None listed
Conditions
Interventions
Intervention1: Colchicum LM: The patient is instructed to take one teaspoon from the bottle twice a day
Intervention2: Colchicum 30 C: The patient is instructed to take one teaspoon from the bottle tw
Sponsors
NVS BIO RESEARCH PVT.LTD
Address: 19, Gokul Mitra Lane, Kolkata-700005. West Bengal, India.
Regd. Off.: Bazigaran Street, Moradabad, Pin: 244001, U.P, India
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria for previously diagnosed patients not in an acute episode at the time of recruitment10: 1. Ages 18 and older. 2. Per Terkeltaub et al (2009), 6 confirmed past diagnosis of gout using American Rheumatology Classification criteria and history of at least 2 gout flares within the prior 12 months. 3. Willingness to return at onset of an acute gouty arthritis flare. Inclusion Criteria for patients recruited at onset of an acute gouty arthritis flare: 1. An acute gout onset within the previous 48 hours (both sexes allowed, but sample is expected to be mostly middle-aged and older men; among women, postmenopausal status). Inclusion Criteria for all patients either recruited at onset or returning at onset of an episode 1. Acute gout clinical diagnosis, i.e., meeting criterion A, B, or C: (Adapted from the 1980 American Rheumatology Association criteria for the classification of acute arthritis of primary gout18). a. The presence of characteristic urate crystals in the joint fluid (if at past attack then C1 and C4 also). b. A tophus proved to contain urate crystals by chemical means or polarised light microscope and C1 and C4. c. Presence of six of the following 12 clinical, laboratory, and radiographic phenomena: 1. Maximum inflammation developed within one day 2. More than one attack of acute arthritis 3. Presents with monoarticular arthritis 4. Redness is observed over the affected joint(s) 5. First metatarsophalangeal pain or swelling 6. Unilateral first metatarsophalangeal joint attack 7. Unilateral tarsal joint attack 8. Tophus is suspected 9. Hyperuricaemia 10. Asymmetric swelling within a joint 11. Subcortical cysts without erosions in radiograph 12. Joint fluid culture negative for organisms 2. Number of affected joints= 1 (may be stratified for monoarticular vs. polyarticular for data analysis in larger study). 3. Vital signs and clinical lab test findings for blood levels of uric acid, CBC, ESR, C-reactive protein, and renal function as well as urinalysis at the current episode, to ensure patient is a candidate for indometicin rescue drugs and has no other acute problems. 4. If taking chronic medications such as a urate-lowering drug like allopurinol, stable for at least 3 months prior to enrollment.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1. Polyarticular gout i.e., affecting >1 joint. 2. Current use of allopathic colchicine within past 24 hours or homeopathic remedies within the past month. 3. Unstable medical or psychiatric condition (e.g., angina pectoris, myocardial infarction, heart failure, severe renal failure, renal transplant, cancer; psychosis, bipolar disorder; dementia). 4. Current use of anticoagulant drugs or herbs with anticoagulant properties. 5. Medical history of upper gastrointestinal diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Severity of pain in the effected area becomes lower. 2. The area of the affected joint become normal Safety and tolerability as determined by adverse event reporting, clinical laboratory results, vital signs, and physical examinations. Timepoint: 4(Four)Days | — |
Secondary
| Measure | Time frame |
|---|---|
| NATimepoint: NA | — |
Countries
India
Contacts
Public ContactDR. B.P. SRIVASTAVA
Outcome results
None listed