| CTRI Number |
CTRI/2024/06/069454 [Registered on: 25/06/2024] Trial Registered Prospectively |
| Last Modified On: |
21/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of chewing drugs versus Speech Language Therapy in speech problem due to stroke |
|
Scientific Title of Study
|
Efficacy of Mazoogh (Masticatory drugs) Versus Speech
Language Therapy in Taghayyur–i-Kalam (Aphasia) in Post
Stroke patients |
| 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 Shaik Adeena Parveen |
| Designation |
PG Scholar Department of Ilaj bit Tadbeer |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Department of Ilaj bit Tadbeer,National Institute of Unani Medicine,
Kottigepalya,Magadi main road, Bangalore,560091
Bangalore
KARNATAKA
560091
India |
| Phone |
8074058656 |
| Fax |
|
| Email |
adeenaparveen99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Abdul Nasir Ansari |
| Designation |
Head of Department |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Department of Ilaj bit Tadbeer,National Institute of Unani Medicine,
Kottigepalya,Magadi main road, Bangalore,560091
Bangalore
KARNATAKA
560091
India |
| Phone |
9379165162 |
| Fax |
|
| Email |
abdulnasiransari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Abdul Nasir Ansari |
| Designation |
Head of Department |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Department of Ilaj bit Tadbeer,National Institute of Unani Medicine,
Kottigepalya,Magadi main road, Bangalore,560091
Bangalore
KARNATAKA
560091
India |
| Phone |
9379165162 |
| Fax |
|
| Email |
abdulnasiransari@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Unani Medicine,Kottigepalya,Magadi main road,Bangalore,560091,Karnataka |
|
|
Primary Sponsor
|
| Name |
National Institute of Unani Medicine |
| Address |
National Institute of Unani Medicine,Kottigepalya,Magadi main road,Bangalore,Karnataka,India,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 Shaik Adeena Parveen |
National Institute of Unani Medicine |
Department of Ilaj bit Tadbeer,OPD 28,National Institute of Unani Medicine,Kottigepalya,Magadi main road,Bangalore,Karnataka,India ,560091
Bangalore
KARNATAKA |
8074058656
adeenaparveen99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of Decision of the 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: G819||Hemiplegia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mazoogh(Masticatory Drugs) |
The test group will be given 5 grams of coarse powder of Mazoogh to chew twice a
day after meals for 30 days. |
| Comparator Agent |
Speech Language Therapy |
The control group will be treated with Speech-Language Therapy for 30
minutes daily for 30 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects from 18 to 70 years of age
2.All genders
3.Clinically and radiologically diagnosed cases of aphasia
4.A score less than 93.8 on the Aphasia Quotient of the Western Aphasia Battery-Revised Aphasia Quotient |
|
| ExclusionCriteria |
| Details |
1. Subjects less than 18 or more than 70 years of age
2. Neurological condition other than stroke
3. A previous history of mental illness and dementia
4. A concurrent progressive Neurological disorder
5. Uncontrolled comorbidities such as Hypertension, DM, Hepatic and Renal diseases
6. Uncorrected hearing or vision impairment
7. Clinical depression at the time of admission
8. Unwillingness or inability to comply with the requirements of the protocol |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Western Aphasia Battery-Revised Aphasia Quotient
|
At baseline , 2 weeks , 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No Secondary Outcome |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
02/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
02/07/2024 |
| 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 : Efficacy of Mazoogh (Masticatory drugs) Versus Speech Language Therapy in Taghayyur I Kalam (Aphasia) in post stroke Design : Open-labelled, Parallel groups, Randomised Controlled Clinical study Intervention :The test group will be given 5 grams of coarse powder of Mazoogh to chew twice a day after meals for 30 days. The control group will be treated with Speech-Language Therapy for 30 minutes daily for 30 days Main outcome measure : Primary outcome : Western Aphasia Battery-Revised Aphasia Quotient |