Efficacy of Amrita Guggulu and Pinda Taila in the Management of GOUT.

Phase 3

Active, not recruiting

• Conditions: Clinical trial will be conducted on Gout Patients fulfilling the Inclusion criteria

• Registration Number: CTRI/2014/08/004929
• Lead Sponsor: Central Council for Research in Ayurvedic Sciences CCRAS

Brief Summary

Vatarakta is major disorder of Vata & Rakta. Acharya Caraka has classified in two types- 1. Uttana, 2. Gambhira. Signs and symptoms of Utthana Vatarakta are Kandu, daaha, rujaa, toda, sphurana and darkening of skin. The signs and symptoms of Gambhira Vatarakta are Shotha (inflammation), kaathinya, vedanaadhikya, daaha, toda, bheda, sphurana, paaka and joint deformity in later stage. When all the symptoms and signs of both the types are present it is called as Ubhayagat Vatarakta. Acharya Sushruta considers these as stages of Vatarakta instead of types.

On the basis of the symptomatology, Vatarakta can be correlated with the desease condition Gout. Gout is a rheumatic disease resulting from deposition of uric acid crystals (monosodium urate) in tissues and fluids within the body. This process is caused by an overproduction or under excretion of uric acid.

The drugs Amritadi Guggulu and Pinda Taila are among various drugs mentioned in ayurveda that help to treat Vatarakta. This study is aimed to establish their role in treating gout and establish their safety by assessing modern parameters.

The contents of these drugs are:

Amritadi Guggulu consists:

1.Guggulu (Resin of Commiphora mukul),

2.Triphala (fruit pilp of Terminalia chebula Retz, Terminalia bellirica, Emblica officinalis),

3.Guduchi (Stem of Tinospora cordifolia)

4.Danti (Root of Baliospermum montanum)

5.Trikatu ( Fruit of Piper longum, Piper nigrum, Zingiber officinale)

6.Vidanga ( Fruit of Embelia ribes)

7.Tvak (Stem bark of Cinnamomum zeylanicum)

8.Trivrit (Root of Operculina turpethum)

Pinda Taila consists:

1.Mdhuchhishta (Beewax),

2.Manjistha, (Root of Sida cordifolia)

3.Sarjarasa (Resin of Shorea fobusta Gaertn. f.)

4.Sariva (Root of Hemidesmus indicus).

5.Til taila (Sesmum oil)

The objective of the trial is to validate and establish the clinical efficacy of these classical ayurvedic formulations on scientific basis to establish its safety in the treated subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-11
• Last Update Posted: 2014-08-26

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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: i.More than one attack of acute arthritis.
• ii.Maximal Inflammation developing within 1 day of onset.
• iii.Monoarthritis attack.
• iv.Redness over effected 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 (more than 7.0 mg per dl) x.Asymmetrical swelling within joint (X Ray).
• xi.Sub cortical cysts without erosions (X Ray).
• xii.Negative culture from joint fluid during attack.
• 3.Willing and able to participate in the study for 14 weeks.

Exclusion Criteria

• i.History of any trauma or fractured joint or surgical or diagnostic intervention with reference to the affected joint (s).
• ii.Patients with comorbidities such as Rheumatoid arthritis Psoriatic arthritis etc.
• iii.Patients with poorly controlled Hypertension (> 160/100 mm of Hg).
• iv.Patients with poorly controlled Diabetes Mellitus (HbA 1c more than 8.0 percent) v.Patients with evidence of malignancy.
• vi.Patients with unstable cardiovascular disease.
• vii.Known cases of Hypothyroidism or hyperthyroidism.
• viii.Patients with any concurrent hepatic disorder (defined as liver enzymes SGOT or SGPT more than 2 times upper normal limit) or Renal Disorders (defined as S.
• Creatinine more than 1.4 mg per dl) or Severe COPD.
• ix.Alcoholics/drug abusers.
• x.History of hypersensitivity to any of the trial drugs or their ingredients.
• xi.Pregnant or lactating woman.
• xii.Any other condition which the Investigator thinks may jeopardize the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean percentage decrease in Serum Uric Acid levels from the base line to the end of study period.	12 weeks regimen and followup for 2 weeks

Secondary Outcome Measures

Name	Time	Method
Improvement in SF-36 Health Survey score, Patients Global Assessment, Physicians global Assessment, pain VAS scale.	To assess the safety of the trial drug by lab parameters and observing any occurrence of any ADR or AE.

Trial Locations

Locations (2)

ARRI Jammu; 🇮🇳 JAMMU, & KASHMIR, India

NIAPR Patiala; 🇮🇳 Patiala, PUNJAB, India

ARRI Jammu

🇮🇳JAMMU, & KASHMIR, India

Dr Laxaman Bhurke

Principal investigator

01912546475

dewa2007@rediffmail.com