| CTRI Number |
CTRI/2022/01/039602 [Registered on: 20/01/2022] Trial Registered Prospectively |
| Last Modified On: |
19/01/2022 |
| 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
|
Clinical study on Habb-e-Asgand in the management of Rheumatoid Arthritis |
|
Scientific Title of Study
|
To Evaluate the therapeutic efficacy of Habb-e-Asgand in the management of Waja-ul-Mafasil(Rheumatoid Arthritis).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 |
Uzma Rehman |
| Designation |
PG scholar |
| Affiliation |
Regional Research Institute of Unani Medicine, Srinagar |
| Address |
Department of Moalajat, Regional Research Institute of Unani Medicine, Naseem Bagh ,Kashmir University , Srinagar
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
7982172022 |
| Fax |
|
| Email |
ruzma530@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Zaffar Hussain |
| Designation |
Professor Department of Moalajat |
| Affiliation |
Regional Research Institute of Unani Medicine, Srinagar |
| Address |
Department of Moalajat, Regional Research Institute of Unani Medicine, Naseem Bagh ,Kashmir University , Srinagar
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
7006021996 |
| Fax |
|
| Email |
hussainzaffar6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Zaffar Hussain |
| Designation |
Professor Department of Moalajat |
| Affiliation |
Regional Research Institute of Unani Medicine, Srinagar |
| Address |
Department of Moalajat, Regional Research Institute of Unani Medicine, Naseem Bagh ,Kashmir University , Srinagar
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
7006021996 |
| Fax |
|
| Email |
hussainzaffar6@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Unani Medicine, New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine |
| Address |
61-65, Institutional Area, Opp. D-Block, Janakpuri , New Delhi 110058 |
| Type of Sponsor |
Research institution |
|
|
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 Uzma Rehman |
Regional Research Institute of Unani Medicine (RRIUM) |
Moalajat OPD-1, Ground Floor , Department of Moalajat, RRIUM,Kashmir University ,Naseem Bagh
Srinagar
JAMMU & KASHMIR |
07982172022
ruzma530@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, RRIUM, Srinagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M057||Rheumatoid arthritis with rheumatoid factor without organ or systems involvement, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Sulfasalazine |
Sulfasalazine 500 mg twice daily orally with water after meal for 45 days |
| Intervention |
Habb-e-Asgand (Pills) |
Ajwayin Desi(20g), Asgand(40g), Bidhara(40g), Bidhara(40g), Peepla Mool(20g), Pipal kalan(20g), Zanjabeel(40g), Satawar(40g), Musli siyah(20g) all are grounded to fine powder and mixed with Gur (50g) to form pills of size 650mg.Two pills orally at bed time daily , for 45days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Clinically diagnosed /or serological evidence of Rheumatoid arthritis(Waja-ul-Mafasil). 2 Patients who have agreed to sign the informed consent, follow the protocol and willing to participate in clinical trial voluntarily.3 Mild to Moderate cases of Rheumatoid Arthritis.4 Have a diagnosis of Rheumatoid Arthritis (RA) as defined by American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR)2010 Criteria for the Classification of RA. |
|
| ExclusionCriteria |
| Details |
1. Uncontrolled Diabetes mellitus.
2. Hepatic or Renal insufficiency.
3. Other type of arthritis.
4. Pregnancy and lactation.
5. Any joint surgery in the previous 6 months
6. Patients with cardiovascular diseases.
7. Patients who refuse to give the written
consent for the study.
8. Severe cases of Rheumatoid Arthritis
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in signs and symptoms of Rheumatoid arthritis |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological, Radiological and Biochemical assessment |
45 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)
|
28/01/2022 |
| 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="0"
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)?
Response - NO
|
|
Brief Summary
|
Rheumatoid Arthritis (Waja-ul-Mafasil) is a common,
immune-mediated disease characterized by chronically progressive inflammation
and destruction of joints and associated structures as well as systemic
symptoms . Rheumatoid arthritis is one of the most common
diseases in India. The population prevalence of rheumatoid arthritis in India
is 0.75%. It was estimated that 9 million people could be affected with Rheumatoid
arthritis.
Peak incidence are in 3rd to 4th decades of
life, with 3-5 times higher preponderance in females. The onset of the disease
is insidious, beginning with prodrome of fatigue, weakness, joint stiffness,
vague arthralgias and myalgias. This is followed by pain and swelling of joints
usually in symmetrical fashion, especially involving joints of hands, wrist and
feet. Approximately 20% of patients develop rheumatoid nodules located over the
extensor surfaces of the elbows and fingers.
The mortality rate is higher among
patients with RA than among healthy persons, and cardiovascular and other
systemic complication remain a major challenge.
Current therapy has a goal of
complete and long-lasting remission but, typically, only partial remission is
achieved and frequent relapses or even non-response are common.
Conventional treatments for RA, including
non steroidal anti-inflammatory drugs (NSAIDs), slow-acting anti-rheumatic
drugs and corticosteroids, aim to reduce the patients’ pain and joint
inflammation, minimize loss of function and decrease the progression of joint
damage. However, such treatments are rarely totally effective and some
pharmacological therapies have the potential to cause side-effects, such as
gastro-intestinal bleeding and bone loss.5 As a result many
RA sufferers turn to alternative therapies including Unani system of
medicine. Habb-e-Asgand is an important Unani pharmacopoeial
formulation which is commonly prescribed for Waja-ul-Mafasil
(Arthritis) and Waja-ul-Warik (Lumbago) due to its Muhallil-e-Waram(anti-inflammatory)
action.6,7Hence, the need arise to validate the action of
this compound in the management of Waja-ul-mafasil (Rheumatoid
arthritis) keeping in view the line of treatment Waja-ul-mafasil Balgami
(phelgmatic arthritis).The current study is therefore designed to investigate
the effect of Habb-e-Asgand in Waja-ul-mafasil
(Rheumatoid Arthritis). |