| CTRI Number |
CTRI/2023/08/056170 [Registered on: 04/08/2023] Trial Registered Prospectively |
| Last Modified On: |
28/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study efficacy of Bramhi Ghrita in Mild Cognitive Impairment (Smrutimandya/ memory loss ) |
|
Scientific Title of Study
|
An Exploratory clinical trial to assess the efficacy of Brahmi Ghrita in Mild Cognitive impairment (MCI) |
| 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 Rupali Tarachand Khobragade |
| Designation |
Professor |
| Affiliation |
PDEAs College of Ayurveda and Research Centre Nigdi Pune |
| Address |
PDEAs College of Ayurveda and Research Centre Kayachikitsa Department Nigdi Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
8378929859 |
| Fax |
|
| Email |
khobragaderupali19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rupali Tarachand Khobragade |
| Designation |
Professor |
| Affiliation |
PDEAs College of Ayurveda and Research Centre Nigdi Pune |
| Address |
PDEAs College of Ayurveda and Research Centre Kayachikitsa Department Nigdi Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
8378929859 |
| Fax |
|
| Email |
khobragaderupali19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rupali Tarachand Khobragade |
| Designation |
Professor |
| Affiliation |
PDEAs College of Ayurveda and Research Centre Nigdi Pune |
| Address |
PDEAs College of Ayurveda and Research Centre Kayachikitsa Department Nigdi Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
8378929859 |
| Fax |
|
| Email |
khobragaderupali19@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDESs College of Ayurveda and Research Centre Kayachikitsa DEpartment Nigdi Pune |
|
|
Primary Sponsor
|
| Name |
PDESs College of Ayurveda and Research Centre Nigdi Pune |
| Address |
PDESs College of Ayurveda and Research Centre Kayachikitsa DEpartment Nigdi Pune |
| Type of Sponsor |
Private medical college |
|
|
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 Rupali Tarachand Khobragade |
PDEAs Ayurved Rugnalaya and Sterling Multispecialty Hospital Pune |
PDEAs Ayurved Rugnalaya and Sterling Multispecialty Hospital, OPD no 117A, sector 27 pradhikaran Nigdi Pune
Pune
MAHARASHTRA |
8378929859
khobragaderupali19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F70||Mild intellectual disabilities. Ayurveda Condition: MANOVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Bramhi Ghrita, Reference: NA, Route: Oral, Dosage Form: Ghrita, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Koshnajal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients of either sex having age above 50 yrs. below 80yrs.
2) Patients having symptoms of Mild Cognitive impairment(MCI) |
|
| ExclusionCriteria |
| Details |
1) Known case of Dementia, Alzheimer’s disease
2) Patients with evidence of delirium and other disturbances of consciousness
3) Patients having complications of major illness such as Liver/Kidney failure
4) Known case of Encephalopathy, Epileptic attacks, Coagulopathies, Neuromuscular diseases, Cancer, Stroke, intracranial hemorrhage, brain tumors and brain surgeries.
5) Patients using any type of psychotropic drugs.
6) Uncontrolled DM(HbA1C> 7.5) and its complications
7) Uncontrolled HTN (Systolic >160 &Diastolic>100) and it’s complications
8) Immunocompromised patients
9) patients having Hb<8 g/dl
10) Patients having Dyslipidemia especially Sr Cholesterol >220 mg/dl, Sr Triglycerides > 180 mg/dl, Sr LDL > 150 mg/dl.
11) BMI > 40 and < 18
12) Patients with physical impairment, such as walking, sitting, bladder and bowel incontinence
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1) To evaluate efficacy of Brahmi Ghrita in Mild Cognitive impairment (MCI) in Elderly people. |
1 week, 4 week, 8 week , 12 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to study adverse drug reaction if any |
3 months |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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 1 |
|
Date of First Enrollment (India)
|
17/08/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Mild Cognitive Impairment (MCI )is the most commonly observed disease amongst elderly people and it is responsible for developing the diseases like Dementia and Alzheimer’s disease(AD) (1) MCI is the most important stage between normal ageing and dementia. Prevalence of MCI observed globally is 15.56%(2). The high conversion rate from MCI to AD places a large burden on individual and family. Thus, it is a need of time to pay attention to the treatment of MCI. Comorbidities especially Hypertension and Diabetes aggravates MCI in elderly people therefore it needs to get controlled. According to Sharangadhara Acharya, Medha (grasping and retention power) starts declining after the fourth decade of life and this may be considered as an alarming signal for further decline of Smriti (memory) and Buddhi (intellect), in the successive years. Rasayana Chikitsa has a major role to play in this arena. Nootropic drugs like Guduchi, Ashwagandha, Brahmi, Shankhapushpi various ghritas have proven efficacy in cognitive domains of psychological wellbeing. Brahmi being the most effective and safe drug is chosen for the present study in the form of Brahmi Ghrita |