| CTRI Number |
CTRI/2024/06/068680 [Registered on: 11/06/2024] Trial Registered Prospectively |
| Last Modified On: |
08/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessing a New Treatment Approach for ADHD: Combining Herbal Syrup with Relaxation Techniques like shirodhara and shiropichu. |
|
Scientific Title of Study
|
A Single Arm Open Label Clinical Trial To Evaluate The Efficacy Of Combined Therapy - Brahmyadi Syrup With Shirodhara And Shiropichu In The Management Of Attention-Deficit/Hyperactivity Disorder |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Suman rulaniya |
| Designation |
Pg scholar |
| Affiliation |
NATIONAL INSTITUTE OF AYURVEDA JAIPUR RAJASTHAN |
| Address |
Department of kaumarbhritya National institute of ayurveda jaipur rajasthan 302002
Nagaur RAJASTHAN 302002 India |
| Phone |
7357871373 |
| Fax |
|
| Email |
sumanrulaniya97@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Rakesh nagar |
| Designation |
Associate professor department of kaumarbhritya National institute of ayurveda |
| Affiliation |
National institute of ayurveda jorawar singh gate jaipur |
| Address |
Chamber no 227 Department of kaumarbhritya national institute of ayurveda jorawar singh gate jaipur rajasthan
Jaipur RAJASTHAN 302002 India |
| Phone |
9414062099 |
| Fax |
|
| Email |
drrknagar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Vishal prajapati |
| Designation |
Assistant professor national institute of ayurveda jaipur |
| Affiliation |
National institute of ayurveda jorawar singh gate jaipur |
| Address |
Chamber no 230 Department of kaumarbhritya national institute of ayurveda jorawar singh gate jaipur rajasthan
Jaipur RAJASTHAN 302002 India |
| Phone |
8169436681 |
| Fax |
|
| Email |
Vish123go@gmail.com |
|
|
Source of Monetary or Material Support
|
| National institute of ayurveda jorawar singh gate madhav villas amber road jaipur rajasthan india 302002 |
|
|
Primary Sponsor
|
| Name |
National institute of ayurveda jaipur |
| Address |
National institute of ayurveda jorwar singh gate jaipur rajasthan 302002 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Suman rulaniya |
National institute of ayurveda |
Opd no 5 department of kaumarbhritya madhav villas Jorawar singh gate amber road jaipur Jaipur RAJASTHAN |
7357871373
Sumanrulaniya97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee national institute of ayurveda deemed university jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F902||Attention-deficit hyperactivity disorder, combined type. Ayurveda Condition: UNMADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | mUrdhatailam/ Sirastailam, मूरà¥à¤§à¤¤à¥ˆà¤²à¤®à¥/ शिरसà¥à¤¤à¥ˆà¤²à¤®à¥ | (Procedure Reference: Bhavprakash nighantu, Procedure details: Shirodhara with dashmoola sidh ksheer for 15 days ) (1) Medicine Name: Dashmoola sidh ksheer, Reference: Bhavprakash , Route: Topical, Dosage Form: Ksheerpaka, Dose: 1000(ml), Frequency: od, Duration: 15 Days | | 2 | Intervention Arm | Procedure | - | mUrdhatailam/ Sirastailam, मूरà¥à¤§à¤¤à¥ˆà¤²à¤®à¥/ शिरसà¥à¤¤à¥ˆà¤²à¤®à¥ | (Procedure Reference: Bhavprakash nighantu, Procedure details: Shiropichu with jyotishmati oil for 75 days ) (1) Medicine Name: Jyotishmati taila, Reference: Bhavprakash nighantu, Route: Topical, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Duration: 75 Days | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bramhyadi syrup, Reference: Bhaisajya ratnawali 24/5, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
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Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Children of either sex in between age group of 5 to 10 years.
Diagnosed case of ADHD.
Children with average/normal IQ level (more than 90)
Subjects satisfying DSM-5 criteria of diagnosis
|
|
| ExclusionCriteria |
| Details |
Children with any known psychiatric illness and neurological disorder.
Children with gross brain damage causing mental retardation
Children with any genetic disorder
Children with gross physical disability
Children with any associated long term or fatal disease.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in the scoring/grading of symptom of ADHD on NICHQ Vanderbilt Assessment scale. |
Every 2 week of clinical trial.
After 16 week of clinical trial completion. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in the quality of life by improvement in cognition & concentration with safe & effective treatment. |
Every 2 week of clinical trial.
After 16 week of clinical trial completion. |
|
|
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)
|
20/07/2024 |
| 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="0" Months="5" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Modern ADHD treatment have significant drawback including the potential to have a serious negative influence on a child’s entire development. Ayurveda is holding numerous ways to diagnose and manage various diseases. Although several studies have been conducted and some remain are on-going on this disease but still any specific precise management and strategy not have been established, thus much more research must be done in order to achieve this goal in future. Due to their low socioeconomic level many parents in developing nations like India unable to afford the different therapies required for ADHD. Therefore, careful research is needed to discover more affordable, accessible and palatable medications for such disease. BrahmyadiYoga is mentioned in BhaisajyaRatnavali text book, Unmadrogaadhikaar Chapter Number 24 as a Unmadaharayog.Till now, as per scholars’ knowledge there is no research work available on this drug for ADHD in children. It contains drugs like Brahmi, Vacha, Shankhpushpi, Kushmaand, Kustha which are considered as Medhya (~nootropic) drugs according to Acharya Priyavart Sharma.Active ingredients of these drugs acts on brain function which may also be beneficial in improving the symptoms of ADHD. Also, these drugs are easily available and cost effective. To improve the palatability and compliance of drug, Brahmyadiyoga will be modified as a Syrup form. Bacosides active ingredients of Brahmi responsible for improving memory related disorders, and enhance efficiency of transmission of nerve impulse there by strengthening memory and cognition.Shankhpushpi has a calming effect by regulating the body’s production of the stress hormones, adrenaline and cortisol. The bioactive components of Convolvulus pluricaulis are Sitosterol glycoside, octacosanoltetracosane, hydroxycinnamic acid, and glucose. These metabolites contribute to its nootropic and memory enhancing properties, along with its other pharmacological activities. Rhizome of Vacha has been reported to possess tranquilizing, neuroprotective, anti-cholinesterase, anticonvulsant activity.Certain research works done on Kushmanda have yielded beneficial effects on mental health. Kushmanda considers best for promotion of longevity, promotion of memory and intellect Kustha have Hypotensive and vaso relaxation effect, CNS depressant effect, immune-modulator. Shirodhara is a method whereby pouring any liquid or medicated liquid(milk/oil/buttermilk) over the forehead of the patient in the form of a regular stream from a particular height (precisely 3.14 inches (as mentioned in Dharakalpa of Sahasrayogam) in the form of oscillatory movements for 30-45 minutes. Mind and higher consciousness is affected in disease like ADHD. And these can be considered under broad term Unmada in Ayurveda. For providing an tranquilizing effect and increasing attention, Shirodhara is the well-known treatment modality. Shiropichu is procedure of applying the oil to the vertex using cotton pad impregnated with oil. It is found to be more beneficial in neuropsychiatric disorders. Because of its easy applicability along with added effect of all Moordhinitaila these considred as important procedure in ADHD. |