To Study the effect of Unani Compound Formulation in patients with Wajaâ€˜al-Mafasil (Rheumatoid Arthritis)

Phase 2

Not yet recruiting

Conditions: Rheumatoid arthritis with rheumatoid factor, (2) ICD-10 Condition: M057||Rheumatoid arthritis with rheumatoid factor without organ or systems involvement,

Registration Number: CTRI/2022/01/039486

Lead Sponsor: Central Council for Research in Unani Medicine New Delhi

Brief Summary: Rheumatoid arthritis is a chronic inflammatory autoimmune disease of unknown etiology characterized by symmetric polyarthritis. The hallmark of persistently active rheumatoid arthritis is that it often results in articular cartilage damage, bone destruction, and functional disability. The prevalence of this disease is approximately 0.8â€“1.0% in Europe and the Indian subcontinent, with a female-to-male ratio of 3:1. In India, the prevalence of this disease is 0.5% to 0.75%.It is said that one in 12 women and one in 20 men will develop rheumatoid arthritis during their lifetime. Etiology of rheumatoid arthritis remains elusive although it appears that genetics, immunological derangement, infections, environmental and hormonal factors (In females) are all involved in the complex . This disease affects people between 25 and 55 years of age, after which it plateaus until the age of 75 and then decreases. The typical presentation of rheumatoid arthritis is pain, inflammation of joints, tendons and bursae, joint swelling, tenderness, and early morning stiffness lasting more than one hour that eases with physical activity, associated with constitutional symptoms of fatigue, malaise, loss of appetite and weight loss. It is a systemic disorder, thus may also lead to a variety of extra-articular manifestations .

In the Unani system of medicine it is not mentioned under the heading of Rheumatoid Arthritis but the disease has been vividly described by various Unani physicians under a generalized term *Wajaâ€˜al-Mafasil*. The causes of rheumatoid arthritis described in modern medicine are different from the causes explained in the Unani system of medicine. The conventional medications used for the treatment of this disease may be divided into broad categories: non steroidal anti-inflammatory drugs; gluco-corticoids, conventional disease modifying antirheumatic drugs including Hydroxychloroquine, Sulfasalazine, and Methotrexate; and biologic disease modifying antirheumatic drugs. However, they are frequently associated with a fair degree of moderate to severe side effects including gastritis, peptic ulcer disease, renal function impairment in case of non steroidal anti-inflammatory drugs and corticosteroids, nausea, diarrhea, headache, rashes, cardiotoxicity, blood dyscrasia, irreversible retinal damage, hepatotoxicity, neurological deficit, granulocytopenia, hemolytic anemia, myelo-suppression in case of disease modifying antirheumatic drugs.Thus there is a gross requirement for alternative treatment. The Unani compound formulation containing *Suranjan Talkh* (*Colchicum luteum* Baker), *Zanjabeel* (*Zingiber officinale* Rosc.)and *Aelva* (*Aloe barbadensis* Mill.) is mentioned to be used in *Wajaâ€˜al*-*MafÄá¹£il* in the *Bayaz-e-Khass* of *Hakeem Sharief Khan.*The principle of treatment aims at restoring the normal temperament and correcting the imbalance in the *Khilá¹* (humour) through *ImÄla* (Diversion of morbid material) and *IstifrÄgh* (Evacuation of morbid material). Significant anti-arthritic activity of this Unani pharmacopoeial formulation has been studied in albino rats. Thus in order to provide safe and more effective treatment for rheumatoid arthiritis the present study entitled "Clinical Study of *Wajaâ€˜al-MafÄá¹£il* (Rheumatoid Arthritis) with Therapeutic Efficacy Evaluation of Unani Compound Formulation in its Managementâ€ is designed.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 42

Inclusion Criteria

1.Patients irrespective of gender will be selected for the study.
2.Patients in the age group of 18 to 65 years fulfilling the criteria of the New American College of Rheumatology-European League Against Rheumatism 2010 for the diagnosis of rheumatoid arthritis.
3.Patients, who are ready to sign the informed consent, follow the protocol and willing to participate in the clinical study voluntarily.
4.Patients with features of preclinical rheumatoid arthritis, established rheumatoid arthritis and presence of active disease will be included in the study.

Exclusion Criteria

1.Patients below 18 years and above 65 years of age.
2.Patients who fail to follow up.
3.Patients who fail to give written consent.
4.Women who are pregnant, planning pregnancy, or breast feeding.
5.Patients having other types of arthritis.
6.Patients with the history of any systemic illness like uncontrolled diabetes, malignant hypertension, cardiovascular diseases, severe blood disorders and impaired renal function or patient with any other severe chronic or acute disease interfering with attendance for therapy.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain intensity, Swollen joint count, Morning stiffness and Fatigue.The Data for these subjective parameters will be recorded on 0,7th,15th,30th and 45th day.	45 Days

Secondary Outcome Measures

Name	Time	Method
DAS 28 (Disease Activity Score),DAS 28-CRP,Erythrocyte Sedimentation Rate (ESR),Quantitative C -reactive protein (CRP),Quantitative Rheumatoid factor (RF) ,Quantitative Anti-citrullinated protein antibody (ACPA/Anti-CCP),and Interleukin 6(IL-6).The data for these objective parameters including serum biomarkers will be recorded on 0th and 46th day of the study.The ECG, Haematological and Biochemical assessment will be done before and after the study in view of safety evaluation.	The Data for remaining objective parameters i.e.Tender joint count and HAQ disability index score will be recorded on 0,7th,15th,30th and 45th day.

Trial Locations

Locations (1): Regional Research Institute of Unani Medicine (RRIUM)
🇮🇳
JAMMU, & KASHMIR, India
Regional Research Institute of Unani Medicine (RRIUM)
🇮🇳JAMMU, & KASHMIR, India
Dr Atiba Jan
Principal investigator
7889431573
aatibajan124@gmail.com