A Randomized clinical study to evaluate the efficacy of sirvyadha with or without jatamayadi lepa in vata - rakta w.s.r to gout
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- 1)reduction in the range of serum uric acid will be assessed.
Study Overview
Brief Summary
Vatarakta is a metabolic disorder and a grievous medical condition. It is one among Vatavyadi caused due to avarana (occlusion). As the name suggest it is due to the vitiation of Vata Dosha and Rakta Dhatu (blood). Vatarakta is classified in to - Uttana Vatarakta and Gambhira Vatarakta on the basis of dhatu involvement, symptoms of uthana vatarakta are Kandu, Daha, Ruja, Ayama, Toda, Spurana, Kunchana, Raga, Bheda, Gourava and Suptata.
Gout is a common type of arthritis; the symptomatology of this has striking similarities with those explained in Vatarakta
This is due to excess accumulation of uric acid in the blood stream which forms crystals in the joint that causes intense pain, swelling and stiffness in phalanges, it usually affects the joint of the big toe and is marked by transient painful attacks of acute arthritis initiated by crystallization of urates,eventually it leads to chronic gouty arthritis and the deposition of masses of Monosodium Urate (MSU) crystals in joints and other sites, creating tophi. The essential biochemical requirement for the development of clinical gout is hyperuricemia. The management of Vatarakta aims at Vata Hara and Rakta Prasadaka measures. In this respect the Shodhana chikitsa like Raktamokshana (Siravyadha) is advised as primary treatment by Acharya, Raktamokshana (Siravyadha) is a unique subset of accredited drugless surgical technique in Ayurveda; often ignored, misunderstood in the mainstream practice. It is indicated primarily in generalized vitiation of blood, causing distress. Siravyadha treatment relieves the symptoms early, modifies the underlying pathology and also reduces the duration of treatment. it can bring down the oral medicine burden to the patient which has to be taken for years together.
In sahasrayoga, thaila prakarana, kalka dravya of balaguluchyadi taila i.e., Jadamayadhi churna which ingredients are sheeta veerya can reduces raga, shopha, daha and shola caused due to vata rakta.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 20.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •a.Subject with hyperuricemia and presenting with lakshanas of Vatarakta.
- •b.Chronicity less than 5 years, c.Not associated with complete joint destruction.
- •d.Uric acid above 7 mg/dl.
Exclusion Criteria
- •Subject with major illness like hepatitis, AIDS, malignancy and RA factor positive.
- •Subject with uncontrolled diabetes mellitus and hypertension, Koch’s arthritis, Septic arthritis, Chronic renal failure, Severe Systemic multi organ syndromes and uric acid cristal stones.
- •Subjects on opioids, anticoagulant drugs.
- •Classical contraindications for siravyadha procedure.
Outcomes
Primary Outcomes
1)reduction in the range of serum uric acid will be assessed.
Time Frame: Base line - serum uric acid will be assessed and 1 st sitting of Siravyadha | 1 st follow up after 7days and second sitting of siravyadha serum uric acid will be assessed | 2 nd follow up 21 days after baseline and 3 rd sitting of siravyadha , serum uric acid will be assessed | 3rd followup after 28 days of baseline and 4th sitting of siravyadha , serum uric acid will be assessed
Secondary Outcomes
- 1)reduction in the range of serum uric acid(2) symptomatic changes like pain , burining sensation , swelling & discoloration after inntervention)
Investigators
Dr Sambu Surendran
HASS Ayurveda Mahavidhyalaya Hubballi.