| CTRI Number |
CTRI/2021/02/031220 [Registered on: 11/02/2021] Trial Registered Prospectively |
| Last Modified On: |
29/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on Ayu Hraas Krama to access the Medhya effect of Guduchi Swarasa in healthy subjects. |
|
Scientific Title of Study
|
A Conceptual study on Ayu Hraas Krama of Sharangdhar Samhita and a three arm clinical study to assess the Medhya effect of Guduchi Swarasa in healthy subjects of different age groups |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kalapna yadav |
| Designation |
MD Scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Room no 720 Dept of Samhita and Siddhant Academic block All India Institute of Ayurveda Mathura Road Gautam Puri Sarita Vihar New Delhi 110076
All India Institute of Ayurveda Mathura Road Gautam Puri Sarita Vihar New Delhi 110076
South
DELHI
110076
India |
| Phone |
9116748767 |
| Fax |
|
| Email |
kalpirao131313@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh Vyas |
| Designation |
HOD and Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Room no 716 Dept of Samhita and Siddhant Academic block All India Institute of Ayurveda Mathura Road Gautam Puri Sarita Vihar New Delhi 110076
All India Institute of Ayurveda Mathura Road Gautam Puri Sarita Vihar New Delhi 110076
South
DELHI
110076
India |
| Phone |
8849802005 |
| Fax |
|
| Email |
drmaheshkvyas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pankaj Pathak |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Room no 719 Dept of Samhita and Siddhant Academic block All India Institute of Ayurveda Mathura Road Gautam Puri Sarita Vihar New Delhi 110076
All India Institute of Ayurveda Mathura Road Gautam Puri Sarita Vihar New Delhi 110076
South
DELHI
110076
India |
| Phone |
9737491078 |
| Fax |
|
| Email |
pankajayur07@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
All India Institute of Ayurveda Mathura Road Gautam Puri Sarita Vihar New Delhi 110076 |
| 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 Kalpana Yadav |
All India Institute of Ayurveda |
Opd no. 7 All India Institute of Ayurveda Mathura Road Gautam Puri Sarita Vihar New Delhi 110076
South
DELHI |
9116748767
kalpirao131313@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 |
Healthy Human Volunteers of 21-50 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Guduchi Swarasa |
25 ml of Guduchi Juice will be given once in morning empty stomach for 60 days |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy subjects of three age group- 1. 21-30 years 2. 31-40 years 3. 41-50 years
Healthy subjects irrespective to their caste, religion, gender will be taken.
2. Prior informed written consent will be taken. |
|
| ExclusionCriteria |
| Details |
Healthy subjects with following condition will be excluded
1. Congenital diseases.
2. Hereditary diseases
3. Other co- morbidities. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To explore the Effect of Medhya Rasayana [Guduchi Swarasa] on IQ levels in different
age groups of healthy subjects |
IQ level will be checked after 90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effect on quality of life |
90 days |
|
|
Target Sample Size
|
Total Sample Size="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
21/12/2021 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
the study will be publised in a reputed journal |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
in this study there is assessment of Medhya effect of Guduchi swarasa (Medhya Rasayana) in 3 different age group (1. 21-30 2. 31-40 3.41-50) of healthy individuals. in this research Guduchi swarasa (stem and leaves) will be given every morning approximately at 6:00 AM empty stomach for 60 days. And there is a scale called Wechsler adult intelligence scale, this scale includes some questions which will decide the IQ of a person. before intervention of Guduchi swarasa and after intervention assessment of IQ of specific person will be done through this scale. Before taking Guduchi swarasa some tests including CBC, HB, BLOOD PRESSURE, blood sugar level measurement will be done to exclude any pathology. |