A clinical trial to study the Effect of Helicobacter pylori bacterial infection removal therapy on the patients of Rheumatoid Arthritis (joint pain).

Effect of Helicobacter pylori eradication therapy on the outcome of Rheumatoid Arthritis.

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/002808

Enrollment

Registered

2010-12-22

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: NSAID (Nebumetone): 500mg/day Intervention2: Methotrexate: 2.5 mg twice/week Intervention3: Hydroxychloroquine: 300mg/day Intervention4: Sulfasalazine: 1-2gms/day Intervention5: Prednis

#8260

day Intervention6: Lactitol with probiotics: 20 gm Lactitol Monohydrate granules) 1 BD for 7 days with Cap Probiotic (Darolac, Aristo pharmaceutical Ltd containing Lactobacillus acidophilus, Lactobaci

Saccharomyces boulardii 2.5 billion spores) 1 BD for 7 days. Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Criteria: 1. Patients of either sex, between 18-65 years of age. 2. Clinically diagnosed Rheumatoid Arthritis patient by American Rheumatism Association, 1987 revised criteria for Classification of Rheumatoid Arthritis. 3. Patient willing for C14-Urea Breath Test (using Heliprobe system of Kibion, Sweden).

Exclusion criteria

Exclusion criteria: Exclusion Criteria 1. Patients with history of Ischemic Heart Disease, Gastro-intestinal tract surgery. 2. Patients with history of Surgical Synovectomy. 3. Known patients with duodenal or gastric ulcer or carcinoma stomach. Pregnancy. 4. Patients with severe cardio-pulmonary disease, chronic renal failure or presence of joint destruction suggesting a serious disease. Withdrawal Criteria 1. Subjects were to be withdrawn from the study for the following reasons: 2. At the request of the subject. 3. The investigators consider that a subject?s health was compromised because of an adverse effects or experience or concomitant illness that develops after entering the study. 4. Patient not tolerating Lactitol and Lactic acid bacillus therapy.

Design outcomes

Primary

Measure	Time frame
health assessment questionnaires 68 painful/tender joint index 66 swollen joint index duration of morning stiffness hand grip strength in right & left hand ESR CRP.Timepoint: baseline(0 month) and at interval of 1½ ,4, 7 and 10 months	—

Secondary

Measure	Time frame
serum creatinine and SGPT for safety parameterTimepoint: at baseline and at interval of 1½ ,4, 7 and 10 months	—

Countries

India

Contacts

Public ContactDR. DIXIT K. PATEL

NKP Salve Institute of Medical Sciences & Research Centre and Lata Mangeshkar Hospital, Digdoh hill, Hingna road Nagpur.

dr.dixitpatel@gmail.com.07104236290

Outcome results