kaumarbhritya, National Institute of Ayurveda, Deemed to be university (De-novo), Jaipur, Rajasthan, India.
Email: 		Shraddha Kumawat, Rakesh Kumar Nagar, Vishal Nandlal Prajapati, Clinical study to evaluate the efficacy of Mentosoothe Compound in the management of Attention Deficit / Hyperactivity Disorder. J Ayu Int Med Sci. 2023;8(7):37-41.
Available From
https://jaims.in/jaims/article/view/2504

Manuscript Received Review Round 1 Review Round 2 Review Round 3 Accepted
2023-05-29 2023-05-31 2023-06-07 2023-06-14 2023-06-21
Conflict of Interest Funding Ethical Approval Plagiarism X-checker Note
Nil Nil Yes 19%

© 2023by Shraddha Kumawat, Rakesh Kumar Nagar, Vishal Nandlal Prajapatiand 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].

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Introduction

Attention-Defecit/ Hyperactivity Disorder is a condition in which according to Diagnostic and Statistical Manual for Mental Disorder (DSM-5) of American Psychiatric Association (APA), ADHD is characterized by persistent pattern of inattention or hyperactivity/impulsivity.[1] It is one of the most common neurodevelopmental disorders in children and adolescents which affect the social, learning and behavioral abilities, with increasing incident rate. The global estimated prevalence of this disorder is 5.29%, in India it ranges from 2-17%,[2] in Jaipur 9.7%,[3] 5-10% in children and 4-6% in adults.[4] The American Academy of Pediatrics recommends evaluating any child between 4 and 18 years of age for ADHD.[5] The disorder is often chronic with one third to one half of those affected, retaining the condition into adulthood.[6] An improper synchronization of functional neurons and their antecedent neural dynamics in the human brain as well as neurophysiological human mind can cause a wide range of attention deficit problems.[7] Strong genetic component is important factor results in the disease. Antenatal history of Mother may include birth complication such as prolonged labor, toxemia, and complicated delivery. Drug abuse and addiction of mother are also being recognized as risk factors. However, the precise etiological reason for ADHD is uncertain. Brain traumas, low birth weight, birth asphyxia, trauma, brain abnormalities, lack of family discipline, food additives, toxic substances, etc. are known to have some part in its development. It has been linked to a wide range of negative effects in those affected, as well as a significant financial cost on families and society, making it a significant public health issue. Untreated ADHD can have a number of negative emotional and physical effects, such as low self-esteem, mishaps, injuries, drug usage, sleep issues, enuresis, anxiety, autistic spectrum disorder, and learning impairments. Lack of sleep, stress, excessive stimulation and inappropriate use of technology are some of the major triggers of ADHD.[8] There are several ways to manage ADHD but pharmacotherapy is standard approach, which includes psychostimulant drugs like amphetamine/methylphenidate and tricyclic antidepressants (TCAs) such as imipramine and nortriptyline. These drugs have some major side effects, like methylphenidate can cause loose motions, anorexia, insomnia etc.,

whereas TCAs can cause anticholinergic side effects like dry mouth, weight gain, convulsions etc.[9] The results with these approved medications for ADHD are often unsatisfactory. FDA has approved Viloxazine (Qelbree) a new nonstimulant, nonscheduled drug to treat attention-deficit/hyperactivity disorder (ADHD) in children and adolescents.[10]

In recent years various publications in Ayurveda have investigated this subject and found significant results in term of effectiveness. In Ayurveda there are no direct references of ADHD but some references about abnormal behavior are discussed under features of Unmada- Mano Vibhrama, Buddhi Vibhrama, Smriti Vibhrama, Sheela Vibhrama, Cheshta Vibrama and Achara Vibhrama, and considering nature of symptomatological manifestation, it can be correlated with Unmad. It is a Vata-Pitta Pradhan Sarva-Dosha (Sharirik+Mansik) Prakopak Vyadhi.

This is a Manovaha Sroto Vikara with predominance of Raja and Tama Guna.[11] Acharya Kashyap in Vedna-Adhyay has also mentioned Pralap, Vaichitya, Arti in Unmada Vyadhi.[12] Further, the features of Rakshas Rajasik Manas Prakriti and Matsya Tamsik Manas Prakriti are almost on the same wavelength of ADHD. The causes may be the vitiation of Dhee (rational thinking), Dhriti (intellect/retaining power of mind), Smriti (memory) which leads to abnormal behavior such as inattention, hyperactivity, and impulsivity etc. due to improper contact of senses with their objectives.[13] With different aspect knowledge of ADHD in Ayurveda. With ancient treasure of knowledge, there come newer dimensions for treating ADHD. Hence the drugs which are Tridosha-Shamak, Manas Dosha Chikitsa (Dhee, Dhriti, Smriti, Jyan, Vijyan, Sukhakar Shabda etc.), Medhya Rasayan, Panchakarma procedures like Shirodhara, Basti, Nasya etc. that gives stability to all components of Mana (Dhee, Dhriti, Smriti) will have better effect on ADHD. Understanding the efficacy of Ayurveda intervention i.e., modification of diet, drug according to Prakriti, may allow appropriate options and improve the quality of life of the child.

The trial drug of the present study is Mentosoothe compound A which contains drugs such as Tagar (Valeriana wallichii DC), Vacha (Acorus calamus Linn.), Brahmi (Bacopa monnieri Linn.), Ashwagandha (Withania somnifera Linn), Trikatu


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Kumawat S et al: Efficacy of Mentosoothe Compound in the management of Attention Deficit

[Pippali (Piper longum Linn.), Marich (Piper nigrum Linn.), Shunthi (Zingiber officinalis Roxb)], while Mentosoothe compound B contains drugs such as Jatamansi (Nardostachys Jatamansi DC.), Shankhpushpi (Convolvulus pluricaulis Chois.), Guduchi (Tinospora cordifolia Willd.), Chitrak (Plumbago zeylanica Linn), Trikatu [Pippali (Piper longum Linn.), Marich (Piper nigrum Linn.), Shunthi (Zingiber officinalis Roxb)]. It contains Medhya, Rasayan, Balya Dravyas which are known to be beneficial in making proper synchronization of neurons, and hence can be very effective in ADHD.

Materials and Methods

The study will be conducted under a strict protocol to prevent bias and to reduce the source of error in study. Following materials and methods will be adopted for conducting the present clinical trial.

Selection of Cases for Clinical Trial

  • Source - Subjects will be randomly selected from O.P.D & I.P.D of Balarog/Kaumarbhritya Dept. of N.I.A Jaipur and associated hospital
  • Sample size - 40 (20 in each group) [Sample size according to prevalence (9.7%) in Jaipur is approx. 126, but due to limitation of funds we will take 40 subjects]
  • Study type - Double blind, Randomized, Comparative Trial
  • Method of allocation concealment - Sequentially numbered, opaque, sealed envelopes (SNOSE)

Diagnostic Criteria: Pre diagnosed subjects of ADHD or subjects those having clinical features of ADHD will be screened on the basis of DSM 5 (Diagnostic and Statistical Manual for Mental Disorders Vol-5).

Inclusion Criteria

1. Children of either sex in between age group of 5 to 10 years.

2. Known case of ADHD.

3. Children with average/normal IQ

4. Subjects satisfying DSM-5 criteria of diagnosis

Exclusion Criteria

1. Children with any critical mental diseases.

2. Children with known gross physical disability.

3. Children with any known genetic disorder and congenital disorder.

4. Children with any associated long term or fatal disease

5. Children with known systemic disorder like Diabetes Mellitus, Nephrotic syndrome etc.

Execution Plan of Study

Dose and Duration

  • Dose - 250 mg BD
  • Route - Oral
  • Duration - 3 months (2-month clinical trial + 1 month post clinical period)
Group A Group B
Mentosoothe compound A Volume in each capsule (250 mg) Mentosoothe compound B Volume in each capsule (250 mg)
Tagar ⃰ 56.25 mg Jatamansi ⃰ 56.25 mg
Vacha ⃰ 56.25 mg Shankhpushpi ⃰ 56.25 mg
Brahmi ⃰ 56.25 mg Guduchi ⃰ 56.25 mg
Ashwagandha ⃰ 56.25 mg Chitrak ⃰ 56.25 mg
Trikatu 25 mg Trikatu 25 mg

* Aqueous extract

Criteria for discontinuing or modifying allocated interventions will be withdrawal from intervention if any harmful incidence, signs of drug allergy or any problem will occur, if the patient is not willing to participate in trial study, then the patient also have right to discontinue the treatment. The primary outcomes of the effect of trial drugs Mentosoothe compound A and Mentosoothe compound B will be assessed on the basis of change in scoring/grading of symptom of ADHD on NICHQ Vanderbilt Assessment scale.

Result

Subjects will be enrolled from August 2023. The study will be completed within one and half year following the registration of first case. The statistical analysis will be based on appropriate statistical tools. The expected results will give the data on comparative effectiveness of the mentosoothe compounds on ADHD.

Discussion

The present study comprises comparison of the efficacy of two mentosoothe compounds


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Kumawat S et al: Efficacy of Mentosoothe Compound in the management of Attention Deficit

on ADHD. Most of these drugs have Tikta, Kashaya Rasa, Katu Vipaka and Ushna Virya and Medhya properties.

Probable mode of action of the drugs

Tikta Rasa is predominant in Vayu and Akasha Mahabhuta. These Mahabhuta helps in clearing the Srotorodha by reducing Kapha, thereby reducing Tama Guna which increases Sattva Guna. Kashaya Rasa is predominant in Vayu and Prithvi Mahabhuta, later has property called Sthira Guna provides the stability in hyperactivity and impulsivity. Laghu Guna is predominant In Vata Mahabhuta. By lowering Tama, it strengthens Sattva. It has Deepana property that causes Agni to grow as Mandagni corrodes Sattva, Raja, and Tama. By boosting Vata, Katu Vipaka aids in the elimination of Prakupita Kapha, which is the cause of inattention. Most of these medications are Tridoshahara, which means they stabilize Sattva Guna by balancing all the Doshas. Kapha is lessened by Ushna Veerya, and Tama and Raja Guna follow. Some medications increase Sthira Guna in the body by having Madhura Vipaka, which reduces a child’s restless conduct. These medications also contain Medhya characteristics, which are known to have nootropic effects such as improving cognition, memory, reasoning skills, and other intellectual abilities.

Mentosoothe compound A contains Tagar, Vacha, Brahmi, Ashwagandha, Trikatu. Tagar is known to have Beneficial effect on performance and alertness,[14] Vacha have Antidepressant[15] Neuroprotective,[16] Brahmi possess Improves motor learning, acquisition[17] Psycho-neurological deficits,[18] There is evidence that Ashwagandha has Calm down anxiety, Control inattention, Hyperactivity, impulsivity and distractibility.[19]

Mentosoothe compound B contains, Jatamansi which has Antioxidant, Sedative, Tranquilizing, Antidepressant-activity, Anticonvulsant-activity,[20] Shankhpushpi posses’ Neuroprotective activity, Intellect promoting activity, Antioxidant activity, enhances memory function,[21] Guduchi known to have Learning and memory enhancing activity,[22] Neuro-protective activity Antioxidant activity, Anti-stress activity,[23] Chitrak is evident to have Antioxidant,[24] memory enhancing effect, CNS stimulation,[25] Trikatu known to have Bioavailability enhancement activity, Immunomodulatory, Antioxidant,[26]

properties. Trikatu is a combination of three herbs - ginger, black pepper, and long pepper - that is commonly used in Ayurvedic medicine to improve digestion and reduce inflammation. While there is limited research on Trikatu's effect on ADHD specifically, it may be beneficial in reducing inflammation in the brain and improving overall health, which may indirectly improve ADHD symptoms.

Both the groups have drugs which acts as Medhya and involved in enhancement of cognition, intellect and behavioural activity. By this study we are trying to get a compound that is more effective than the other in the management of ADHD. Ashwagandha, Shankhpushpi, Brahmi, Tagar, Vacha, Guduchi, Trikatu, and Chitrak are all herbs that have been traditionally used in Ayurvedic medicine for various health benefits. One potential benefit of using natural remedies for ADHD is that they may have fewer side effects than prescription medications. Stimulant medications, such as methylphenidate and amphetamines, can cause side effects such as decreased appetite, insomnia, and headaches. Natural remedies may be a safer alternative for individuals who experience side effects from prescription medications.

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