Efficacy of Habb-e-Chobchini (Oral administration) and Dimad Muhallil (topical application) in Niqris (Gout)(NUMC: L-7; ICD: M10): A randomised single blind double dummy placebo controlled clinical trial

The clinical trial aims to evaluate the efficacy and safety of Habb-e-Chobchini taken orally and Dimad Muhallil applied topically for the treatment of Niqris or Gout. It is a randomized double blind double dummy placebo controlled study conducted at the Regional Research Institute of Unani Medicine Chennai. A total of 87 participants aged between 18 and 65 years with serum uric acid levels from 7 to 9.5 mg per dl will be enrolled. Patients with serious illnesses pregnancy recent surgery or known allergies to the trial drugs are excluded. The study duration is two years with treatment lasting eight weeks. Participants are divided into three groups. Group A receives Habb-e-Chobchini and placebo Dimad. Group B receives placebo oral and Dimad Muhallil. Group C receives both active Habb-e-Chobchini and Dimad Muhallil. Habb-e-Chobchini will be given as 500 mg twice daily and Dimad Muhallil as 10 grams twice daily. Clinical and laboratory follow ups will be on day 14 28 42 and 56. Safety will be monitored by blood tests including hemoglobin total leukocyte count ESR liver and kidney function tests and urine examination. Efficacy is assessed by reduction in serum uric acid CRP ESR and improvements in quality of life visual analogue scale and verbal rating scale. Data will be analyzed by paired t tests with significance at p less than 0.05. Withdrawal is allowed for adverse events non compliance or patient request. The trial also assesses the Unani concept of Mizaj temperament and ensures drug accountability. Informed consent will be obtained after explaining study procedures and risks. The primary goal is reduction of serum uric acid and the secondary goal is improving symptoms and quality of life.