| CTRI Number |
CTRI/2025/07/090561 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
Exploring Brahmi Ghrita Nasya for Cognitive Impairment Following ECT in Depression Patients |
|
Scientific Title of Study
|
A Randomized Controlled Study of Brahmi Ghrita Nasya (BGN) for the Amelioration of Cognitive Impairment Following Electroconvulsive Therapy in Patients with Depression. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vandana PV |
| Designation |
Junior Resident |
| Affiliation |
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES BANGLORE |
| Address |
Department of Integrative Medicine National Institute of Mental Health and Neuro Sciences Banglore Karnataka
National Institute of Mental Health and Neuro Sciences Banglore Karnataka
Bangalore
KARNATAKA
560029
India |
| Phone |
09562573623 |
| Fax |
|
| Email |
vandanathamban@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kishore Kumar R |
| Designation |
Professor HOD |
| Affiliation |
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES BANGLORE |
| Address |
Department of Integrative Medicine, National Institute of Mental Health and Neurosciences Bengaluru Karnataka
Bangalore
KARNATAKA
560029
India |
| Phone |
9845829174 |
| Fax |
|
| Email |
ayurkishore@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vandana PV |
| Designation |
Junior Resident |
| Affiliation |
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES BANGLORE |
| Address |
Department of Integrative Medicine National Institute of Mental Health and Neurosciences Bengaluru Karnataka
Bangalore
KARNATAKA
560029
India |
| Phone |
09562573623 |
| Fax |
|
| Email |
vandanathamban@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Mental Health and Neurosciences Bengaluru Karnataka |
|
|
Primary Sponsor
|
| Name |
Dr Vandana PV |
| Address |
Department of Integrative Medicine National Institute of Mental Health and Neurosciences Bengaluru Karnataka |
| Type of Sponsor |
Other [STUDENT] |
|
|
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 Vandana PV |
National Institute of Mental Health and Neurosciences Bengaluru Karnataka |
Department of Integrative Medicine National Institute of Mental Health and Neurosciences Bengaluru Karnataka
Bangalore
KARNATAKA |
9562573623
vandanathamban@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Ethics Committee For Research in AYUSH and Integrative Medicine |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G||Mental Health. Ayurveda Condition: UNMADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Ashtanga Hridaya, Procedure details: Purvakarma-Abhyanga (massage) should be done on scalp, forehead,face and neck for 3 to 5 minutes by medicated oil . Swedana may be given for elimination of Doshas
and liquification of Doshas.
Pradhana karma-Patient should lie down in supine position with ease
on Nasya table. The therapist should raise the tip of the patient’s nose
with his left thumb and with the right hand 5-6 drops of medicated ghee (brahmi ghrita)should be droppedin both the nostrils alternately .
Pashat karma-After administration of medication through Nasal
passage patient should lie supine (Uttana) for about 2
minute time interval & ask him to count numbers upto
100. After an administration of Nasya feets, shoulders,
palms and ears should be massaged. Patient should spit out the medicine which have come into the oropharynx. )
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed patients with depression who are indicated for bifrontal electroconvulsive therapy (ECT) and are undergoing a minimum of three ECT sessions
Patients who are cooperative for baseline cognitive assessment
Age between 18 and 65 years |
|
| ExclusionCriteria |
| Details |
Uncontrolled diabetes mellitus or hypertension
Age below 18 years or above 65 years
Pregnant women
Presence of any severe physical illness
Intellectual disability disorder
Patients undergoing bitemporal ECT or unilateral ECT
Pre-existing cognitive disorder
Neurological illnesses
Substance use disorder (excluding nicotine dependence)
Vitamin B12 deficiency or thyroid deficiency disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual and autobiographical memories were tested using subsets of the B4ECT ReCoDe. |
Base line, after3 rd ECT, after 6th ECT, after last ECT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Verbal memory and working memory were assessed using the Rey Auditory Verbal Learning Test (RAVLT), Digit Span, and Spatial Span tests.
Verbal fluency was evaluated using the Controlled Oral Word Association Test (COWAT).
Adverse effects were measured by UKU scale. |
Baseline, after 3rd ECT, after 6th ECT, after last ECT. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
24/07/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Depression is the most common psychiatric disorder in world population and ECT is considered as most effective treatment for severe , psychotic, or treatment resistant depression .Studies suggested that ECT is associated with acute deficits in cognitive domains .There is a paucity of literature to suggest efficacy of intervention on cognitive impairment following ECT. Study found that bacopa monnieri can improve higher order cognitive process and panchakarma therapy like nasya is useful in the treatment of dementia. Hence the study aims to evaluate efficacy of brahmi ghrita nasya in ameliorating ECT induced cognitive impairment in depression. |