MedPath

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

Phase 2
Completed
Registration Number
CTRI/2010/091/002808
Lead Sponsor
KP Salve Institute of Medical Sciences & Research Centre and Lata Mangeshkar Hospital for the trial.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
59
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
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1.Subjects were to be withdrawn from the study for the following reasons: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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath