| CTRI Number |
CTRI/2020/03/024187 [Registered on: 23/03/2020] Trial Registered Prospectively |
| Last Modified On: |
09/03/2020 |
| 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
|
A comparative Clinical Study to evaluate the safety and efficacy of a unani formulation in the Management of Waja‘al-MafÄá¹£il (Rheumatoid Arthritis) |
|
Scientific Title of Study
|
A Randomized, Active-Controlled, Assessor-Blinded, Parallel Group Clinical Study to evaluate the safety and efficacy of Qurs-e-Mafasil in the Management of Waja‘al-MafÄá¹£il (Rheumatoid Arthritis) |
| Trial Acronym |
RCT RA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ansari Umme Ammara Maqbool Ahmad |
| Designation |
Research Scholar |
| Affiliation |
National Research Institute of Unani Medicine for Skin Disorders |
| Address |
National Research Institute of Unani Medicine for Skin Disorders,
AG Colony Road, Opp. ESI Hospital, Erragadda
Hyderabad
TELANGANA
500038
India |
| Phone |
9762124018 |
| Fax |
|
| Email |
ansariammara8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Qamar Uddin |
| Designation |
Professor |
| Affiliation |
National Research Institute of Unani Medicine for Skin Disorders |
| Address |
National Research Institute of Unani Medicine for Skin Disorders,
AG Colony Road, Opp. ESI Hospital, Erragadda
Hyderabad
TELANGANA
500038
India |
| Phone |
8700027178 |
| Fax |
|
| Email |
ccrumhqrsnd58@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohammad Nawab |
| Designation |
Reader |
| Affiliation |
National Research Institute of Unani Medicine for Skin Disorders |
| Address |
National Research Institute of Unani Medicine for Skin Disorders,
AG Colony Road, Opp. ESI Hospital, Erragadda
Hyderabad
TELANGANA
500038
India |
| Phone |
8100992044 |
| Fax |
|
| Email |
ccrumnawab@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Research Institute of Unani Medicine for Skin Disorders,
AG Colony Road, Opp. ESI Hospital, Erragadda, Hyderabad-500 038 |
|
|
Primary Sponsor
|
| Name |
National Research Institute of Unani Medicine for Skin Disorders Hyderabad |
| Address |
National Research Institute of Unani Medicine for Skin Disorders,
AG Colony Road, Opp. ESI Hospital, Erragadda, Hyderabad-500 038 |
| 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 |
| ANSARI UMME AMMARA MAQBOOL AHMAD |
National Research Institute of Unani Medicine for Skin Disorders, Hyderabad |
GOPD New building of National Research Institute of Unani Medicine for Skin Disorders,
AG Colony Road, Opp. ESI Hospital, Erragadda, Hyderabad-500 038
Hyderabad
TELANGANA |
9762124018
ansariammara8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Celecoxib 100mg |
Celecoxib in the dose of 1 tablet (100 mg) twice daily orally with water after meals for 4 weeks |
| Intervention |
Qurs-e-Mafasil |
Qurs-e-Mafasil in the dose of 2 tablets (500mg each) twice daily orally with water after meals for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients of any sex in the age group 35-55 years
Patients diagnosed with Waja‘al-MafÄá¹£il (Rheumatoid arthritis) on the basis of following ACR-EULAR criteria
1)Definite clinical synovitis (pain, swelling, tenderness) in at least 1 joint
2)Absence of an alternative diagnosis for the observed synovitis (arthritis)
3)Achievement of a total score of 6 or greater(of a possible 10) from the individual scores in 4 domains:
a)Number and site of involved joints(range 0-5)
b)Serological abnormalities (range 0-3)
c)Elevated acute phase reactants (range 0-1)
d)Duration of symptoms (range 0-1)
|
|
| ExclusionCriteria |
| Details |
Patients aged <35 years or >55 years
Rheumatoid arthritis with extra-articular manifestations, joint deformities, and advanced radiological lesions (e.g. joint subluxation and collapse)
History or clinical evidence of any systemic inflammatory condition other than RA such as, juvenile chronic arthritis, spondyloarthropathy,IBD , psoriatic arthritis, active vasculitis, or gout that may interfere with evaluation
Currently receiving or have intra-articular treatment (e.g. corticosteroids, or NSAIDS within 2 weeks of study entry and DMARDs or IFN therapy within 4 wks prior to study entry or are anticipated to require IFN therapy during study
History or clinical evidence of Gastritis/ Peptic Ulcer Disease/ Renal Impairment
History of hypersensitivity to study drug or any of its ingredients
Pregnant or Lactating Women
Hypertensive and Obese Subjects (BMI≥30)
H/o Addiction (alcohol, drugs)
Significant Pulmonary/Cardiovascular/Hepato-renal Dysfunction
Known cases of Immunocompromised states (HIV/ AIDS, etc.)/ Malignancies
Patient not willing to attend treatment schedule regularly
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical assessment will be done at 0, 1, 2, 3 and 4 weeks and the response to treatment will be assessed using the following parameters:
1) Visual Analogue Scale (VAS)
2) Disease Activity Score in 28 joints (DAS28)27 |
Clinical assessment will be done at 0, 1, 2, 3 and 4 weeks and the response to treatment will be assessed using the following parameters:
1) Visual Analogue Scale (VAS)
2) Disease Activity Score in 28 joints (DAS28)27 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Lab investigation and X-ray |
0,2, 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/05/2020 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Rheumatoid
arthritis(RA) is a chronic inflammatory disease of unknown etiology
characterized by a symmetric polyarthritis, the most common form of chronic
inflammatory arthritis.Since persistently active RA often result in articular
cartilage and bone destruction and functional disability,it is vital to
diagnose and treat thisdisease early
aggressively before damage
ensues.1
The
incidence of RA increases between 25 and 55 years of age, after which it
plateaus until the age of 75 and then decreases.1The prevalence of
RA is approximately 0.8-1% in Europe and the IndianSubcontinent,with a female
to male ratio of 3:1.2Rheumatoid arthritis(RA) is an autoimmune
disease with a worldwide prevalence of approximately 0.5 to 1% among adults.3
When RA
is left uncontrolled, the patient may experience joint deterioration, severe
disability, decreased quality of life, the onset of comorbidities and premature
mortality.The potential comorbidities include but are not limited to
cardiovascular disease(CVD), cancer(specifically lymphoma and lympho-proliferative
diseases, lung cancer and melanoma), infections, depression and
gastrointestinal disease.3
In Unani
system of medicine,Arthritis is described under broad termWaja‘al-MafÄá¹£il
which include entire joint disorders like inflammatory, non-inflammatory,infectious,
metabolic and other joint disorders.4
Population
studies and WHO statistic indicate that 10-50% of individuals suffer from musculoskeletal
disorders and almost all patients require non- steroidal anti-inflammatory
drugs(NSAIDs) and other analgesic for their management. The large majority of
this population is elderly and hence, greater risk of adverse effects,
Including gastritis, peptic ulcer and renal impairment.5 Disease-modifying
anti-rheumatic drugs(DMARDs) act by altering the underlying disease rather than
treating symptoms however some of the DMARDs use for the treatment of RA are
associated with pulmonary toxicity,cardiactoxicity, irreversible retinal
damage,hepatotoxicity, myelosuppression and reactivation of latent TB and
increased risk of all types of infection including fungal infection by TNF-α
inhibitors. Chronic use of Glucocorticoids
in treatment of RA can cause osteoporosis and other long-term
complication.1
Despite of wide range of treatment available in conventional system of
medicine, there is no cure of rheumatoid arthritis although Unani system of
medicine provide a number of single as well as compound formulations which are
in use since ancient time but these formulations have to be evaluated on
scientific parameters in order to generate data regarding their safety and
efficacy.Therefore, the present clinical study has been planned to evaluate the
safety and efficacy of Qurs-e-Mafasilin
the treatment of Waja‘al-MafÄá¹£il (Rheumatoid arthritis). |