| CTRI Number |
CTRI/2015/08/006086 [Registered on: 11/08/2015] Trial Registered Retrospectively |
| Last Modified On: |
07/08/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [nootropic effect] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative evaluation of nasal (Nasya Karma) and oral administration of Brahmi Ghrita in healthy volunteers to evaluate the
Memory boosting effect. |
|
Scientific Title of Study
|
A comparative clinico-experimental evaluation of nasal (Nasya Karma) and oral administration of Brahmi Ghrita |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chetan M Gulhane |
| Designation |
MD PhD scholar |
| Affiliation |
IPGT and RA GAU jamnagar |
| Address |
Department of Panchakarma Institute for Post Graduate Teaching &
Research in Ayurveda Gujarat Ayurved University jamnagar Gujarat
Jamnagar
GUJARAT
361008
India |
| Phone |
9725519405 |
| Fax |
|
| Email |
drchetanayu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anup B Thakar |
| Designation |
Associate Professor & I/C Head dept. of Panchakarma |
| Affiliation |
IPGT and RA GAU jamnagar |
| Address |
Department of Panchakarma, I.P.G.T. & R.A., Gujarat Ayurved University, Jamnagar-361008
Jamnagar
GUJARAT
361008
India |
| Phone |
9427776660 |
| Fax |
|
| Email |
anup_thakar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Chetan M Gulhane |
| Designation |
MD PhD |
| Affiliation |
IPGT and RA GAU jamnagar |
| Address |
Department of Panchakarma Institute for Post Graduate Teaching &
Research in Ayurveda Gujarat Ayurved University jamnagar Gujarat
GUJARAT
361008
India |
| Phone |
9725519405 |
| Fax |
|
| Email |
drchetanayu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for post graduate teaching and research in Ayurveda, Gujarat Ayurved University, Jamnagar |
|
|
Primary Sponsor
|
| Name |
Institute for post graduate teaching and research in Ayurveda Gujarat Ayurved University Jamnagar |
| Address |
Institute for post graduate teaching and research in Ayurveda, Gujarat Ayurved University, Jamnagar |
| 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 Chetan M Gulhane |
OPD and IPD of IPGTRA |
Institute for post
graduate teaching and
research in Ayurveda
Gujarat Ayurved
University Jamnagar
Jamnagar
GUJARAT |
9725519405
drchetanayu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGT & RA, Ethics Committee. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
to improve memory power |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brahmi Ghrita Nasya |
The dose of Nasya - 16 Bindu
(8 ml) in each nostril (total 32
Bindu),three sitting of 7 days,
interval of 7 days |
| Intervention |
Brahmi Ghrita Shamana
Snehapana |
Dose 16 ml Early in the morning
(Rasayana kala),three sitting of
7 days, interval of 7 days
(total-35 days) Anupana-
Lukewarm water (Ushnodaka) |
| Comparator Agent |
Go-Ghrita Nasya |
The dose of Nasya - 16 Bindu
(8 ml) in each nostril (total 32
Bindu),three sitting of 7 days,
interval of 7 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Healthy Volunteers between age group of 20 years to 60 years |
|
| ExclusionCriteria |
| Details |
1)Healthy Volunteer having age less than 20 years & above 60 years.
2)Classical Nasya Karma Ayogya and Abhyantar Snehapana Ayogya
volunteers.
3) Diabetes, any cardiovascular diseases, renal diseases or any other disease effecting multiple body systems and pregnant women etc. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
memory enhancer and cognitive enhancer in
healthy volunteers |
35 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Analysis of effects of Brahmi Ghrita when
administrated nasally (Nasya) and orally with same dose |
35 Days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
06/08/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study was a randomized, open clinico-experimental trial. This study aims to evaluate the efficacy of nasal (Nasya) and oral administration of Brahmi Ghrita (Bacopa monnieri) as memory enhancer and cognitive enhancer in healthy volunteers, In this study 101 Healthy volunteers attending OPD and IPD of Panchakarma department IPGT and RA, GAU Jamnagar was selected and randomly divided into 3 groups. In Group A (classical Brahmi Ghrita nasally) 33 volunteers, in group B (Brahmi Ghrita internally) 34 volunteers and in Group C (cow ghee nasally) 33 healthy volunteers were completed the treatment and 1 healthy volunteers left before completion of treatment. The dose of Nasal and oral administration was 16 ml in the morning for 35 days. Brahmi Ghrita contain Bacopa monnieri and cow ghee. Assessment was done by Manas Pariksha Bhava (metal examination) and PGI memory Scale before and after treatment.All groups were effective in memory enhancement in the healthy volunteers. Comparatively, Brahmi Ghrita Nasya(nasal administration) is more effective than other therapies under trial. In the PGI memory scale, statistically significant improvement was found in parameters like Attention and Concentration, Delayed recall, immediate Recall, Retention for Dissimilar pairs and Visual retention. In Brahmi Ghrita Nasya when compared to Cow ghee Nasya, In some parameters like Delayed recall, Visual retention and Recognition, significantly higher results in Brahmi Ghrita Nasya (nasal administration)as compared to Brahmi Ghrita Snehapana (oral administration), proves the superiority of Nasyakarma (nasal admiration of drug ) over Snehapana(oral admiration of ghee) in memory enhancing. |