| CTRI Number |
CTRI/2023/01/049134 [Registered on: 20/01/2023] Trial Registered Prospectively |
| Last Modified On: |
17/01/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
comparative therapeutic evaluation of plain and medicated Bukhoor in the management of nonspecific low back pain. |
|
Scientific Title of Study
|
A randomized single blind multi-arm study for comparative therapeutic evaluation of plain and medicated bukhoor (plain and medicated vapour therapy)in the management of non specific low back pain |
| Trial Acronym |
PAMBP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ASIA SULTANA |
| Designation |
PROFESSOR |
| Affiliation |
ALIGARH MUSLIM UNIVERSITY |
| Address |
DEPARTMENT OF ILAJ-BIT-TADBEER, AJMAL KHAN TIBBIA COLLEGE, ALIGARH MUSLIM UNIVERSITY, ALIGARH
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
8755199034 |
| Fax |
000 |
| Email |
aasia.sultana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ASIA SULTANA |
| Designation |
PROFESSOR |
| Affiliation |
ALIGARH MUSLIM UNIVERSITY |
| Address |
DEPARTMENT OF ILAJ-BIT-TADBEER, AJMAL KHAN TIBBIA COLLEGE, ALIGARH MUSLIM UNIVERSITY, ALIGARH
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
8755199034 |
| Fax |
000 |
| Email |
aasia.sultana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ASIA SULTANA |
| Designation |
PROFESSOR |
| Affiliation |
ALIGARH MUSLIM UNIVERSITY |
| Address |
DEPARTMENT OF ILAJ-BIT-TADBEER, AJMAL KHAN TIBBIA COLLEGE, ALIGARH MUSLIM UNIVERSITY, ALIGARH
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
8755199034 |
| Fax |
000 |
| Email |
aasia.sultana@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Ilaj Bit Tadbeer, Ajmal Khan Tibbiya College, Aligarh Muslim University, Aligarh. |
|
|
Primary Sponsor
|
| Name |
Aligarh Muslim University |
| Address |
Ajmal Khan Tibbiya College |
| 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 |
| Prof Asia Sultana |
Ajmal Khan Tibbiya College |
Department of Ilaj Bit Tadbeer, Ajmal Khan Tibbiya College, AMU
Aligarh
UTTAR PRADESH |
8755199034
aasia.sultana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bukhoor |
Bukhoor with medicated vapour.
Duration: 30 days
|
| Intervention |
Bukhoor |
Bukhoor with plain water
and
Bukhoor with medicated vapour
Duration: 30 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically diagnosed patients with low back pain as the chief complaint. characterized by intermittent, recurrent, and episodic problems; and includes four types of pain: local, referred, radicular, and that arising from secondary(protective) muscular spasm.
2. Lower back pain persisting for 4 weeks or more.
3. Patients of either gender.
4. Age bracket 18-50 years.
5. Patient willing to abide for protocol guidelines.
|
|
| ExclusionCriteria |
| Details |
1. Age below 18 years and above 50 years.
2. Recent low back injury.
3. Pregnant and lactating women.
4. Any specific pathology. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in :
 Sign symptoms
 VAS
 Oswestry low back pain disability scale
 SF-12
 Mc Gill Pain Questionnaire.
|
30 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
ELISA
OSI(Oxidative stress index) |
Before treatment and After treatment. |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
27/01/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
| Background: Low Back pain especially Non-specific low back pain is very prevalent so we need to find effective alternative treatments having minimal side effects.
Purpose: The purpose of the trial is to find the safe and effective treatment of Non-specific low back pain outside pharmacotherapy. | |