role of Dazzle capsule in Rheumatoid arthritis

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2016/01/006572
• Date of registration: 28-01-2016
• Prospective Registration: No
• Primary sponsor: Vasu Research Centre
• Public title: role of Dazzle capsule in Rheumatoid arthritis
• Scientific title: EVALUATION OF CLINICAL EFFICACY & SAFETY OF DAZZLE CAPSULE IN THE MANAGEMENT OF RHEUMATOID ARTHRITIS (AMAVATA)
• Date of first enrolment: 16-10-2014
• Target sample size: 60
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=8831
• Study type: Interventional
• Study design: Single Arm Trial; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
• Phase: Post Marketing Surveillance

Countries of recruitment

India

Contacts

• Name: Mandip Goyal
• Affiliation: Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar

• Name: Shruti Joshi
• Affiliation: Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar

Key inclusion & exclusion criteria

Inclusion criteria: Presence of any four out of the following seven (Joneâ??s) criteria (according to 1987, revised criteria of American College of Rheumatology)

a. Morning stiffness: Stiffness in and around joints lasting one hour before maximal improvement (More than 6 weekâ??s duration).

b. Arthritis of three or more joints, at least three joint area, observed by scholar, having pain with soft tissue swelling or joint effusion, not just bony over growth, (more than 6 weeks duration).

c. Arthritis of hand joints, at least 1 area in wrist and hand is swollen (more than 6 weeks duration).

d. Symmetric arthritis (more than 6 weekâ??s duration).

e. Presence of Rheumatoid Nodules

f. Serum Rheumatoid factor- positive

g. Typical radiographic changes of arthritis on PA view of hand & wrist radiograph that must include erosions or unequivocal bony decalcification, localized in or adjacent to involved joints.


Exclusion criteria: Patients who have developed complications of Rheumatoid Arthritis e.g. severe deformity of joints / bones, pleura-pericardial disease, or else.

(2) Patients with poorly controlled Hypertension or with uncontrolled Diabetes Mellitus and having a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.

(4) Patients on prolonged medication with corticosteroids, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study.

(5) H/o hypersensitivity to any of the trial drugs or their ingredients.

(6) Pregnant/lactating women.

(7) Patients having chronicity >10 years





Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Rheumatoid arthritis

Intervention(s)

Intervention1: DAZZLE CAPSULE: 2 capsule twice a day each of 500 mg after meal with Warm water for three months

Control Intervention1: Nil: Nil

Primary Outcome(s)

To assess the clinical efficacy and safety of Dazzle Capsule in the management of Rheumatoid Arthritis (Amavata)Timepoint: 3months

Secondary Outcome(s)

To assess the symptomatic improvement by Dazzle Capsule in the management of Rheumatoid Arthritis (Amavata)Timepoint: 3months

Secondary ID(s)

NIL

Source(s) of Monetary Support

Vasu Research Centre A Division of VASU Health Care Pvt Ltd 896/A G.I.D.C. Makarpura Vadodara- 390010

Ethics review

Status: Approved
Approval date: 09/12/2013
Contact:

Institutional Ethics Committee