| CTRI Number |
CTRI/2023/04/051683 [Registered on: 17/04/2023] Trial Registered Prospectively |
| Last Modified On: |
08/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Ayurvedic treatment protocol in the management of Attention-Deficit Hyperactivity Disorder (ADHD) |
|
Scientific Title of Study
|
Efficacy of Ayurvedic treatment protocol in the management of Attention-Deficit Hyperactivity Disorder (ADHD) – An open labelled single arm clinical trial |
| Trial Acronym |
ADHD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sudesh Pardhi |
| Designation |
MD Scholar |
| Affiliation |
ITRA Jamnagar |
| Address |
PG Boys Hostel, Room no. 71, ITRA, opp. city B division police station, PN marg, Jamnagar, Gujarat
OPD Building, OPD no. 15, ITRA, opp. city B division police station, PN marg, Jamnagar, Gujarat
Jamnagar
GUJARAT
361008
India |
| Phone |
8208708274 |
| Fax |
|
| Email |
sudeshpardhi99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Apexa Vyas |
| Designation |
Reader |
| Affiliation |
ITRA jamnagar |
| Address |
Institute Building, Fifth floor, room no. 530, ITRA, opp. city B division police station, PN marg, Jamnagar, Gujarat
Jamnagar
GUJARAT
361008
India |
| Phone |
8767313802 |
| Fax |
|
| Email |
dr_apexa_r@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Apexa Vyas |
| Designation |
Reader |
| Affiliation |
ITRA jamnagar |
| Address |
Institute Building, Fifth floor, room no. 530, ITRA, opp. city B division police station, PN marg, Jamnagar, Gujarat
Jamnagar
GUJARAT
361008
India |
| Phone |
8767313802 |
| Fax |
|
| Email |
dr_apexa_r@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Institute of Teaching and Research in Ayurveda |
|
|
Primary Sponsor
|
| Name |
Institute of Teaching and Research in Ayurveda, 361008 |
| Address |
ITRA opposite city B division police station PN marg Jamnagar Gujarat |
| 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 |
| Sudesh Pardhi |
Institute of Teaching and Research in Ayurveda |
ITRA, opp. city B division police station, PN marg, Jamnagar, Gujarat
Jamnagar
GUJARAT |
8208708274
sudeshpardhi99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe of Institute of Teaching and Research in Ayurveda Jamnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F909||Attention-deficit hyperactivity disorder, unspecified type. Ayurveda Condition: VATAJA-UNMADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Hingwashtaka Churna, Reference: A.H./Ch. 14/35, Route: Oral, Dosage Form: Churna/ Powder, Dose: 8.25(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: -ghrita), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Panchagavya ghrita, Reference: AH Uttarastana chapter 7 shloka 18, Route: Oral, Dosage Form: Ghrita, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - | | 3 | Intervention Arm | Procedure | - | pratimarSaH, पà¥à¤°à¤¤à¤¿à¤®à¤°à¥à¤¶ | (Procedure Reference: Astanga Hridya Uttar Sthana 7 verse 18 , Procedure details: Pratimarsha nasya
Duration 2 drops in each nostrils for 21 days)
(1) Medicine Name: Panchagavya ghrita, Reference: Astanga Hridya Uttar Sthana 7 verse 18, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: od, Duration: 21 Days | | 4 | Intervention Arm | Procedure | - | SiraHsekaH, शिरःसेकः | (Procedure Reference: AH Sutra sthana chapter 2 verse 26, Procedure details: Shiro Dhara is a method of pouring Balakwatha over the forehead of patients in the form of a regular stream from a height of about 4-5 inches in a fixed oscillatory movement Purva karma Closing the eyes of the patient with cotton and should be tied with proper bandages Earplug of cotton should be applied Pradhan karma Patient should lie in the supine position on the Droni Eyes should be covered with cotton and gauze its height should be fixed such that Balakwatha should fall from a height)
(1) Medicine Name: Bala, Reference: Bhav Prakash Nighantu Guduchyadi Varga Shloka 144, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 4000(ml), Frequency: od, Duration: 7 Days |
|
|
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Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Children between the age group of 6 to 12 years irrespective of their sex, religion, caste, etc. having fulfill DSM-V criteria. |
|
| ExclusionCriteria |
| Details |
1. Children below 6 years & above 12 years of age.
2. Mental disorders like conduct disorder, anxiety, depressive disorders, obsessive disorders & compulsive disorder.
3. Children with schizophrenia.
4. Children having a medical illness like hearing loss, hypothyroidism, genetic disorder & seizure disorder.
5. Children having congenital deformity or Muscular dystrophy.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. NCHQ FOR ADHD (BT and AT)
2. IQ assessment by Draw a Person test (BT and AT)
|
33 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Improvement in school performance and health status of the children |
33 days |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 3 |
|
Date of First Enrollment (India)
|
01/05/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Efficacy of Ayurvedic treatment protocol in the management of Attention-Deficit Hyperactivity Disorder (ADHD) – An open labelled single arm clinical trial • Introduction: - ADHD characterized by inattention, including increased distractibility & difficulty sustaining attention; poor impulse control and decreased self-inhibitory capacity; and motor over activity and motor restlessness. Above characteristics of ADHD point towards imbalance of Shareerika (specifically Vata) and Manasika (specifically Raja) Dosha. In modern practice ADHD treatment is based on psychiatric counselling and psycho stimulant medication which have safety concerns. Ayurveda has mentioned Medhya Rasayana drugs that enhance concentration, retention abilities of brain. Rasayana Medhya drugs may be effective in ADHD as the disorder affects the Manasik Bhavas in a child influencing both Shareerika and Manasika Dosha. Considering the same, we hypothesize that they may be effective in ADHD. As the therapy requires to calm the child and increase span of concentration. • Rationale for selection of the topic: - According to World Health Organization, in 2020, the number of people living with mental disorders rose significantly because of the COVID-19 pandemic. Initial estimates show a 26% and 28% increase respectively for anxiety and major depressive disorders in just one year These Children constitute about 40% of our population and in Indian studies the reported rate of psychopathology among children is 5-15%. A time has thus arrived for theory and practice of child psychology, child psychiatry and paediatric behavioural medicine to be adapted to ground realities and priorities in India. • Aim and Objectives: - To evaluate the efficacy of Ayurvedic treatment protocol in Attention-Deficit Hyperactivity Disorder (ADHD) in children • Materials and Methods: - 20 desired Patients of ADHD will be volunteers which are between age group of 6 to 12 year and fulfils the Inclusion and Exclusion criteria. Volunteers will undergo the treatment protocol which consists of Deepana Pachana by Hingwashtaka churna, Shirodhara by Balakwatha, Shamana Aushadha And Pratimarsha Nasya with Panchagavyaghrita • Results and Discussion: Data generated during the above study will be present in a Systemic manner as shall be analysed statistically. Where the important points of the Conceptual study, Analytical study, Pharmacological study will be discussed. Side Effects: These drugs have no known unwanted effects. Adverse Drug Reactions if any are observed will be reported to the Pharmacovigilance cell of I.T.R.A., Jamnagar.
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