| CTRI Number |
CTRI/2021/09/036950 [Registered on: 29/09/2021] Trial Registered Prospectively |
| Last Modified On: |
28/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive
Screening |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative effectiveness of Jyotishmati and Yastimadhu granules in improving IQ and memory in school-aged children with various prakriti- A randomised, double blind clinical trial |
|
Scientific Title of Study
|
Evaluation of comparative efficacy of Jyotishmati and Yastimadhu granules in enhancing IQ and memory in school going children having different prakriti A double blind randomized clinical trail |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ibamedabha Japang |
| Designation |
PG scholar |
| Affiliation |
PG Student |
| Address |
Mahatma Gandhi Ayurved College Hospital And Research Centre Salod Wardha
Mahatma Gandhi Ayurved College Hospital And Research Centre Salod Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8073804823 |
| Fax |
|
| Email |
ibjapang@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Renu Rathi |
| Designation |
Professor |
| Affiliation |
Professor and Head Department of Kaumarbhritya MGACH & RC |
| Address |
Mahatma Gandhi Ayurveda College Hospital And Research Center salod Wardha
Aditya Resedency Yavatmal Road Sawangi meghe Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9373703816 |
| Fax |
|
| Email |
renu.rathi@dmimsu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Ibamedabha Japang |
| Designation |
PG scholar |
| Affiliation |
PG Student Department of Kumarbhritya |
| Address |
Mahatma Gandhi Ayurved College Hospital And Research Center salod Wardha
Near Mahatma Gandhi Ayurveda college Neri, Punarvasan Salod (H) Wardha 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
08073804823 |
| Fax |
|
| Email |
ibjapang@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurveda College Hospital And Research Centre salod Wardha |
|
|
Primary Sponsor
|
| Name |
Ibamedabha Japang |
| Address |
Mahatma Gandhi Ayurveda College Hospital And Research Centre salod Wardha |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Mahatma Gandhi Ayurveda College Hospital And Research Centre |
Mahatma Gandhi Ayurveda College Hospital And Research Centre salod Wardha 442001 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ibamedabha Japang |
DMIMS Deemed to be University |
Department of Kaumarbhritya Mahatma Gandhi Ayurveda Hospital And Research Centre salod, Wardha 442001
Wardha
MAHARASHTRA |
8073804823
ibjapang@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Children of dominant vataj, pittaj, kaphaj prakriti. |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Yastimadhu, Reference: Charaka, sushrut, Vagbhat, Route: Oral, Dosage Form: Khanda /Granules, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -Milk), Additional Information: | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: jyotishmati, Reference: raj nigantu, Route: Oral, Dosage Form: Khanda /Granules, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -milk), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
children whose parents are willing to participate and signed the informed consent.
children of dominant vataj, pittaj, kaphaj. |
|
| ExclusionCriteria |
| Details |
children with subnormal intelligence or having diagnosed mental illness.
children suffering any acute or chronic illness and or taking medicine. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of jyotishmati on IQ and memory with different prakriti types |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Yastimadhu on IQ and memory with different prakriti types |
2 months |
|
|
Target Sample Size
|
Total Sample Size="65"
Sample Size from India="60"
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)
|
11/10/2021 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The
study will be randomized, standard controlled double blind , parallel group
clinical study on healthy volunteer children between 8-13 years. in Group 1 will be given Jyotishmati granules
in dose as per age in two divided dose with milk. While Goup 2 will be given Yastimadhu granules in dose as per age
in two divided dose. Granules will be
made of study drug i.e Yastimadhu and
Jyotishmati, With use of jaggery and
cow ghee. The drug will be given continuously for 60 days.
|