| CTRI Number |
CTRI/2022/04/041903 [Registered on: 19/04/2022] Trial Registered Prospectively |
| Last Modified On: |
11/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Aparajita tablet against Yashtimadhu tablet in mild cognitive impairment |
|
Scientific Title of Study
|
A double blind randomized controlled trial to assess the efficacy of Aparajita tablet against Yashtimadhu tablet in mild cognitive impairment |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anjali A |
| Designation |
PG Scholar |
| Affiliation |
VPSV Ayurveda College |
| Address |
PG Scholar
Manovigyan Avum Manasroga
Department of Kayachikitsa
VPSV Ayurveda College
Kottakkal
Malappuram
KERALA
676501
India |
| Phone |
8075850416 |
| Fax |
|
| Email |
rithooz@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satheesh K MDAy |
| Designation |
Associate Professor |
| Affiliation |
VPSV Ayurveda College , Kottakkal |
| Address |
Dr Satheesh K
Associate professor
department of Kayachikitsa
VPSV Ayurveda College
kottakkal
Malappuram
KERALA
676501
India |
| Phone |
9249993257 |
| Fax |
|
| Email |
drsatheeshpdm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Satheesh K MDAy |
| Designation |
Associate Professor |
| Affiliation |
VPSV Ayurveda College , Kottakkal |
| Address |
Dr Satheesh K
Associate professor
department of Kayachikitsa
VPSV Ayurveda College
kottakkal
Malappuram
KERALA
676501
India |
| Phone |
9249993257 |
| Fax |
|
| Email |
drsatheeshpdm@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of kayachikitsa
VPSV Ayurveda College
Kottakkal
Malappuram
Kerala
|
|
|
Primary Sponsor
|
| Name |
Anjali A |
| Address |
PG Scholar
Manovigyan Avum Manasroga
department of Kayachikitsa
VPSV Ayurveda College
kottakkal |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Anjali A |
VPSV Ayurveda College Kottakkal Edarikode Malappuram Kerala pin 676501 |
Manovigyan avam manasroga
Dept. of Kayachikitsa
Malappuram
KERALA |
8075850416
rithooz@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board , VPSV Ayurveda College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F068||Other specified mental disorders due to known physiological condition. Ayurveda Condition: medhAkShaya, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Aparajita, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 4(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Milk), Additional Information: -Will compare with Yashtimadhu tablet, 2 bid with luke warm milk for 2 month, followed by 1 month follow up in 2 groups | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Yashtimadhu, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 4(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -milk ), Additional Information: -2bid daily with luke warm milk for a period of 2 months and follow up after 1 month |
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
a) Diagnosed cases of Mild Cognitive Impairment as per DSM V diagnostic criteria.
b) Age between 50-70 years.
c) Those willing to give written consent.
d) Those whose MMSE Score lies between 19-23.
e) Those who diagnosed with Type II Diabetes Mellitus.
f) No discrimination of gender, religion and economic status. |
|
| ExclusionCriteria |
| Details |
a) Subjects who have decline in cognitive functions as a result of trauma, surgery
cardiovascular diseases, stroke, thyroid dysfunction, chronic kidney diseases,
chronic liver diseases.
b) Those having major psychiatric co-morbidities. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacies of AparÄjita cÅ«rņa and Yaá¹£á¹imadhu cÅ«rņa in Mild Cognitive Impairment by using MMSE
To compare the Quality of Life of subjects with Mild Cognitive Impairment in study and
control groups.
|
Three months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
30/04/2022 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Mild Cognitive Impairment is taken as the transient stage between normal ageing & Dementia and can have problems with memory, language, thinking & judgment. The chances of progression of Mild Cognitive Impairment into any form of Dementia is suggested as 3-5 times higher when compared with normal people.Hence clinical studies & proper treatments may improve symptoms or delay further progression of Mild Cognitive Impairment into Dementia.A previous study was conducted on Yaá¹£á¹imadhu cÅ«rņa and its effect was proven in Mild Cognitive Impairment. A well-known MÄ“dhya rasÄyana, AparÄjita having special mÄ“dhyaguņa property known for its nootropic & neuroprotective action is taken as the study drug since there is no scientific studies are conducted to evaluate its role in Mild Cognitive Impairment. Hence the current study is planned to compare the efficacies of AparÄjita cÅ«rņa and Yaá¹£á¹imadhu cÅ«rņa in Mild Cognitive Impairment.40 participants satisfying the inclusion criteria will be selected from the OPD of VPSV Ayurveda College Hospital, Kottakkal and randomly divided into two groups, 20 in each group by using random number table method. In one group AparÄjita cÅ«rņa and in second group Yaá¹£á¹imadhu cÅ«rņa in a dose of 1.5 gm in Tablet form twice daily with lukewarm milk after food for 2 months will be given. Assessments will be done before treatment, after one month and two months of treatment and followed up after one month using Mini Mental Status Examination and Montreal Cognitive Assessment. Quality of life will be assessed using the WHOQOL BREF Scale before treatment, after two months of treatment and after one month of follow up. Aim of the study is to provide a better and convenient Ayurvedic management for Mild Cognitive Impairment. Primary Objective is to compare the efficacies of AparÄjita cÅ«rņa and Yaá¹£á¹imadhu cÅ«rņa in Mild Cognitive Impairment. Secondary Objective is to compare the Quality of Life of subjects with Mild Cognitive Impairment in study and control groups. |