| CTRI Number |
CTRI/2024/07/070613 [Registered on: 15/07/2024] Trial Registered Prospectively |
| Last Modified On: |
17/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Other |
|
Public Title of Study
|
Efficacy of massage therapy in Patient suffering from Sciatica pain, |
|
Scientific Title of Study
|
Clinical Efficacy of Dalk Mutadil (Moderate Massage) with Rogan-E-Qust in The Management of Irqun Nasa (Sciatica) |
| 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 Anwarul Haq |
| Designation |
PG Scholar Department of Ilaj-Bit Tadbeer |
| Affiliation |
Government Unani Medical College, Chennai |
| Address |
Department of Ilaj-Bit Tadbeer,
Room No. 103
Government Unani Medical College, Anna Hospital campus, P.H. Road,Arumbakkam,
Chenai
Chennai
TAMIL NADU
600106
India |
| Phone |
9452336196 |
| Fax |
|
| Email |
haqanwar84@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nizamudeen S |
| Designation |
Associate Professor |
| Affiliation |
Government Unani Medical College, Chennai |
| Address |
Government Unani Medical College,
Department of Ilaj-Bit Tadbeer,
Room no. 103,
Anna Hospital Campus,
P.H. Road, Arumbakkam,
Chennai 600106
Chennai
TAMIL NADU
600106
India |
| Phone |
8754404152 |
| Fax |
|
| Email |
drnizamgumc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nizamudeen S |
| Designation |
Associate Professor |
| Affiliation |
Government Unani Medical College, Chennai |
| Address |
Department of Ilaj-Bit Tadbeer
Room No. 103
Government Unani Medical College, Anna Hospital campus, P.H. Road,Arumbakkam,
Chenai
Chennai
TAMIL NADU
600106
India |
| Phone |
8754404152 |
| Fax |
|
| Email |
drnizamgumc@gmail.com |
|
|
Source of Monetary or Material Support
|
| AAGHIM Anna Hospital Campus , Arumbakkam, Chennai 600106 |
|
|
Primary Sponsor
|
| Name |
Government Unani Medical College Chennai |
| Address |
Govt Unani Medical College,
AAGHIM Campus
Arumbakkam,
Chennai 106 |
| Type of Sponsor |
Government 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 Anwarul Haq |
Govt Unani Medical College, |
GUMC
Department of Ilaj-Bit Tadbeer
OPD No 103
Arumbakkam
Chennai
600106
Chennai
TAMIL NADU |
9452336196
haqanwar84@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of Decision of the Institutional Ethics Commitee (IEC) for Biomedical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M255||Pain in joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dalk Mutadil |
Dalk Mutadil with 25ml of Roghan e Qust for days, about 10-15 minutes on 0, 1, 3, 7, 14, 21 and 28 days |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age from 20 to 60 years (Sine saba and Sine Kahulat )
2.Patients of either sex between the ages of 20 to 60 years
3.Already diagnosed patients of sciatica presenting with all or some of the following signs and symptoms
a. Unilateral leg pain greater than low back pain
b. Pain radiating to foot or toes
c. Tingling, pins and shooting pain
d. Numbness or paraesthesia in the same distribution
|
|
| ExclusionCriteria |
| Details |
1.Patient below 20 years and above 60 years of age
2. Patient of vertebral fractures and spinal tumours
3. Patient of spinal deformities
4. Patient of previous back surgery/lumbar spine surgery
5. Patient with bleeding disorders
6. Patient on anticoagulant treatment or DIC (Disseminated intravascular coagulopathies
7. Patients with systemic disorders like uncontrolled diabetes mellitus, chronic liver disease, kidney disease, heart disease (CAD, ACS)
8. Terminally ill patient
9. Pregnant and lactating mother |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in clinical symptoms, Change in subjective parameters, on Visual Analogue Scale (VAS)
SLR Test |
28 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in Quality of life on objective parameters-
Oswestry disability index (ODI) |
28 Days |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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)
|
25/07/2024 |
| 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
Modification(s)
|
Efficacy of Dalk Mu’tadil with Rogan-e-Qust in the management of Irqun-Nasa (Sciatica). Duration: 28 days Sample size: 30 IEC No:GUMC/IEC/2022-2023/MJ/23/05 Outcome: Primary Outcome: The outcome will be mainly assessed by reduction in clinical symptoms after the treatment and assessing the improvement of the patient from severe to moderate, moderate to mild. SECONDARY OUTCOME: Radiological Parameters, if required Objective of the study: To assess the role of clinical efficacy of “Dalk with Rogan Qust†in the management of Irqun-nasa.
|