| CTRI Number |
CTRI/2020/10/028663 [Registered on: 27/10/2020] Trial Registered Prospectively |
| Last Modified On: |
22/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to compare the effect of extract and crude form of Unani drug in the treatment of Gouty Arthritis. |
|
Scientific Title of Study
|
A clinical study on the comparative assessment in the treatment of Gouty Arthritis (Niqris) with extract and crude form of the Unani polyherbal formulation, a randomized 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 |
Dr Nasir Jamal |
| Designation |
MD student |
| Affiliation |
Ayurvedic and Unani Tibbia College Hospital |
| Address |
Department of Moalijat, OPD no.04, Ayurvedic and Unani Tibbia College Hospital, Ajmal Khan Road, Karol Bagh
Central
DELHI
110005
India |
| Phone |
8800807510 |
| Fax |
|
| Email |
naasirjamaal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rais Ur Rahman |
| Designation |
Professor and Supervisor |
| Affiliation |
Ayurvedic and Unani Tibbia College Hospital |
| Address |
Department of Moalijat, OPD no.04, Ayurvedic and Unani Tibbia College Hospital, Ajmal Khan Road, Karol Bagh
Central
DELHI
110005
India |
| Phone |
9313980776 |
| Fax |
|
| Email |
drrahman002@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nasir Jamal |
| Designation |
MD student |
| Affiliation |
Ayurvedic and Unani Tibbia College Hospital |
| Address |
Department of Moalijat, OPD no.04, Ayurvedic and Unani Tibbia College Hospital, Ajmal Khan Road, Karol Bagh
Central
DELHI
110005
India |
| Phone |
8800807510 |
| Fax |
|
| Email |
naasirjamaal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurvedic and Unani Tibbia College Hospital, Karol Bagh, New Delhi 110005 |
|
|
Primary Sponsor
|
| Name |
Ayurvedic and Unani Tibbia College Hospital |
| Address |
Ayurvedic and Unani Tibbia College Hospital |
| 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 Nasir Jamal |
Ayurvedic and Unani Tibbia College Hospital |
Department of Moalijat,Ayurvedic and Unani Tibbia College Hospital, Ajmal Khan Road, Karol Bagh
Central
DELHI |
8800807510
naasirjamaal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ayurvedic and Unani Tibbia College Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M109||Gout, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Extract
of Unani polyherbal formulation {Suranjan talkh (Colchicum luteum),Elva (Aloa barbadensis),Qurtum (Carthamus tinctorious),Halaila-e-zard (Terminalia chebula),Zanjabeel (Zingiber officinalis)} filled in
capsule form |
1 Capsule of 300mg twice a day orally for 6 weeks. |
| Comparator Agent |
Crude Powder of Unani polyherbal formulation {Suranjan talkh (Colchicum luteum),Elva (Aloa barbadensis),Qurtum (Carthamus tinctorious),Halaila-e-zard (Terminalia chebula),Zanjabeel (Zingiber officinalis)} filled in a capsule form |
2 Capsules of 1 gram each, thrice a day orally for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient with clinical features of gouty arthritis, Serum uric acid more than 7 mg/dL, Patient willing to discontinue the drugs taking for the treatment of gouty arthritis, Patient willing to participate in the study and sign the informed consent form |
|
| ExclusionCriteria |
| Details |
Patient having Gouty arthritis with its complications such as Tophi and renal stones etc, Pregnant and lactating women, Patient receiving Uric acid elevating drugs eg, Pyrazinamide, Thiazide group of diuretics / Aspirin / NSAIDs and Anti-gouty drugs, Renal insufficiency, Hepatic insufficiency, Cardiovascular disorders, Haemopoietic disorders, Patient suffering from malignancy, taking chemo and radiotherapy |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Serum uric acid and pain (Wong Baker’s Faces rating scale 0-10) will be assesed |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Tenderness, joints sweelling, joints movement,CRP, ESR will be assesed |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
02/11/2020 |
| Date of Study Completion (India) |
17/05/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
17/05/2021 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized, parallel group trial to evaluate the efficacy and safety of the extract form of the Unani polyherbal formulation in
reducing hyperuricemia and its manifestations by using modern parameters and to compare its efficacy with crude form of same Unani
Polyherbal Formulation. The individuals affected with gout are at increased risk of Hypertension, Diabetes Mellitus, Metabolic
Syndrome, Kidney and Cardiovascular disorders and thus are at increased risk of death. Due to these
complications, Gout has become a distressing problem, despite advancement of modern science.
Several agents are already being used such as NSAIDs (Indomethacin, Ibuprofen etc), Colchicine,
Xanthine oxidase inhibitors (Allopurenol, Febuxostat etc) , but long term use of these drugs lead to
development of various side effects like, gastrointestinal upset, GI bleeding, skin rashes, anaemia,
vomiting, diarrhoea, kidney damage, Stevens-Jonsons syndrome, peripheral neuritis etc. Therefore
search for safe and effective drug is the need of the time especially from herbal source. Unani scholars
have described Principles of treatment for management of gout and many safe and effective single as
well as compound drugs in classical Unani literature for the same purpose. In the recent past, two
studies have been conducted in the Moalijat department of A & U Tibbia Hospital and the results of
the studies were found very encouraging. i.e:
1. A Placebo control study, conducted in 2008 under supervision of Prof. Rais-ur-Rahman on
gouty arthritis resulting in more than 80% of efficacy.
2. A standard control study, done in 2012 in which allopurinol was taken as standard control with
more than 80% efficacy in gouty arthritis.
In both the studies, the same unani polyherbal formulation was given in crude (powder) form. In the
current study, we are planning to use extract form of the same Unani Polyherbal
formulation to compare the effectiveness between powder and extract form. |