A Comparative clinical Study to Evaluate the Efficacy and Safety of â??Herbal Extract(Bonfend Tablets)â?? to prevent Steroid Induced Osteoporotic Changes in Patients with Rheumatoid Arthritis.
- Conditions
- Health Condition 1: M818- Other osteoporosis without currentpathological fracture
- Registration Number
- CTRI/2020/04/024918
- Lead Sponsor
- Pharmanza herbal Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Willing and able to provide written informed consent and comply with the requirements of the study protocol.
2. Adult subjects of either gender in age group of 18 â?? 65 years.
3. History of rheumatoid arthritis, as defined by American College of Rheumatology (ACR) Classification 1for at least 3-6 months and who are about to be started on steroids for the first time.
4. If female and of childbearing potential, she shall have a negative pregnancy test at the time of screening and agrees to use adequate contraception throughout the study period.
5. No history of addiction to any recreational drug or drug
dependence.
1.Hypersensitivity to any of the components of Herbal Tablet or the excipients of the formulation.
2.Current treatment with NSAID, DMARD (the investigator for
his opinion) or any tumor necrosis factor (TNF) inhibitors or
other anti-arthritic therapy within 2 weeks prior to
randomization.
3. Major surgical procedure within 28 days prior to randomization.
4.Difficulty in swallowing and retaining oral formulation.
5. Any condition that in opinion of the Investigator, does not justify
the subjectsâ?? participation in the study.
6.Patients with significant systemic manifestation of RA.
7.Female nursing patients.
8.Rheumatic autoimmune disease other than RA.
9.History of diagnosis of juvenile idiopathic arthritis (JIA) (also
known as juvenile rheumatoid arthritis [JRA]) and/or RA before
age 16.
10.History of inflammatory arthritis other than RA (e.g.
Inflammatory bowel disease (IBD), systemic lupus
erythematosus (SLE) or psoriatic arthritis).
11.Functional Class IV as defined by the American College of
Rheumatology (ACR) classification of functional status in RA2.
12.Use of intra-articular or parenteral corticosteroids within 4
weeks prior to screening visit. Inhaled corticosteroids for stable
medical conditions are allowed.
13.Receipt of vaccine within 4 weeks prior to enrollment visit.
14.History of primary or secondary immunodeficiency.
Evidence of significant uncontrolled concomitant diseases such
as cardiovascular disease, nervous system, renal, hepatic,
endocrine, gastrointestinal, or pulmonary disease, including any
pulmonary or other condition that would preclude subject
participation.
15.Known active bacterial, viral, fungal, mycobacterial, or other
infection (including tuberculosis or atypical mycobacterial
disease but excluding fungal infections of nail beds).
16.History of travel to areas endemic for mycoses, such as
histoplasmosis, coccidioidomycosis or blastomycosis
17.History of recurrent significant infection or any significant
episode of infection requiring hospitalization or treatment with
IV antibiotics within 4 weeks of screening oral antibiotics within
2 weeks prior to screening
18.History of cancer, including solid tumors and hematologic
malignancies (except basal cell and squamous cell carcinoma of
the skin that have been excised and cured).
19. Lack of peripheral venous access.
20.History of chronic daily use of narcotic analgesics.
21.History of alcohol, drug, or chemical abuse within 6 months
prior to screening.
22.Positive history of Hepatitis B surface antigen or antibodies to
Hepatitis C.
23.History of significant cytopeniaâ??s or other bone marrow
disorder.
24.Laboratory exclusion criteria: Patients may not participate in this
study until any of the following that are present have resolved.
a. Serum creatinine > 1.4 mg/dL for women or 1.6 mg/dL for
men.
b. AST or ALT > 2.5 times upper limit of normal (UNL)
c. Neutrophil < 1.5 x 103/μL
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method