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Clinical study on Habb-e-Asgand in the management of Rheumatoid Arthritis

Phase 2
Not yet recruiting
Conditions
Rheumatoid arthritis with rheumatoid factor without organ or systems involvement,
Registration Number
CTRI/2022/01/039602
Lead Sponsor
Central Council for Research in Unani Medicine
Brief Summary

Rheumatoid Arthritis (Waja-ul-Mafasil) is a common,immune-mediated disease characterized by chronically progressive inflammationand destruction of joints and associated structures as well as systemicsymptoms .Rheumatoid arthritis is one of the most commondiseases in India. The population prevalence of rheumatoid arthritis in Indiais 0.75%. It was estimated that 9 million people could be affected with Rheumatoidarthritis.

Peak incidence are in 3rd to 4th decades oflife, with 3-5 times higher preponderance in females. The onset of the diseaseis insidious, beginning with prodrome of fatigue, weakness, joint stiffness,vague arthralgias and myalgias. This is followed by pain and swelling of jointsusually in symmetrical fashion, especially involving joints of hands, wrist andfeet. Approximately 20% of patients develop rheumatoid nodules located over theextensor surfaces of the elbows and fingers.

The mortality rate is higher amongpatients with RA than among healthy persons, and cardiovascular and othersystemic complication remain a major challenge.

Current therapy has a goal ofcomplete and long-lasting remission but, typically, only partial remission isachieved and frequent relapses or even non-response are common.

Conventional treatments for RA, includingnon steroidal anti-inflammatory drugs (NSAIDs), slow-acting anti-rheumaticdrugs and corticosteroids, aim to reduce the patients’ pain and jointinflammation, minimize loss of function and decrease the progression of jointdamage. However, such treatments are rarely totally effective and somepharmacological therapies have the potential to cause side-effects, such asgastro-intestinal bleeding and bone loss.**5** As a result manyRA sufferers turn to alternative therapies including *Unani* system ofmedicine. *Habb-e-Asgand* is an important Unani pharmacopoeialformulation which is commonly prescribed for *W**aja-ul-Mafasil*(Arthritis) and *Waja-ul-Warik* (Lumbago) due to its *Muhallil-e-Waram*(anti-inflammatory)action**.6,7**Hence, the need arise to validate the action ofthis compound in the management of *Waja-ul-mafasil* (Rheumatoidarthritis) keeping in view the line of treatment *Waja-ul-mafasil Balgami*(phelgmatic arthritis).The current study is therefore designed to investigatethe effect of  *Habb-e-Asgand* in *Waja-ul-mafasil*(Rheumatoid Arthritis).

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
40
Inclusion Criteria
  • 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.
Exclusion Criteria
  • Uncontrolled Diabetes mellitus.
  • Hepatic or Renal insufficiency.
  • Other type of arthritis.
  • Pregnancy and lactation.
  • Any joint surgery in the previous 6 months 6.
  • Patients with cardiovascular diseases.
  • Patients who refuse to give the written consent for the study.
  • Severe cases of Rheumatoid Arthritis.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Relief in signs and symptoms of Rheumatoid arthritis45 days
Secondary Outcome Measures
NameTimeMethod
Haematological, Radiological and Biochemical assessment45 days

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 Uzma Rehman
Principal investigator
07982172022
ruzma530@gmail.com

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