| CTRI Number |
CTRI/2024/10/074893 [Registered on: 08/10/2024] Trial Registered Prospectively |
| Last Modified On: |
03/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical Efficacy of Unani Protocol in the Management of Falij e Nisfi |
|
Scientific Title of Study
|
Clinical Efficacy of Unani Protocol ( Munzij, Mushil, Tabreed & Muqawwiyaat Formulation) in the Management of Falij e Nisfi (Aisar/Aimen) (Hemiplegia) Cerebral Stroke |
| 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 N M Sarfaraz Nawaz |
| Designation |
P G Scholar |
| Affiliation |
Government Nizamia Tibbi College |
| Address |
OP No 1 PG Department of Moalijat, Government Nizamia Tibbi College and General Hospital, Charminar Hyderabad
Hyderabad
TELANGANA
500002
India |
| Phone |
8121786637 |
| Fax |
|
| Email |
drnawazqadri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Syed Abdul Khadir Hussaini |
| Designation |
Professor |
| Affiliation |
Government Nizamia Tibbi College and General Hospital |
| Address |
Room No 215 and Room No 1, P G Department of Moalijat, Government Nizamia Tibbi College and General Hospital, Charminar, HYderabad.T.S
Hyderabad
TELANGANA
500002
India |
| Phone |
9704888561 |
| Fax |
|
| Email |
drsakhussaini@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr N M Sarfaraz Nawaz |
| Designation |
PG Scholar |
| Affiliation |
Government Nizamia Tibbi College and General Hospital |
| Address |
OP No 1,
P G Department of Moalijat, Government Nizamia Tibbi College and General Hospital, Charminar, HYderabad.T.S
Hyderabad
TELANGANA
500002
India |
| Phone |
8121786637 |
| Fax |
|
| Email |
drnawazqadri@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Nizamia Tibbi College and General Hospital Charminar Hyderabad Telangana 500004 India |
|
|
Primary Sponsor
|
| Name |
Government Nizamia Tibbi College and General Hospital Charminar Hyderabad Telangana |
| Address |
PG Department of Moalijat Government Nizamia Tibbi College and General Hospital Charminar Hyderabad Telangana 500004 India |
| 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 N M Sarfaraz Nawaz |
Government Nizamia Tibbi College and General Hospital |
OP No 1 PG Department of Moalijat, Government Nizamia Tibbi College and General Hospital, Charminar Hyderabad
Hyderabad
TELANGANA |
08121786637
drnawazqadri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethic Committee IEC |
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 |
Unani Protocol- |
Each patient is treated with Unani protocol with duration of 28 days which is in the form of Munzij:-250 ml Joshanda (Decoction) of Beekh e Badyan, Beekh e Kibr, Beekh e Karafs, Beekh e Azkhar, Beekh e Kasni, Tukhm e Kasni, Tukhm e Karafs, Baadyan, Ustukhudus, Aslussoos, Parsiyaaoshaan, Unnab, Anjeer and Moeez Munaqqa administered for 21 days.
Mushil:- On 22nd, 24th, 26th day Mushil e Balgham is given the ingredients are Turbud sufaid, Sanamaki, Zanjabeel, Gul e Surkh, Tamarhindi, Maghz e Amaltaas, Tukhm e Badyan. Alternate days i.e., 22, 24, 26th day.
Tabreed:- On 23rd , 25th & 27th day Arq e Gauzabaan/ Khameera Gauzaban is given in Nuskh e Tabreed.
Muqawwiyaat:- On 28th day onwards 5 gms of Majun e Aasabi/Majun e Falasafa given twice a day orally before food.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Post Stroke disability cases with less than 50% score according to Barthel Index.
2 Patients with Ischaemic Stroke.
3 Patients having history of Stroke for not more than 3 months.
|
|
| ExclusionCriteria |
| Details |
1.Patients with T.I.A ( Transient Ischaemic Attack) and others types.
2.Pregnant and lactating women.
3.Patients with Cardiac, Pulmonary, Hepatic & Renal Disorders.
4. Post stroke disability cases with more than 50% score on Barthel Index.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to improve the activities of Daily Living (ADLs) independently |
once in a week followed by alternate days up to 28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To know muscle strength, spasticity and flaccidity |
once in a week followed by alternate days up to 28th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/10/2024 |
| 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="0"
Months="0"
Days="28" |
|
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
|
Sroke
is one of the main Global causes of Mortality & Morbidity. To evaluate the efficacy of Unani formulations ( Munzij, Mushil, Tabreed & Muqawwiyaat)
and its sufficient patient data on Cerebral Stroke is not
available with either institutions to prove the cited Unani formulations are
result oriented. To clinically evaluate the effect of unani protocol in the management of Cerebral Stroke with sample size of 30 and 28 days of treatment with inclusion and exclusion criteria the study has been planned |