| CTRI Number |
CTRI/2023/04/052151 [Registered on: 28/04/2023] Trial Registered Prospectively |
| Last Modified On: |
28/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
"To evaluate the efficacy of Madhuyashti Granules and Shirodhara in
the management of Attention Deficit Hyperactivity Disorder (ADHD) in school going children." |
|
Scientific Title of Study
|
"A clinical study to evaluate the efficacy of Madhuyashti Granules and Shirodhara in
the management of Attention Deficit Hyperactivity Disorder (ADHD) in school going children." |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Minakshi |
| Designation |
Reader, Department of Kaumarbhritya |
| Affiliation |
RGGPG Ayurvedic College and Hospital |
| Address |
Room no-218, Anatomy Block, RGGPG Ayurvedic College and Hospital, Paprola, Kangra, Himachal Pradesh.
Room no-218, Anatomy Block, RGGPG Ayurvedic College and Hospital, Paprola, Kangra, Himachal Pradesh.
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418017565 |
| Fax |
|
| Email |
drminakshi2050@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Minakshi |
| Designation |
Reader, Department of Kaumarbhritya |
| Affiliation |
RGGPG Ayurvedic College and Hospital |
| Address |
Room no-218, Anatomy Block, RGGPG Ayurvedic College and Hospital, Paprola, Kangra, Himachal Pradesh.
RGGPG Ayurvedic College and Hospital, Paprola, Kangra, Himachal Pradesh.
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418017565 |
| Fax |
|
| Email |
drminakshi2050@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Zenia Dharani |
| Designation |
PG Scholar, Department of Kaumarbhritya |
| Affiliation |
RGGPG Ayurvedic College and Hospital |
| Address |
RGGPG Ayurvedic College and Hospital, Paprola, Kangra, Himachal Pradesh.
RGGPG Ayurvedic College and Hospital, Paprola, Kangra, Himachal Pradesh.
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
6238516037 |
| Fax |
|
| Email |
zeniadharani7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Govt. Ayurvedic Pharmacy Paprola, Distt. Kangra, Herbal garden and Herbarium, Research Institute in ISM, Jogindernagar, Distt. Mandi |
|
|
Primary Sponsor
|
| Name |
RGGPG Ayurvedic College |
| Address |
RGGPG Ayurvedic College and Hospital, Paprola, Kangra 176115 |
| 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 Minakshi |
RGGPG Ayurvedic College, Paprola |
Room no-218, Anatomy Block, RGGPG Ayurvedic College and Hospital, Paprola, Kangra, Himachal Pradesh.
Kangra
HIMACHAL PRADESH |
9418017565
drminakshi2050@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee (Human) |
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: UNMADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Madhuyashti Granules, Reference: Charaka samhita, Chikitsa sthana, 1/3/30-31, Route: Oral, Dosage Form: Khanda /Granules, Dose: 80(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Milk), Additional Information: - | | 2 | Intervention Arm | Procedure | - | takradhArA | (Procedure Reference: , Procedure details: Shirodhara is a method of pouring cow’s milk or oil over forehead of patients in the form of a
regular stream from a specific height of about 3.14 inches as mentioned in Ayurveda classics in fixed
oscillatory movement for 45 minutes per day for two weeks)
|
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1. Individual between age group of 6 to 15 years of
both genders having fulfilled DSM V criteria.
2. Children with IQ > 80.
3. Parents of patient willing to participate in the
trial.
|
|
| ExclusionCriteria |
| Details |
1. Individuals below 6 years & above 15 years of
age.
2. Mental disorders like conduct disorder,
anxiety, depressive disorders, obsessive
disorders & compulsive disorder.
3. Children with schizophrenia.
4. Children having medical illness like hearing
loss, hypothyroidism, genetic disorder &
seizures.
5. Children having congenital deformity or
Muscular dystrophy. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fulfillment of objective criteria. |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out the prevalence of ADHD. |
45 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 1/ Phase 2 |
|
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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
I would like to publish my research trial after completion as soon as possible. A total of 40 subjects will be studied in two groups. 20 patients will be given Madhuyashti granules and rest 20 will be given both Madhuyashti granules as well as Shirodhara. The outcome will be analyzed with appropriate statistical tools. |