| CTRI Number |
CTRI/2024/06/068413 [Registered on: 05/06/2024] Trial Registered Prospectively |
| Last Modified On: |
22/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Unani Medicine in Intellectual Deficit in Stroke Patients |
|
Scientific Title of Study
|
Efficacy of Waj in post-stroke cognitive impairment: A 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 Ruksar Ayesha |
| Designation |
PG Scholar |
| Affiliation |
National institute of unani medicine, Kottigepalya, Magadi main road Bangalore KARNATAKA |
| Address |
Department of Moalajat
National institute of unani medicine, Kottigepalya,
Magadi main road
Bangalore
KARNATAKA
560091
India
Bangalore
KARNATAKA
560091
India |
| Phone |
8197234346 |
| Fax |
|
| Email |
ruksarayesha123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Muzafar Din Ahmad Bhat |
| Designation |
Assitant Professor |
| Affiliation |
National institute of unani medicine, Kottigepalya, Magadi main road Bangalore KARNATAKA |
| Address |
Department of Moalajat
National institute of unani medicine, Kottigepalya,
Magadi main road
Bangalore
KARNATAKA
560091
India
Bangalore
KARNATAKA
560091
India |
| Phone |
9590366192 |
| Fax |
|
| Email |
drmuzaffar79@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Muzafar Din Ahmad Bhat |
| Designation |
Assitant Professor |
| Affiliation |
National institute of unani medicine, Kottigepalya, Magadi main road Bangalore KARNATAKA |
| Address |
Department of Moalajat
National institute of unani medicine, Kottigepalya,
Magadi main road
Bangalore
KARNATAKA
560091
India
Bangalore
KARNATAKA
560091
India |
| Phone |
9590366192 |
| Fax |
|
| Email |
drmuzaffar79@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Unani Medicine, Bangalore |
|
|
Primary Sponsor
|
| Name |
National Institute of Unani Medicine |
| Address |
Kottigepalya, Magadi main road Bangalore Karnataka 560091 |
| 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 Ruksar Ayesha |
National Institute of Unani Medicine |
Department of Moalajat OPD and IPD
Bangalore
KARNATAKA |
8197234346
ruksarayesha123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(IEC) for Biomedical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F70-F79||Intellectual disabilities, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Placebo (wheat flour) 3gm will be given in capsule form daily in two divided doses for 6 weeks |
| Intervention |
Waj |
3gm of Waj will be given in capsule form daily in 2 divided doses for 6 weeks, each capsule will contain 750 mg of waj |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1)Age ranges from 30 to 75 years (30 and 75 also included), no gender limitation.
2)The presence of cognitive impairments (Montreal Cognitive Assessment, MoCA less than 26).
3)Patients having single ischaemic or haemorrhagic stroke documented by cerebral CT scanning or MRI before enrolment.
4)Patients having history of stroke more than 6 weeks.
5)No severe aphasia and able to accomplish cognitive tests.
6)Stable vitals, no progression of neurological symptoms.
7) Normal cognitive function before stroke.
8)Voluntary participation and signing the informed consent.
9)Educational level should be primary school or above, with the capability of finishing cognitive tests.
|
|
| ExclusionCriteria |
| Details |
1)Patients with pre stroke cognitive impairment.
2)Any neuropsychiatric comorbidity and affective disorder that could influence the test outcomes.
3)Patients with uncorrectable visual or hearing disturbances severe enough to preclude cognitive tests.
4)History of transcranial surgery or skull defect
5)Previous history of more than one episode of stroke.
6)Severe Aphasia.
7)Chronic Alcoholism.
8)Uncontrolled hypertension and Diabetes mellitus.
9)A medical condition that, in the investigator opinion, would interfere with treatment, safety, or adherence to the protocol.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • Improvement in Montreal Cognitive Assessment (MoCA) to evaluate the general cognitive function |
0, 14th, 28th, and 42nd day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • Improvement in Activities of Daily Living (ADL) assessed with the Barthel Index (BI) |
0,and 42nd day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2 |
|
Date of First Enrollment (India)
|
10/06/2024 |
| 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="1"
Months="6"
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
|
Purpose: To Evaluate the Efficacy of Waj in Post-stroke Cognitive Impairment Design: A Double Blind Randomized Placebo Controlled Study Intervention: Test group will be given research drug (Waj) 3gm in two divided doses daily and control group will be given placebo (wheat flour) same as test group Main outcome measures: Primary outcome: Improvement in Montreal Cognitive assessment Score Secondary outcome: Improvement in Activities of daily living assessed by Barthel Index |