Study of Kaishore Guggulu and Balaguduchyadi Taila in the Management of Gout.
- Conditions
- Health Condition 1: null- GOUT (Vatarakta)Health Condition 2: M100- Idiopathic gout
- Registration Number
- CTRI/2018/04/013326
- Lead Sponsor
- CCRAS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Primary Gouty arthritis fulfilling the diagnostic criteria as recommended by the American College of Rheumatology (1977), it should meet the presence of any six of the following twelve criteria:
i. More than one attack of acute arthritis.
ii. Maximal inflammation developing within 1 day of onset.
iii. Monoarthritis attack
iv. Redness over affected joint
v. Unilateral attack on the first Metatarsophalangeal (Big Toe) joint.
vi. Unilateral attack involving Tarsal joint.
vii. First Metatarsophalangeal (Big Toe) joint Painful or Swollen.
viii. Suspected Tophi
ix. Hyperuricemia (equal or more than 7.0 mg/dl)
x. Asymmetrical swelling within joint (X Ray)
xi. Sub cortical cysts without erosion (X Ray)
xii. Negative culture from joint fluid during attack.
Though mentioned as one of the criteria, no synovial fluid examination will be carried out. Diagnosis will be made out of eleven ACR criteria
2. Willing and able to participate in the study for 14 weeks.
1. Age less than 18 yrs or more than 65yrs.
2. History of any trauma/ fractured joint/ surgical/diagnostic intervention with reference to the affected joint(s).
3. Patients with co-morbidities such as Rheumatoid arthritis, Psoriatic arthritis etc.
4. Patients with poorly controlled Hypertension (equal or more than 160/100 mm of Hg).
5. Patients with poorly controlled Diabetes Mellitus (HbA1c equal or more than 8.0%)
6. Patients with evidence of malignancy.
7. Patients with unstable cardio-vascular disease.
8. Patients with hypothyroidism having TSH level more than 10mlU/lit and known cases of hyperthyroidism.
9. Patients with any concurrent hepatic disorder (defined as liver enzymes SGOT/SGPT more than 2 times of upper normal limit) or Renal Disorders (defined as S.Creatinine more than 1.4mg/dl) or Severe COPD.
10. Alcoholics/drug abusers.
11. H/o hypersensitivity to any of the trial drugs or their ingredients.
12. Pregnant/lactating woman.
13. Any other condition which the Principal Investigator thinks may jeopardize the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1 Reduction in Serum Uric Acid levels. <br/ ><br>Timepoint: 1 Time frame- From base line to end of treatment period) <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1 SF 36 <br/ ><br>2 Any change in Visual Analogue Scale (VAS) Score for pain. <br/ ><br>3 Patientâ??s Global Assessment <br/ ><br>4 Physicianâ??s global Assessment <br/ ><br>Timepoint: 1 At the baseline and at the end of 12th week (at end of treatment period) <br/ ><br>2 From base line to end of 4th, 8th, 12th week and at the end of follow up(without drug)of 2 week. <br/ ><br>3 From base line to end of 4th, 8th, 12th week and at the end of follow up(without drug)of 2 week. <br/ ><br>4 From base line to end of 4th, 8th, 12th week and at the end of follow up(without drug)of 2 week.