| CTRI Number |
CTRI/2024/11/076837 [Registered on: 14/11/2024] Trial Registered Prospectively |
| Last Modified On: |
06/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study to evaluate the effect of Ayurveda medication; Brahmi Ghrita on memory loss. |
|
Scientific Title of Study
|
Effect of Brahmi ghrita on cognitive, neurodegenerative and neurotrophic parameters in Mild Cognitive Impairment – A Double-blind Randomized Placebo-controlled Trial |
| 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 Santhosh C |
| Designation |
PhD Scholar/ Senior Research fellow |
| Affiliation |
National Institute of Mental Health and Neurosciences, Bengaluru |
| Address |
Dept of Integrative Medicine
National Institute of Mental Health and Neurosciences, Bengaluru
Bangalore
KARNATAKA
560011
India |
| Phone |
9400220351 |
| Fax |
|
| Email |
santhosh.senan3330@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kishore Kumar R |
| Designation |
Professor and Head |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Dept. of Integrative Medicine, National Institute of mental Health and Neurosciences, Bangalore, Karnataka.
Bangalore
KARNATAKA
India
Bangalore
KARNATAKA
560029
India |
| Phone |
9845829174 |
| Fax |
|
| Email |
ayurkishore@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kishore Kumar R |
| Designation |
Professor and Head |
| Affiliation |
National Institute of mental Health and Neurosciences |
| Address |
Dept. of Integrative Medicine, National Institute of mental Health and Neurosciences, Bangalore, Karnataka.
Bangalore
KARNATAKA
India
Bangalore
KARNATAKA
560029
India |
| Phone |
9845829174 |
| Fax |
|
| Email |
ayurkishore@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Ministry of AYUSH, Government of India, AYUSH Bhavan, GPO Complex, B Block, Barapullah road, INA colony, New Delhi,110023 |
|
|
Primary Sponsor
|
| Name |
Ministry of AYUSH, Government of India |
| Address |
AYUSH Bhavan, GPO Complex, B Block, Barapullah Rd, INA
Colony, New Delhi, Delhi 110023 |
| Type of Sponsor |
Government funding agency |
|
|
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 Santhosh C |
National Institute of Mental Health and Neurosciences |
Dept. of Integrative
Medicine, National Institute of mental Health and Neurosciences
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
9400220351
santhosh.senan3330@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:G300||Alzheimers disease with early onset. Ayurveda Condition: BUDDHISAMMOHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Brahmi Ghrita, Reference: API, Route: Oral, Dosage Form: Ghrita, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -warm water), Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: plain cow ghee, Reference: NA, Route: Oral, Dosage Form: Ghrita, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects with Amnestic single or multi-domain mild cognitive impairment aged 55 years and above irrespective of gender.
2. Subjects with concern regarding a change in cognition, from the patient, an informant, or a skilled clinician.
3. Subjects with impairment in one or more cognitive domains relative to a person’s age and educational attainment.
4. Subjects who is independent in functional abilities (although they may take more time or be performed less efficiently)
|
|
| ExclusionCriteria |
| Details |
1. Patients with diagnosis of a major cognitive or neurodegenerative disorder.
2. Patients with history of head injury or CVA.
3. Patients diagnosed with severe mental disorders.
4. Patients with history of alcohol or substance abuse within the past 2 years.
5. Patients with uncontrolled diabetes, hypertension, dyslipidemia, or thyroid disease.
6. Patients with visual or hearing impairment impeding comprehension
7. Patients who are Participating in another intervention trial
8. Those who are undergoing treatment for mci under a professionally qualified ayurveda or yoga expert.
9. Those who are on regular herbal supplements for cognitive enhancement.
10. Those who are practicing yoga and meditation regularly in the last 6 months
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary - Change in attention, Memory and executive functions (will be assessed using NIMHANS Neuropsychological battery for elderly )
|
Baseline (0th day) and after 12 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary - Plasma Neuro filament lite chain
Serum BDNF |
Baseline (0th day) and after 12 weeks |
|
|
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)
|
22/11/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
MCI represents a transitional stage between healthy aging and dementia, and affects 10–15% of the population and The annual conversion rate from MCI to AD has been reported as 10 to 15% (Dubois B etal2010, Albert MSetaal 2011,)and 80% of these patients will have converted to AD after approximately six years of follow-up. Currently, there are no accepted pharmacologic treatments for MCI approved by the FDA. Pharmacological and nonpharmacological treatments are used to prevent more reduction of cognition in MCI (Pinto C etal 2009) and is limited to the patients who are at higher risk of transition to AD. Brahmi is a promising herb known for its cognitive-enhancing properties and is widely used.
This study is a Double-blind randomized placebo-controlled trial to evaluate the efficacy of Brahmi ghrita in a dose of 15 ml twice daily for a period of 12 weeks in patients diagnosed with amnestic single or multi-domain MCI. The trial group will receive brahmi ghrita and the Control group will receive plain cow ghee in addition to the standard care they receive. The sample size is 30 in each groups. The primary outcome measure involves memory, attention and executive functions which will be assessed using NIHANS Neuropsychological battery for the elderly. secondary outcome measures are Neurofilament lite chain (marker of degeneration) and BDNF (neurotrophic factor). The duration of intervention is for 12 weeks with two assessment points at baseline and after 12 weeks. |