| CTRI Number |
CTRI/2025/08/093325 [Registered on: 20/08/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on Ayurvedic memory enhancing herbs in the management of ADHD w.s.r. to Vataja Unmada |
|
Scientific Title of Study
|
Clinical Evaluation of Medhya Rasayana drugs in the management of Attention Deficit Hyperactivity Disorder (ADHD) w.s.r. Vataja Unmada |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vaishnavi Deepak Raghorte |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurvedic College and Hospital, Patna, Bihar - 800003, India |
| Address |
Government Ayurvedic College, Near Buddha Murti, Kadamkuan, Patna, Bihar - 800003, India.
Patna
BIHAR
800003
India |
| Phone |
9403765986 |
| Fax |
|
| Email |
vaishnavi.raghorte@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arvind Chaurasia |
| Designation |
Professor & HOD Department of Kaumarbhritya |
| Affiliation |
Department of Kaumarbhritya, Government Ayurvedic College and Hospital, Kadamkuan, Patna |
| Address |
Department of Kaumarbhritya, 2nd floor, Government Ayurved College, Near Buddha Murti Kadamkuan Patna Bihar - 800003, India.
Patna
BIHAR
800003
India |
| Phone |
9835255180 |
| Fax |
|
| Email |
arvindschaurasia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arvind Chaurasia |
| Designation |
Professor and Head of department, Department of Kaumarbhritya |
| Affiliation |
Department of Kaumarbhritya, Government Ayurvedic College and Hospital, Kadamkuan, Patna |
| Address |
Department of Kaumarbhritya, 2nd floor,Government Ayurved College, Near Buddha Murti Kadamkuan Patna Bihar 800003, India.
Patna
BIHAR
800003
India |
| Phone |
9835255180 |
| Fax |
|
| Email |
arvindschaurasia@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College and Hospital, Kadamkuan, Patna,Bihar - 800003, India. |
|
|
Primary Sponsor
|
| Name |
Government Ayurvedic College and Hospital, Patna |
| Address |
Government Ayurvedic College and Hospital, Near Buddha Murti, Kadamkuan, Patna, Bihar- 800003, India. |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Vaishnavi Deepak Raghorte |
Government Ayurvedic College and Hospital, Patna |
Department of Kaumarbhritya, Government Ayurvedic College and Hospital, Buddha Murti, Kadamkuan Patna , Bihar -800003, India
Near Buddh Murti, Kadamkuan , Patna, Bihar -800003, India
Patna
BIHAR |
9403765986
vaishnavi.raghorte@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F59||Unspecified behavioral syndromes associated with physiological disturbances and physical factors. Ayurveda Condition: UNMADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Medhya Rasayana, Reference: charak samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -honey), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children of age group 5-12 years, irrespective of sex, ethnicity, socio- economic
status.
Children satisfying DSM V (Diagnostic & Statistical Manual of Mental
Disorders, Fifth Edition)3 criteria.
Mild to moderate symptomatic patients.
Already diagnosed cases of ADHD. |
|
| ExclusionCriteria |
| Details |
Children below 5 years and above 12 years will be excluded from study.
Children with seizures and recurrent upper respiratory infections will be
excluded from the trial due to potential drug interactions & possibility of
infections.
Children with medical illness like hearing loss, hypothyroidism, genetic
disorder, co-morbid conditions such as cerebral palsy, mental retardation.
Children having congenital deformity or Muscular dystrophy and other chronic
neurological & metabolic disorders will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the symptoms of patients in the following domains of Hyperactivity, impulsivity and attention deficit. |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to assess the efficacy of trial medicine on disease |
90 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
22/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Attention Deficit Hyperactivity Disorder (ADHD) is a common neurobehavioral disorder in children, characterized by inattention, hyperactivity, and impulsivity, which affects learning behavior and social interaction. While modern diagnostic criteria like DSM V help identify the condition Ayurveda does not directly mention ADHD but associates its symptoms with Vataja Unmada, a mental disorder caused by aggravated Vata dosha, showing signs like mental confusion, memory loss, abnormal behavior, and instability of mind. Conventional treatments for ADHD often involve stimulant medications that may lead to serious side effects such as cardiovascular issues. In contrast, Ayurveda recommends Medhya Rasayana—herbs like Mandukparni, Yashtimadhu, Shankhapushpi, Guduchi, and Jatamamsi—for improving concentration, cognition, and mental balance by correcting imbalances in Rajas and Tamas gunas. These herbs are believed to enhance brain function safely and holistically. Given the increasing prevalence of ADHD and limitations of current treatments, this study aims to clinically evaluate the effectiveness of Medhya Rasayana drugs in managing ADHD symptoms through Ayurvedic principles.anger) and instantaneously distorts intellect and memory. Because of all this, the following sign and symptoms are observed: laughing, singing, dancing, smiling, moving limbs of body, speaking, and weeping in inappropriate place. Along with this general Unmada symptoms like dhristiadhirta (unsteadiness of vision), dhee vibhram (intellectual confusion), satva pariplava (the fickleness of mind), paryakula (impatience may also be seen).The Charak Samhita also refers the following: vitiation of Dhee (rational thinking), Dhriti (intellect/ retaining power of the mind), Smriti(memory). This causes “Asatmyindriyarthsanyoga” abnormal conduct leading to “improper contact of the senses with objectives.” This results in inattention, over activity, and impulsivity, characteristic of ADHD. According to Acharya Kashyap, a child with Unmada shows the symptoms like Vaichityam (instability of mind), Pralapam (incoherent speech) and Arati (inatention). Medhya Rasayana is mentioned in Ayurvedic texts for improving the brain function which are used as Shaman chikitsa for ADHD type of disorder, because Medhya drugs improve concentration, cognition and coordination capacity of brain. Medhya Rasayana is a group of medicinal plants (mentioned by Acharya Charak) that can be used singly or in combinations. They are Mandukparni (Centella asiatica Linn.) Yashtimadhu (Glycirrhiza glabra Linn.), Guduci(Tinospora cordifolia (Wild) Miers ) and Shankhapushpi (Convolvus pleuricaulis Chois), specially mentioned with a wide range of applications on different systems. Other beneficial drug used with similar aim is Jatamamsi (Nardostachys jatamamsi). The Medhya effect of drugs can be considered as Prabhava janya (unthinkable and unimaginable). Medhya drugs also act on Manasika bhavas (faculties of mind) by relieving anxiety, stress etc. |