| CTRI Number |
CTRI/2024/02/062472 [Registered on: 09/02/2024] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To evaluate the safety and effectiveness of Unani formulation namely Safuf-e-Chobchini in patients with Rheumatoid arthritis. |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the Safety and Therapeutic
Efficacy of Safuf-e-Chobchini in the Management of Waja-al-Mafasil (Rheumatoid Arthritis); A Block Randomised,Open label,Standard Control Study.
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Zaffar Hussain |
| Designation |
Professor and HOD, Department of Moalajat |
| Affiliation |
Regional Research Institute of Unani Medicine (RRIUM) , Srinagar |
| Address |
Department of Moalajat, Regional Research Institute of Unani Medicine(RRIUM), Nasim Bagh campus of University of Kashmir, Srinagar, Jammu and Kashmir 190006
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
7006021996 |
| Fax |
|
| Email |
hussainzaffar6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Zaffar Hussain |
| Designation |
Professor and HOD, Department of Moalajat |
| Affiliation |
Regional Research Institute of Unani Medicine (RRIUM) , Srinagar |
| Address |
Department of Moalajat, Regional Research Institute of Unani Medicine(RRIUM), Nasim Bagh campus of University of Kashmir, Srinagar, Jammu and Kashmir 190006
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
7006021996 |
| Fax |
|
| Email |
hussainzaffar6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abhar Qureshi |
| Designation |
PG scholar |
| Affiliation |
Regional Research Institute of Unani Medicine (RRIUM) , Srinagar |
| Address |
Department of Moalajat, Regional Research Institute of Unani Medicine(RRIUM), Nasim Bagh campus of University of Kashmir, Srinagar, Jammu and Kashmir 190006
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
9018408955 |
| Fax |
|
| Email |
qureshiabhar99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council of Research in Unani Medicine, New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine , New Delhi |
| Address |
Regional Research Institute of Unani Medicine(RRIUM),University of Kashmir, Srinagar;CCRUM, New Delhi |
| 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 Abhar Qureshi |
Regional Research Institute of Unani Medicine |
Moalajat OPD-1,
Ground floor,
Department of Moalajat,
RRIUM, Naseembagh
Campus University of
Kashmir Hazratbal
Srinagar
JAMMU & KASHMIR
Srinagar
JAMMU & KASHMIR |
9018408955
qureshiabhar99@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: M059||Rheumatoid arthritis with rheumatoid factor, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Safuf-e-Chobchini |
The unani formulation Safuf-e-Chobchini is a unani pharmacopeial formulation commonly prescribed for waja-al-mufasil(arthritis).It contains eight herbal drugs namely
Ushba-e-Maghrabi (Smilax aristolochifolia),Chobchini (Smilax china L.),Gul-e surkh (Rosa damascena Mill.),Barg-e sana (Cassia angustifolia Vahl),Suranjan Sheeren (Merendra persica), Sandal sufaid (Santalum album L.),Bisfaij fistaqui (Polypodium vulgare),Aftimoon (Cuscuta reflexa Roxb.)
The formulation shall be given 3mg twice a day for 6 weeks
|
| Comparator Agent |
Sulfasalazine |
Sulfasalazine 500mg to be given twice daily for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients in the age group of 18 to 65 years.
2.Patients irrespective of gender.
3.Patients who fulfill the criteria of the New American College of Rheumatology European League Against Rheumatism 2010 for the diagnosis of rheumatoid arthritis.
4. Patients, who are ready to sign the informed consent, follow the protocol and willing to participate in the clinical study voluntarily.
|
|
| ExclusionCriteria |
| Details |
1.Women who are pregnant, planning pregnancy, or breast feeding.
2.Patients with systemic,extra-articular manifestations of rheumatoid arthritis.
3.Patients having gouty arthritis and psoriatic arthritis.
4.Patients with history of systemic disease like uncontrolled diabetes mellitus and hypertension,hepatic dysfunction and impaired renal function.
5.Patients currently receiving or have received intra-articular treatment, oral or parenteral corticosteroids, or NSAIDs within 2 weeks, DMARDs or anticipated IFN therapy within 4 weeks prior to study entry.
6.Obese subjects with BMI ≥35
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Pain intensity
2. Joint swelling
3. Morning stiffness
4. Fatigue
5. Restricted movement of joints
6. Joint tenderness |
Day 0,Day 14, Day 28,Day 42 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.DAS 28
2.HAQ disability index score
3.Erythrocyte sedimentation rate (ESR)
4. Quantitative C -reactive protein (CRP)
5. Quantitative Rheumatoid factor (RF)
6.Quantitative Anti-citrullinated protein antibody (ACPA)
7. Interleukin 6 (IL-6)
|
Day 0,Day 43 |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "64"
Final Enrollment numbers achieved (India)="64" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/02/2024 |
| Date of Study Completion (India) |
29/12/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
29/12/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Rheumatoid arthritis is a chronic, systemic inflammatory disease of unknown etiology that primarily targets synovial tissue.Rheumatoid arthritis is a global disease with a variable geographic prevalence of 0.5% to 1% adults.The incidence of rheumatoid arthritis increases between 25 and 55 years of age, after which it plateaus until the age of 75 and then decreases.The disease may be insidious in nature rarely occurring in men younger than 30 years with gradually rising incidence with advancing age. In women the incidence steadily increases from mid 20s to peak incidence between 45 to 75 years. Rheumatoid arthritis occurs more commonly in females than in males, with a 2-3:1 ratio. It has been recognised that genetic factors contribute to occurrence of rheumatoid arthritis.Increasing evidence supports a substantial role for environmental factors including smoking,other pulmonary exposures (silica), obesity, vitamin D deficiency as enhancing factors for rheumatoid arthritis risk. The primary target tissue is the inflamed synovium that contains a range of activated leucocytes and stromal cells that under the influence of inflammatory cytokines drive local cartilage and bone destruction. Patient often complains of early morning joint stiffness lasting more than 1 hour that eases with physical activity.The earliest involved joints are typically the small joints of the hands and feet. In Unani system of medicine, Rheumatoid arthritis comes under the heading of “Waja-al-Mufasil†and “ghatiyaâ€.The cause of this disease is believed to be derangement of temperament (soo-e-mizaj.The management of rheumatoid arthritis has continued to improve globally, where early use of conventional and biologic disease modifying antirheumatic drugs (DMARDs) have dramatically improved patient outcome ;however ,a sizeable proportion of patients do not respond adequately to treatment. In addition, these powerful drugs are often associated with unpleasant side effects and occasionally serious adverse events. Furthermost ,the high cost of biological drugs has hindered their accessibility .For these reasons rheumatoid arthritis patients are increasingly seeking complimentary and alternative medicinesâ¶.The unani formulation Sufuf-eChobchini is a unani pharmacopeial formulation commonly prescribed for waja’almufasil(arthritis).It contains eight herbal drugs namely Ushba-e-Maghrabi (Smilax aristolochifolia),Chobchini (Smilax china L.),Gul-e surkh(Rosa damascena Mill.),Barg-e sana (Cassia angustifolia Vahl),Suranjan Sheeren (Merendra persica), Sandal sufaid (Santalum album L.),Bisfaij fistaqui (Polypodium vulgare),Aftimoon (Cuscuta reflexa Roxb.). These ingredients are reported to have anti inflammatory, analgesic,phelgemogue and purgative activities . Even though this formulation has been used in the unani system of medicine for years,its efficacy in rheumatoid arthritis has not been validated using modern scientific parameters |