To assess the effect of Ayurvedic medicines on gout

Phase 2/3

Not yet recruiting

• Conditions: Primary osteoarthritis of other joints. Ayurveda Condition: Vataraktam,

• Registration Number: CTRI/2021/09/036364
• Lead Sponsor: Central Council for Research in Ayurvedic Sciences CCRAS

Brief Summary

*Vatarakta* is the major example of *vata vyadhi*, caused due to *Avarana* pathology. It is a disease which is associated with an inheretent abnormality of purine metabolism resulting in over production of uric acid. It is characterized by acute attack pain and swelling of one or more joints. In untreated cases uric acid in the form of monosodium urate gets deposited in the cartilage of joints and later on it causes deformities. The literature enlists a number of *Guggulu prayogas* in the management of *vatarakta*. An additional cavernous revise was indispensable to bring out the precise outcome of these products.Keeping these visions in mind, the particular comparative study was performed with *Gokshuradi Guggulu* and *Nimbadi Churna* which are explained in the same context, Aim and object of this study is to evaluate their therapeutic efficacy in the patients of *Vatarakta* ( Gout) along with safety measures by observing adverse events ( AE) if any or Adverse drug reaction ( ADR). The efficacy of these drugs would be assessed by observing the improvement in Subjective parameters ( Clinical symptoms), mean percentage decrease in serum uric acid levels, improvement in SF-36 Health survey score, patients global assessment, physicians global assessment, pain VAS scale and lab parameters.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-09-09
• Study Start: 2021-09-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

• Patients of either sex aged between 25 and 65 years Confirmed cases of 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: More than one attack of acute arthritis.
• Maximal Inflammation developing within 1 day of onset.
• Monoarthritis attack Redness over affected joint Unilateral attack on the first Metatarsophalangeal (Big Toe) joint.
• Unilateral attack involving Tarsal joint.
• First Metatarsophalangeal (Big Toe) joint Painful or Swollen.
• Suspected Tophi Hyperuricemia (≥7.0 mg/dl) Asymmetrical swelling within joint (X Ray) Sub cortical cysts without erosions(X Ray) Negative culture from joint fluid during attack.
• Willing and able to participate in the study for 14 weeks.

Exclusion Criteria

• Age less than 25 yrs or more than 65yrs.
• History of any trauma/ fractured joint/ surgical/diagnostic intervention with reference to the affected joint(s).
• Patients with co-morbidities such as Rheumatoid arthritis, Psoriatic arthritis etc.
• Patients with poorly controlled Hypertension (>160/100 mm of Hg).
• Patients with poorly controlled Diabetes Mellitus (HbA1c > 8.0%) vi.
• Patients with evidence of malignancy.
• Patients with unstable cardio-vascular disease.
• Known cases of Hypothyroidism or hyperthyroidism.
• ix.Patients with any concurrent hepatic disorder or Renal Disorders (S.
• Creatinine >1.2 mg/dl) or Severe COPD.
• x.Alcoholics/drug abusers.
• xii.Pregnant/lactating woman.
• xiii.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
Change in Pain assessment on VAS scale	3 months
Change in Ayurvedic parameters of Vatarakta	3 months

Secondary Outcome Measures

Name	Time	Method
Mean percentage decrease in Serum Uric Acid levels from the baseline to the end of study period.	Improvement in SF-36 Health Survey score

Trial Locations

Locations (2)

Central Ayurveda Research Institute; 🇮🇳 Kolkata, WEST BENGAL, India

Regional Ayurveda Research Institute; 🇮🇳 Gwalior, MADHYA PRADESH, India

Central Ayurveda Research Institute

🇮🇳Kolkata, WEST BENGAL, India

Dr Dipsundar Sahu

Principal investigator

8895173999

drdssahu@gmail.com