| CTRI Number |
CTRI/2019/05/018972 [Registered on: 07/05/2019] Trial Registered Prospectively |
| Last Modified On: |
02/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
effect of herbal formulation on knee joint pain |
|
Scientific Title of Study
|
Effect of polyherbal formulation in the treatment of Osteoarthritis Knee Joint: a randomized single blind standard controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sayyed Abuzar Gaffari |
| Designation |
PG scholar |
| Affiliation |
Luqman Unani Medical College Hospital and Research Centre |
| Address |
Dept of Moalejat, Luqman Unani Medical college hospital and research centre, 12 Naubaug Bijapur
Dept of Moalejat, Luqman Unani Medical college hospital and research centre, 12 Naubaug Bijapur
Bijapur
KARNATAKA
586104
India |
| Phone |
7978560952 |
| Fax |
|
| Email |
drsayyedabuzar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
arshid iqbal wani |
| Designation |
assitant professor |
| Affiliation |
Luqman Unani Medical College Hospital and Research Centre |
| Address |
Dept of Moalejat, Luqman Unani Medical college hospital and research centre, 12 Naubaug Bijapur
Dept of Moalejat, Luqman Unani Medical college hospital and research centre, 12 Naubaug Bijapur
Bijapur
KARNATAKA
560091
India |
| Phone |
9742863126 |
| Fax |
|
| Email |
arshidwani456@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
arshid iqbal wani |
| Designation |
MD Scholar |
| Affiliation |
Luqman Unani Medical College Hospital and Research Centre |
| Address |
Dept of Moalejat, Luqman Unani Medical college hospital and research centre, 12 Naubaug Bijapur
Dept of Moalejat, Luqman Unani Medical college hospital and research centre, 12 Naubaug Bijapur
Bijapur
KARNATAKA
560091
India |
| Phone |
09742863126 |
| Fax |
|
| Email |
arshidwani456@gmail.com |
|
|
Source of Monetary or Material Support
|
| Luqman Unani Medical college hospital and research centre
12 naubaug ,bijapur 586104 karnataka |
|
|
Primary Sponsor
|
| Name |
Sayyed Abuzar Gaffari |
| Address |
Dept of Moalejat, Luqman Unani Medical college hospital and research centre, 12 Naubaug Bijapur |
| Type of Sponsor |
Other [self] |
|
|
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 sayyed abuzar gaffari |
Luqman Unani Medical College Hospital and Research Centre |
Dept of Moalejat, Luqman Unani Medical college hospital and research centre, 12 Naubaug Bijapur
Bijapur
KARNATAKA |
7978560952
drsayyedabuzar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Aceclofenac |
100mg twice daily, orally given for 30 days |
| Intervention |
Polyherbal formulation. |
Majoon (semi-solid) in which Haleela Zard 70 gram
Suranjan 10.05gram
Bozidan 10.05gram
Tukhm e Karafs 7gram
Aneesun 7 gram presentand given orally as 7gram once a day for 30 days
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with primary osteoarthritis, fulfilling the ACR clinical/radiological classification criteria.
Patients of both genders between the age group of 35 to 65 years.
|
|
| ExclusionCriteria |
| Details |
Patients suffering with other forma of arthritis like, rheumatoid arthritis, rheumatic arthritis, psoriatic arthritis, ankylosing spondylitis gouty arthritis, infective arthritis, and systemic lupus erythematous (SLE).
• Patients suffering from systemic diseases, like diabetes, endocrinal disorders, malignancies etc.
• Patients with BMI ≥30.
Patients giving the History of recent accident or trauma.
Patients with severe restricted mobility.
Pregnant and lactating mothers.
Sever Hb%
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reducing the pain from baseline to the end of treatment. |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reducing the WOMAC score and improving the quality of life and also to assess its effect on other subjective parameters from baseline to end of treatment. |
21 days |
|
|
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)
|
23/05/2019 |
| 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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
40
eligible patients of Osteoarthritis Knee, after obtaining written informed consent will be randomly
allocated either to test (n=20) or control group (n=20). Patients will be
blinded for the study. In the test group; Polyherbal formulation 7 gram in the form of majoon will be give once a
day for 21 days
orally. In the control drug 1Tablet Aceclofenac 100mg
will be given orally morning
and evening for 21 days. The follow up
of patients will be done at 7th, 14th and 21th . Assessment of
subjective parameters will be done on each visit and objective parameterswill
be assessed before and after treatment. |