Survey and intervention study to evaluate the efficacy of Ayurvedic...

[Full title: Survey and intervention study to evaluate the efficacy of Ayurvedic formulation and Shirodhara in Attention Deficit Hyperactivity Disorder]

[Find the meaning and references behind the names: Rakesh Kumar, Omprakash, Bala, Shri, Priyanka, Muskan, Kumar, Rakesh, Gautam]

ORIGINAL ARTICLE September 2023 Journal of Ayurveda and Integrated Medical Sciences | September 2023 | Vol. 8 | Issue 9 65 Survey and intervention study to evaluate the efficacy of Ayurvedic formulation and Shirodhara in Attention Deficit Hyperactivity Disorder Omprakash Bairwa 1 , Rakesh Kumar Nagar 2 , Priyanka Gautam 3 1 Assistant Professor, Dept. of Kaumarbhritya, Shri Dhanwantri Ayurvedic Medical College & Research Centre, Mathura, Uttar Pradesh, India. 2 Associate Professor, Dept. of Kaumarbhritya, National Institute of Ayurveda, Jaipur, Rajasthan, India. 3 Assistant Professor, Dept. of Dravyaguna, Shri Dhanwantri Ayurvedic Medical College & Research Centre, Mathura, Uttar Pradesh, India. I NTRODUCTION Ayurveda is an eternal, scientifically time-tested ancient science that has been systematically divided into eight clinical branches as evidenced from the literature. Among the eight literature of Ayurveda , Kaumarbhritya or Bala Chikitsa has been mentioned with prime importance and compared to Agnidevta . In Kashyapa Samhita , Acharya Kashyapa placed Kaumar- Address for correspondence: Dr. Omprakash Bairwa Assistant Professor, Dept. of Kaumarbhritya, Shri Dhanwantri Ayurvedic Medical College & Research Centre, Mathura, Uttar Pradesh, India. E-mail: op.muskan@gmail.com Submission Date: 18/07/2023 Accepted Date: 27/08/2023 Access this article online Quick Response Code Website: www.jaims.in DOI: 10.21760/jaims.8.9.11 -bhritya above all the other eight branches Childhood is a period in which growth and development are at their peak level. Any factor may be affecting this period not only the growth of a child but also its activities, social behaviour, concentration power, immunity, and school performance. Symptoms of ADHD are one of the leading causes of academic underachievement in children and disturbed concentration. This is the major concern for the parents to visit the paediatrician. Attention deficit hyperactivity disorder (ADHD) is a neurodevelopment disorder characterized by persistent hyperactivity, impulsivity, and inattention that significantly impairs educational achievement or social functioning [1] It is one of the most common and most extensively studied behavioral disorders in school-age children. Genetic, epigenetic, and environmental factors interact to give rise to ADHD phenotypes. Biological and psychosocial factors also contribute to ADHD. Prenatal exposure to alcohol, A B S T R A C T Attention deficit hyperactivity disorder (ADHD) is a mental disorder of the neuro-developmental type. The core symptoms of ADHD are inattention, hyperactivity, and impulsivity. It is one of the most common and most extensively studied behavioral disorders in school-age children. In this study and Ayurvedic formulation ‘Tab. Eleva’, showed extremely significant improvement in Inattention, Hyperactivity, and Impulsivity as well as on the Diagnostic and Statistical Manual of Mental Disorder IV edition (DSM – IV) criteria. However, Shirodhara also shows statistically significant improvement in Inattention, Hyperactivity, and Impulsivity but the percentage of relief is less than the Ayurveda formulation. The survey study, conducted with a sample size of 1000 cases, revealed that the prevalence of ADHD among males was 34.35%, while in females it was 10.64%, within the age range of 6-12 years. Key words: Attention Deficit Hyperactivity Disorder (ADHD), Inattention, Hyperactivity, Impulsivity, Shirodhara

[Find the meaning and references behind the names: Pir, Peer, Ayu]

Omprakash Bairwa et al. Survey and intervention study in Attention Deficit Hyperactivity Disorder ISSN: 2456-3110 ORIGINAL ARTICLE September 2023 Journal of Ayurveda and Integrated Medical Sciences | September 2023 | Vol. 8 | Issue 9 66 cocaine, and nicotine are associated with ADHD phenotypes. Recent functional magnetic resonance imaging (MRI) brain studies indicate that the disorder may be caused by atypical functioning in the frontal lobe, basal ganglia, corpus callosum, and cerebellar vermis. Pharmacological studies have also implicated dysregulation of frontal – subcortical – cerebellar catecholaminergic circuits (dopamine and norepinephrine neurotransmitter system) in the pathophysiology of the disorders [1] Attention deficit hyperactivity disorder has strong familial associations. Parents and siblings of a child with ADHD carry a 2 to 8-fold increase in the risk for ADHD. Core symptoms of ADHD challenge school-related activities and tasks, relationships, and other functions. Cognitive impairments include a lack of impulse control and a deficit in attention, memory, organization, time management, and judgment. Activity limitations include difficulties in learning and applying knowledge (reading, writing, and mathematics), problems with carrying out single or multiple tasks, studying, and selfmanaging behaviour. Attention deficit hyperactivity disorder also impacts interpersonal interaction; communication and self-care; adjusting and succeeding in educational programs; leaving school to enter work; and establishing a community, social, and civic life. Children with ADHD have been found to have a significant functional impairment in the areas of academic achievement, family relationships, peer relationships, self-esteem and self-perception, accidental injuries, and overall adaptive function. It may be due to the self-esteem of children with ADHD is often lower than their peers. Children with ADHD often receive high levels of negative peer rankings of social standings [2] The prevalence of ADHD depends on the precise definition adopted and methods used for evolution. The most common evolutionary method is DSM IV (Diagnostic and Statistical Manual- IV) [3] Incidence in school-aged children 3-5% (Estimated ranged from 1% - 20%). Boys : Girl’s ratio is 4:1 (More prevalent in boys). ADHD occurs with association with other disorders in childhood. ▪ 50% = oppositional disorders. ▪ 30-40% = conduct disorders. ▪ 20-25% = Anxiety disorders. ▪ 10-15% = Mood disorders. ▪ 10-20% = Learning disabilities. ▪ In adolescence, it may be associated with substance abuse disorders [4] Considering the present scenario of the high prevalence of ADHD among behavioural disorders, its ill outcomes in multiple areas of a child’s functioning, and lack of safe and effective medication, the disease ADHD has been selected for the proposed study. For the psychotic disorder, Ayurveda explained a lot of range in the formulation, and treatment procedure. Jyotishmati ( Celastrus paniculatus ) , Akarkara ( Anacyclus pyrethrum ) , Vacha ( Acorus calamus ), and Gandira ( Coleus forskohlii ) are some of the best drugs for psychotic disorders and Shirodhara is known as best therapy for the controlling & regularization of the brain functions. In the present study, Tab. Eleva and Shirodhara are proposed to evaluate the efficacy in known ADHD patients. Table 1: Contents of Tab. ELEVA (Dr. Vasishth’s Ayu Remedies) [5] SN Name of Drug Latin name Family Useful part Ratio (in %) 1. Jyotishmati Celastrus paniculatus Celastraceae Seed and oil 250 mg 2. Akarkara Anacyclus pyrethrum Asteraceae Root 150 mg 3. Vacha Acorus calamus Araceae Root & Rhizome 50 mg 4. Gandira Coleus forskohlii Lamiaceae Whole plant 50 mg A IM AND O BJECTIVES 1 To study the prevalence of ADHD in school children (6-12 years) in Jaipur, Rajasthan

[Find the meaning and references behind the names: Honey]

Omprakash Bairwa et al. Survey and intervention study in Attention Deficit Hyperactivity Disorder ISSN: 2456-3110 ORIGINAL ARTICLE September 2023 Journal of Ayurveda and Integrated Medical Sciences | September 2023 | Vol. 8 | Issue 9 67 2 To study the gender difference in the prevalence of ADHD 3 To assess the clinical efficacy of tab. Eleva (Dr.Vasishth Pharm.) in ADHD 4 To assess the clinical efficacy of Shirodhara in ADHD 5 To provide relief in the symptoms of ADHD M ATERIALS AND M ETHODS Phase 1: Cross-sectional, School-based survey study to assess the prevalence of ADHD in school children (6-12 years) of Jaipur city for 08 Months and sample size - Maximum number of 1000 students will be included (10% of non-response error 100) Statistical Analysis of the Survey will be done by using Statistical Product and Service Solution (SPSS) 20.0 software. Phase 2 : To evaluate the Clinical efficacy of Tab. Eleva and Shirodhara in ADHD patients. An open randomized parallel clinical study. Selection of Cases 1 Source of Patients: All affected children for the present study were selected from OPD of the PG Department of BalRoga , National Institute of Ayurveda , Jaipur, and several schools, located in Jaipur by survey method. 2 Age group: Children between 6 to 12 years were included in the study. 3 Number of cases: 34 patients are registered for clinical trial, 04 patients were left from the trial because they have not completed their follow-ups. 4 Grouping of Patients: Group A: This group of 17 Children was given the Ayurvedic formulation Tab. Eleva 1 Tablet twice a day with Honey after meal for 3 months. Group B: This group of 17 Children was given the Shirodhara (Ksheerdhara) procedure for 15 days followed once a week for 3 months in the morning with milk for 45 Minutes Diagnostic Criteria ADHD-suffering children were screened via preassessment criteria based on DSM IV (Revised) [3] (Diagnostic and Statistical Manual for Mental Disorders.) A. Inclusion Criteria 1 School children aged between 6 to 12 years of both sexes having fulfilled DSM IV criteria. 2 Having signs and symptoms for ADHD. 3 Children with average/normal IQ B. Exclusion Criteria 1 Children with known physical disability (deafness or visual problems) 2 Children with psychiatric disorders 3 Children with gross brain damage causing mental retardation. 4 Children with any genetic disorder 5 Children with, epilepsy, chronic medication (e.g. steroids), previous history of an infectious disease involving the central nervous system (e.g. encephalitis), intellectual disability, and autism 6 Unreliable history. C. Discontinuation Criteria 1 Parents not willing to continue the treatment 2 Any acute or severe illness. D. Assessment Criteria 1 DSM. IV criteria 2 Attention span by Coefficient of Division 3 Reaction time 4 Finger Dexterity test 5 IQ assessment E. 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 loss of

[Find the meaning and references behind the names: Man]

Omprakash Bairwa et al. Survey and intervention study in Attention Deficit Hyperactivity Disorder ISSN: 2456-3110 ORIGINAL ARTICLE September 2023 Journal of Ayurveda and Integrated Medical Sciences | September 2023 | Vol. 8 | Issue 9 68 appetite, insomnia, sleep, irritability, drowsiness, headache, anxiety, etc. Material & Methods adopted for Diagnosis Material ▪ A pre-assessment questionnaire was made based on DSM IV criteria, which included 18 questions, which were filled out by school teachers & parents of the children. ▪ Division of Attention Board (Electrical) – For Attention Spasm. (Pic. No. 01) ▪ Vernier Chronoscope (Electrical) – For Assessment of Reaction Time. (Pic. No. 02) ▪ Finger Dexterity Board with pins – For Assessment of Motor Ability. (Pic. No. 03) ▪ ‘Draw– A –Man’ Test for Indian children for assessing the IQ of the children. Pic. 1: Division of attention board (electrical) Pic. 2: Vernier Chronoscope Pic. 3: Finger Dexterity Methods By survey method, ADHD-affected children were screened out through a questionnaire (which had 18 questions out of which 9 for hyperactivity and impulsivity and 9 for inattention) based on DSM IV criteria for ADHD. The questionnaire was filled out by teachers and parents of children in which scoring more than or equal to 6 points in each category were further assessed for IQ (Intelligence Quotient) For IQ assessment ‘Draw – A – Man’ Test was adopted for Indian children and is valid for children of age group 4-15 years. Children with average or above IQ were considered for further screening. Screened children by pre-assessment questionnaire and average IQ or above average IQ were further screened by DSM IV criteria. 6 (or more) out of 9 criteria (symptoms) of inattention, persisted for at least 6 months to a degree that is maladaptive and inconsistent with development level were considered as positive assessment for ADHD. Similarly, six (or more) of the symptoms of hyperactivity-impulsivity persistent for at least 6 months to a degree that is maladaptive and inconsistent with developmental level were considered positive assessments for ADHD. Screened-out children were given three tests, namely- 1 Test for inattention span - performed by an instrument Division of Attention Board (electrical) 2 Test for reaction time - performed by an instrument Vernier Chronoscope (electrical)

[Find the meaning and references behind the names: Sara, Venkata, Ramya, Shakti]

Omprakash Bairwa et al. Survey and intervention study in Attention Deficit Hyperactivity Disorder ISSN: 2456-3110 ORIGINAL ARTICLE September 2023 Journal of Ayurveda and Integrated Medical Sciences | September 2023 | Vol. 8 | Issue 9 69 3 Test for finger dexterity for motor ability - performed by an instrument “Finger Dexterity Board with Pins Detailed information about the diagnosed children was recorded in Performa and prepared based on standard Ayurvedic parameters as well as modern. The information included immunization schedule, perinatal & post-natal history, history of past illness, socioeconomic status, family and personal histories like appetite and bowel status, developmental milestones, Sattva , Sara , Samhanana , Ahar Shakti , Vyayam Shakti and all Ayurvedic parameters. Institutional Ethics Committee (IEC) Clearance Approval for the design of the study and ethical clearance was obtained from the Institutional Ethical Committee of N.I.A. Jaipur Letter No. IEC/ACA/2017/93 date 26/04/2017, The CTRI (Clinical Trials Registry- India) registration no. is CTRI/2018/05/014001. Phase I O BSERVATIONS Table 2: Showing overall observation of Survey Study Distr. of Patients of ADHD Overall Observation Discussion Age-wise More in 6-9 years i.e., 56.3% and 43.7% in 9-12 years. The prevalence of ADHD disease in primary school children is more and gradually attenuation of symptoms with the advancement of age. Sexwise 52.1% were male and 47.9% were female. In a previous study by Jyothsna Akam Venkata et al [6] Prevalence was found to be higher among the males as compared to that of females. Habitat wise The majority of subjects 81.5% from urban areas and 18.5% of subjects were from rural areas. This is because the study was conducted in an urban area (Jaipur). ADHD type wise maximum 40.43% cases belong According to the previous study by Ramya etal 7 40.43% to the Combined type 2017, the prevalence of combined subtypes of ADHD is maximum. R ESULTS Table 3: Showing age-wise distribution of the Subjects (n=1000) SN Age No With ADHD % with ADHD χ 2 P Value Remark 1. 6-9 Years 563 148 26.28 4.965 0.0259 S 2. 9-12 Years 437 82 18.76 In this study, it was found that out of 563 cases, 148(26.28%) were in the age group of 6-9 years and had ADHD, followed by 82 (18.76%) in 437 children of age group 9-12 years. On statistical analysis relation between age and prevalence of ADHD was found significant (P<0.05). (Table No. 03) Table 4: Showing sex-wise distribution of the Subjects (n=1000) SN Sex No With ADHD % with ADHD χ 2 P Value Remark 1. Male 521 179 34.35 50.476 <0.0001 ES 2. Female 479 51 10.64 Out of 521 male children, 179 (34.35%) has ADHD and out of 479 female children, 51 (10.64%) have ADHD. On statistical analysis relation between sex and prevalence of ADHD was found extremely significant (P<0.0001). (Table No. 04) Phase II O BSERVATIONS Table 5: Showing overall observation of Clinical Study Distr. of Patients of ADHD Overall Observation Discussion Age-wise The maximum number of children 66.66% The prevalence of ADHD disease in primary school children is more and gradually attenuation of

[Find the meaning and references behind the names: Hindu, Zheng, Chang]

Omprakash Bairwa et al. Survey and intervention study in Attention Deficit Hyperactivity Disorder ISSN: 2456-3110 ORIGINAL ARTICLE September 2023 Journal of Ayurveda and Integrated Medical Sciences | September 2023 | Vol. 8 | Issue 9 70 were in the age group 6-9 years symptoms with the advancement of age. Sexwise Maximum numbers of children 70% were male In a previous study by Jyothsna Akam Venkata et al [6] Prevalence was found to be higher among the males as compared to that of females. Religion-wise The majority of patients belonged to Hindu religion- 96.66% of the total subjects Hindu children were more due to the predominance of the Hindu community in the survey area. Because of the higher education level and awareness of parents, they are much more aware of the health and education of their children Habitat-wise Majority of Subjects 70% were from urban area This is because the study was conducted in an urban area (Jaipur). Birth weight wise Maximum number of subjects 50% having a birth weight of 2.5- 3.0 kg The reason behind this, no relation of birth weight could be established in a small sample size. So, for this purpose larger sample size should be selected. Incidences of Immunization Most of the subjects 83.33% completed their immunization as per age Because subjects mostly belong to urban areas, where facility of immunization is easily available and their parents are very aware of the health of their children. Incidences of Dietary Status Subjects 53.33% were vegetarian A study by Hae Dong Woo et al [8] which enlisted the traditional healthy dietary pattern was associated with lower chances of having ADHD Incidences of Agni status Maximum patients 46.66% had Mandagni . 33.33% of Naturally, Kapha is dominant in childhood age when they consume excess oily substances, it Samagni , 13.33% & 6.66% had Tikshna and Vishama Agni respectively. leads to the formation of Aamdosha . Due to this disturbing Agni , Mandagni appears. School performance wise The majority of patients 46.66% showed average school performance, followed by 33.33% of patients who showed poor. The poor and average performance of the subjects directly related to the symptoms of ADHD like easily distracted, lack of concentration, difficulty sustaining attention, etc. Incidences of participation in Extracurricular activities Of most patients, 40% sometimes Extracurricular activities participation, and 23.33% of patients on stimulation participation. Extracurricular activities are directly related to the awareness and activeness of parents. Those parents, who know about the disease and its symptoms, try to shift the orientation of his / her child from destructive activity to constructive participation. Type of Family-wise 56.66% of patients belong to a nuclear type of family while 43.33% belong to a joint family. Lack of parental bonding and emotional support could be the reason for developed stress, anxiety, and sometimes severe neurological consequences like ADHD in a nuclear family. Incidences of birth order Majority of patients 43.33%of 1 st birth order, 30%& 23.33% of 2 nd and 3 rd birth order respectively The reason behind this is that a study of ADHD and birth order provides evidence that birth order does not affect Attention Deficit Hyperactivity Disorder. (Berger I, et al.) [9] Mother agewise incidences 43.33% Child’s mothers' ages were 25-30 years and 30-35 years followed by 10% of them categorized in 35-40 yrs age group. Most subjects present with normal fertile age (25-30 yrs) but the finding of the study by Zheng Chang [10] et al. 2014 showed that all children born to mothers who bore their 1 st child early in their

[Find the meaning and references behind the names: Guna, Max, Tamas, Rasa, Robert, Mana, Good]

Omprakash Bairwa et al. Survey and intervention study in Attention Deficit Hyperactivity Disorder ISSN: 2456-3110 ORIGINAL ARTICLE September 2023 Journal of Ayurveda and Integrated Medical Sciences | September 2023 | Vol. 8 | Issue 9 71 reproductive lives were at increased risk of ADHD. Socioeconomic status wise Max. 50% subjects of middle-class socio-economic status, 30% of middle higher class. The higher socioeconomic status of parents is not supported for children, The previous study Beiderman [11] et al., Chawla [12] PL et al.1981 The child’s parents relationshipwise In a maximum number of cases, 50% had an average Child’s -Parent relationship. 43.33% had a good relationship Parenting is more important than we could ever have imagined. According to study [13] [Robert Winston, London J Prim Care. 2016; 8(1)] Sattva - wise The majority of subjects 56.66% were observed in Madhyama Satva and 26.66% subjects of in Avara Satva According to morphological features like the luster of skin, morbidity incidence, appetite, response during Shirodhara, and activities to obeying commands during follow-ups. Prakriti wise 26.66%of patients have Vata-Pitta Prakriti followed by 20% cases having Pitta - Kapha and Kapha-Pitta Prakriti The behavior of Vata Prakriti individuals is more similar to that of ADHD. The Predominance of Pitta Prakriti over Vata is comparable to the comorbidities and associated problems with ADHD like violence, aggression, antisocial behavior, etc. so it can be concluded that Vata Pitta-Prakriti predisposes to the development of ADHD. Incidences of Subtype of ADHD Maximum no. 80% of patients were combined type According to the previous study [7] Ramya et al. 2017, the prevalence of combined subtype of ADHD is maximum Regarding the probable mode of action of drug The effect attained by the study drug can be explained by multiple mechanisms. The ingredients of Tab. ELEVA is a combination of Jyotishmati ( Celastrus paniculatus ) , Akarkara ( Anacyclus pyrethrum ) , Vacha ( Acorus calamus ) and Gandira ( Coleus forskohlii ) . It has predominantly Laghu, Ruksha, Tikshna, Sukshma and Sara Guna. Laghu Guna by its property of Sattva Guna increases the Sattva part of Mana . Rukshna and Tikshna Guna help to normalize the function of Kapha Dosha thus removing the Avarana of Tamas and increasing the Sattva . Sukshmaguna helps penetrate the deeper tissue (up to the cellular level) or Shrotas for the proper action of drugs. Analysis of rasa present in the individual drugs reveals that most drugs have Tikta Rasa . Tikta Rasa being predominant in Akasha Mahabhuta and Laghu Guna increases the Sattva part of Mana and the Agnideepana function of Tikta Rasa increases the metabolism, especially of glucose in the brain and Arochakaghna property helps to treat Mandagni . Katu Rasa dominates in Agni Mahabhuta and Ruksha Guna that are responsible for Indriyauttejaka and Sanjnanasa . Madhura Rasa being predominant in Parthivamahabhuta , Snigdha, and Guruguna increases the Medhya effect Indriyaprasadhana , Brihana (improves cellular nourishment) and Sarvadhatuvardhaka helps in proper development of all tissues . Kashaya Rasa has a predominance of Vayu Mahabhuta and Laghu Guna which also increase the Sattavika property of Mana . Considering the Vipaka of all the ingredients of the study drug has Katu Vipaka . Katu Vipaka helps in accelerating overall metabolism in the body including the brain, helps in the absorption of micro and macro nutrients as per requirement in the body, and thus helps to minimize the nutrient deficiencies and stimulates all the sense organs to perceive their respective objects. Thus, it helps in alleviating ADHD symptoms.

[Find the meaning and references behind the names: Buddhi, Long, Manas, Chakra, Ama, Ras]

Omprakash Bairwa et al. Survey and intervention study in Attention Deficit Hyperactivity Disorder ISSN: 2456-3110 ORIGINAL ARTICLE September 2023 Journal of Ayurveda and Integrated Medical Sciences | September 2023 | Vol. 8 | Issue 9 72 Ingredients used in the study drug chiefly Ushna Virya. Ushna Virya by its Vata alleviating property specifies the vitiated Vata Dosha in the ADHD condition. At the same time, Ushna Virya also increases blood circulation in the brain. Most of the drugs are Kapha Vata Shamaka . Since ADHD in Ayurveda is similar to the condition Anavasthita Chitta , which is one of the Vata Nanatmaja Vyadhi , the drugs by their Vatashamaka property may help in alleviating the symptoms of ADHD. The Kaphashamaka property of drugs helps in breaking the Shrotorodha and digestion of Ama which leads to the proper function of the body as well as brain. Kaph Shamaka drugs have properties opposite to Tamasha Dosha which helps in removing the Avarana and normalizing the Tamasa Dosha so, it helps keep the equilibrium of Trigunas and maintain the proper functioning of Manas . Ingredients used in the study drug mostly have Medhya Prabhava . It has been mentioned by Nagarjuna in Rasa Vaisheshika Sutra that Medhya drugs act mainly by their “ Achintya Virya ” which is the Prabhava . This indicates that these drugs direct impact on the Medha (intellect). The exact mode of action is not very clear, but these drugs ultimately increase the cognitive capacity of the brain either by improving blood circulation or by enhancing metabolic activities. Honey has the property of dissolving Kapha Dosha, initiating the growth of healthy granulation tissues, helping in quick healing, and helping in the metabolism of fat tissue. So, it may be helpful to the growth and nourishment of brain tissues. It has a special quality known as ‘ Yogavahi’ , which helps in penetrating the deepest tissues (up to the cellular level) and enhances medicinal qualities. Since ADHD disease is concerned with the brain or Manas and Buddhi ( Ayurvedic perspective), the selection of the study drug was based on their therapeutic properties with Medhya effect. Regarding the probable mode action of Shirodhara Shirodhara is an important therapeutic measure in the Ayurvedic system of medicine in which slowly and steadily dripping medicated oil or other liquids on the forehead from a specific height of 8 cm in a fixed fashion in the form of oscillatory movements for 45 minutes daily for two weeks. The types of Murdha Taila other than Shirodhara are Shiro Abhyanga , Pichu, and ShiroBasti . This procedure induces a relaxed state of awareness that results in a dynamic psycho-somatic balance. When a constant stream of any liquid is poured over the forehead from a fixed height it results in pressure on the skin of the forehead. It stimulates pacinian receptors or mechanoreceptors present on the skin which, leads to mechanical deformation of the receptors, resulting in the change in the membrane potential of the receptor and a receptor potential is generated. This receptor potential leads to the generation of action potential, which is then passed to the cerebral cortex via the brain stem or the RAS. In this way, the information from outside reaches the cerebral cortex. The pressure input from the skin over the head is conveyed by the ophthalmic branch of the trigeminal nerve to the reticulospinal neurons via the disynaptic pathway [14] When sensory information reaches the cerebral cortex, only a small fraction cause an immediate motor response. Much of the remainder is stored for future control of motor activities and for use in thinking processes [15] Regular or continuous pressure input generates a continuous impulse to the CNS thereby continuously stimulating the CNS. Practicing this procedure regularly for 15 days may lead to long-term stimulation of the CNS. The mechanism is comparable to that of CNS stimulant medications advice to ADHD patients According to the philosophy of Yoga , the two Nadi Chakras are - Agyachakra (situated between two eyebrows) and Bhramaraguha Chakra situated at the upper part of the forehead are supposed to be stimulated by Shirodhara which interns produce their desired effect In Ayurvedic classics, the site, which the Shirodhara stimulates, is the place of Sthapnimarma (situated between two eyebrows), and Marma in Ayurveda is supposed as a junction of veins, arteries, nerves, joints, sutures, and bones. Sthapni Marma controls the sixth chakra ( Agyachakra ) and Prana Vayu . The therapeutic

[Find the meaning and references behind the names: Main]

Omprakash Bairwa et al. Survey and intervention study in Attention Deficit Hyperactivity Disorder ISSN: 2456-3110 ORIGINAL ARTICLE September 2023 Journal of Ayurveda and Integrated Medical Sciences | September 2023 | Vol. 8 | Issue 9 73 effect of medicated oil poured on the forehead may be a Tranquilizing effect, regulation of emotional and behavioral patterns and hormone secretion can also be postulated considering the effect on the hypothalamus as the hypothalamus is the main controller of endocrine secretions [16] Ultimately it can be postulated that Shirodhara may be having some potential effect on regulating the hypothalamic function. Thus, resulting in a decrease in most of the psychic and somatic disorders and making individuals perform normally and in an organized way Results of Clinical Study Table 6: Showing change in assessment criteria in both groups Grou ps Mean score N % SD of Mea n SE (±) ‘t’ Valu e ‘p’ Valu e Rem ark BT AT Diff. Co-Efficient of Division of Attention (Co. Di.) Gro up A 0.7 68 0.76 4 0.00 4 15 0.5 2 0.02 09 0.00 541 0.73 85 0.47 24 NS Gro up B 0.7 84 0.77 8 0.00 6 15 0.7 9 0.03 86 0.00 998 0.66 77 0.51 52 NS Reaction Time (R.T.) Gro up A 0.9 35 0.89 1 0.04 4 15 4.3 0.07 5 0.01 95 2.25 2 0.04 S Gro up B 1.0 13 0.95 4 0.05 9 15 4.9 5 0.15 2 0.03 94 1.50 6 0.15 NS Finger Dexterity / Motor Ability Test (FDT) For Left-Hand Gro up A 7.1 13 6.75 8 0.35 53 15 4.9 2 0.48 5 0.12 53 2.83 5 0.01 3 S Gro up B 7.2 32 6.96 1 0.27 07 15 3.7 3 0.34 6 0.08 93 3.03 0.00 9 VS Finger Dexterity / Motor Ability Test (FDT) For Right-Hand Gro up A 5.9 77 5.50 9 0.46 8 15 7.7 9 0.34 9 0.09 03 5.18 1 0.00 01 ES Gro up B 6.1 09 5.78 3 0.32 67 15 5.2 4 0.33 6 0.08 69 3.75 9 0.00 21 VS Intelligent Quotient (IQ) Gro up A 98. 06 100. 21 2.14 15 2.1 8 2.20 7 0.56 98 3.75 6 0.00 2 VS Gro up B 88. 78 91.9 73 3.19 3 15 3.5 9 5.87 9 1.51 8 2.10 4 0.05 NQS Statistically, no significant change in the Coefficient of Division of Attention was observed in Group A and Group B. Group A showed a statistically significant change in reaction time (P<0.04) and Group B showed a statistically not significant change in reaction time (P>0.05).Group B showed a statistically very significant improvement in the Finger Dexterity Test (FDT) for the Left Hand (P<0.009) and Group A showed a statistically significant improvement in FDT (P<0.01).Group A showed a statistically extremely significant improvement in the Finger Dexterity Test (FDT) for the Right Hand (P<0.0001) and Group B showed a statistically very significant improvement in FDT (P<0.002). Group A showed a statistically very significant improvement in intelligence quotient (IQ) (P<0.002) and Group B showed statistically not quite significant improvement in IQ (P<0.05). (Table No. 06 & Graph no. 01) Graph 1: Showing change in assessment criteria in both groups Table 7: Showing the total effect of therapy on core symptoms of ADHD Grou ps Mean score N % SD of Mea n SE (±) ‘t’ Valu e ‘p’ Valu e Rem ark BT AT Diff. Effect on Inattention Gro up A 1.4 66 0.8 44 0.6 22 15 42 46 0.23 09 0.07 69 8.0 84 0.00 01 Es 0 2 4 6 8 Co. Di R.T FDT-Lt Hand FDT- Rt Hand I.Q 0.52 4.3 4.92 7.79 2.18 0.92 4.95 3.73 5.24 3.59 Effect on Assessment Criteria Group A Group B

Omprakash Bairwa et al. Survey and intervention study in Attention Deficit Hyperactivity Disorder ISSN: 2456-3110 ORIGINAL ARTICLE September 2023 Journal of Ayurveda and Integrated Medical Sciences | September 2023 | Vol. 8 | Issue 9 74 Gro up B 1.6 51 0.9 55 0.6 96 15 41 81 0.20 83 0.06 94 10. 02 0.00 01 Es Effect on Hyperactivity Gro up A 1.4 11 0.7 66 0.6 44 15 45 67 0.24 45 0.09 98 6.4 6 0.00 1 Vs Gro up B 1.2 48 0.7 09 0.5 39 15 43 18 0.16 65 0.06 79 7.9 29 0.00 05 Es Effect on Impulsivity Gro up A 1.4 22 0.7 55 0.6 67 15 46 97 0.2 0.11 55 5.7 76 0.02 8 S Gro up B 1.6 22 0.9 11 0.7 11 15 43 82 0.15 44 0.08 91 7.9 78 0.01 S Statistically extremely significant improvement in symptoms of Inattention was observed in both groups A & B (P<0.0001). (Table No. 07& Graph no. 02) on comparing the intergroup differences was observed not significant for all symptoms of inattention. Statistical evaluation showed extremely significant effect of therapy on symptoms of hyperactivity was observed in group B (P<0.0005) and a very significant effect in group A (P<0.001). (Table No. 07 & Graph no. 02) On comparing the intergroup differences of changes in the score of hyperactivity showed no significance in all symptoms except H(a) - Fidgeting with hands or feet or squirming in seats. Statistical evaluation showed significant effect of therapy on symptoms of impulsivity was observed in both groups A & B (P<0.01). (Table No. 07& Graph No. 02) On comparing the intergroup differences of changes in the score of impulsivity showed no significance in all symptoms. Graph 2: Showing the effect of therapy on all symptoms of ADHD CONCLUSION The prevalence of the present survey study was 230 cases of ADHD found in 1000 subjects in the age group 6 – 12 years, out of which 26.28% were from 6 to 9 years and 18.76% were from 9 to 12 years. In the overall 230 ADHD cases, 34.35% were male, while 10.64% were female in the age group 6 – 12 years in 1000 subjects. On the Statistical Analysis tab. ELEVA on Diagnostic and Statistical Manual of Mental Disorder IV edition (DSM – IV) criteria showed extremely significant improvement in Inattention, very significant in Hyperactivity, and a significant effect on Impulsivity. Shirodhara on DSM – IV criteria showed statistically extremely significant improvement in Inattention, Hyperactivity, and a significant effect on Impulsivity. Tablet ELEVA showed statistically significant results on Reaction time (R.T.), very significant Improvement in the Finger Dexterity Test (FDT) left hand, extremely significant improvement in FDT right hand, and very significant in I. Q. Shirodhara showed very significant Improvement in both FDT -left hand and FDTright hand statistically. This work has been done by keeping in view all the cautions of bias in research, and also in the interpretation of concepts in an appropriate way. This study would serve as a guideline for research workers of the future; the author would feel his efforts have been productive. Limitations of this study ▪ In the survey study, only DSM-IV criteria for diagnosis are not sufficient. ▪ Sample size of the present study was limited. ▪ Limitation related to the accuracy of answers to Questionnaire DSM-IV. ▪ In the case of ADHD duration of treatment was short. Further suggestions for study ▪ Combination of Tab. ELEVA along with the Shirodhara procedure will be more effective in alleviating the symptoms of ADHD as compared to a single drug or procedure. 38 40 42 44 46 48 Inattention Hyperactivity Impulsivity 42.46 45.67 46.97 41.81 43.18 43.82 Effect of therapy on ADHD Symptoms Group A Group B

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Omprakash Bairwa et al. Survey and intervention study in Attention Deficit Hyperactivity Disorder ISSN: 2456-3110 ORIGINAL ARTICLE September 2023 Journal of Ayurveda and Integrated Medical Sciences | September 2023 | Vol. 8 | Issue 9 75 ▪ Treatment duration should be longer than 3 months. ▪ A study may be planned in a large sample size. ▪ A standard scale should be made for Indian children to assess ADHD REFERENCES 1 A Parthasarathy, IAP Text Book of Pediatrics 6 th edition publish by Jaypee Brothers Medical Publishers (P) Ltd. pg no. 471 2 Robert M. Kliegman [et al.], Nelson textbook of pediatrics. 19 th ed. pg no. 108 3 A Parthasarathy, IAP Textbook of Pediatrics, 4 th edition, © 2009, Indian Academy of Pediatrics pg 200 4 Shrinidhi. K. Acharya. Acharya’s Text book of Kaumarabhritya publish from Chaukhambha Orientalia, Vol 2, Page no. 1061 5 Vashisth Sunil, Therapeutic Handbook by Dr. Brijbala Vashisth (MD, ayu) and Dr. Sunil Vashisth. 6 Jyothsna Akam Venkata et. al., Prevalance of Attention Deficit Hyperactivity Disorder in Primary School Children, Indian J Psychiatry, 2013 oct-dec, 55(4) 7 Ramya HS et. al, Prevalence of Attention Deficit Hyperactivity Disorder in school going children aged between 5-12 years in Bengaluru, Curr Pediatr Res 2017: 21(2):321-326. 8 Hae Dong Woo et. al. Dietary pattern in children with Attention Deficit/ Hyperactivity Disorder, Nutrients. 2014 Apr; 6(4) 9 Berger I, et. al. Attention Deficit Hyperactivity Disorder (ADHD) and Birth Order, J Child Neurol. 2009 10 Zheng Chang et. al. Maternal age at child birth and risk for ADHD in offspring: a population-based cohort study, Int J Epidemiol. 2014 Dec; 43(6): 1815-1824 11 Biederman J. Attention deficit hyperactivity disorder. Ann Clin Psych 1991;3:9 – 22. 12 Chawla PL, Sahasi G, Sundaram KR, Mehta M. A study of prevalence and pattern of hyperactive syndrome in primary school children. Indian J Psych 1981;23:313 – 22. 13 Robert Winston et. al., The importance of early bonding on the long-term mental health and resilience of children, London J Prim Care. 2016; 8(1), PMCID: PMC 5330336. 14 Viana Di prisco et.al., Theta-rhythmically firing neurons in the anterior thalamus: implications for mnemonic functions of Papez's circuit, Neuroscience. 2001;104(3):619-25. 15 Guyton & Hall, 2006 16 Kajaria Divya et al.: An Appraisal of the Mechanism of Action of Shirodhara, Ann Ayurvedic Med. 2013; 2(3): 114-117. ******************************* How to cite this article: Omprakash Bairwa, Rakesh Kumar Nagar, Priyanka Gautam. Survey and intervention study to evaluate the efficacy of Ayurvedic formulation and Shirodhara in Attention Deficit Hyperactivity Disorder. J Ayurveda Integr Med Sci 2023;09:65-75. http://dx.doi.org/10.21760/jaims.8.9.11 Source of Support: Nil, Conflict of Interest: None declared. Copyright © 2023 The Author(s); Published by Maharshi Charaka Ayurveda Organization, Vijayapur (Regd). This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by-nc-sa/4.0), which permits unrestricted use, distribution, and perform the work and make derivative works based on it only for non-commercial purposes, provided the original work is properly cited

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