A Randomized Open-labelled controlled clinical study to evaluate the efficacy of Balashatavaryadi Ksheerapaka in the management of Vatarakta with special reference to Gouty arthritis
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Significant reduction in serum uric acid level and symptomatic relief
Study Overview
Brief Summary
Vatarakta is one of the painful joint disorders mentioned by Acharya Charak. It is caused by the vitiation of Vata Dosha and Rakta Dhatu.
Vatarakta resembles the symptomatology of gout which is caused by hyperuricemia.
Hyperuricaemia is defined as a serum or plasma urate concentration greater than 7 mg/dL in males and 6 mg/dL in females. Gout is an inflammatory response to the monosodium urate monohydrate (MSUM) crystals formed secondary to hyperuricaemia. (1)
The incidence of gout varies in population from 0.2 to 3.5 per 1000, with an overall prevalence of 2-26 per 1000. (1)
The clinical progression of gout can lead to gouty arthritis, characterized by painful swelling and tenderness, usually of the great toe and metatarsophalangeal joint. (2)
M10.00 is the ICD-10-CM code used for diagnosing Gouty arthritis. (3) ED-08 is the National Ayurveda morbidity code (NAMC) for Vatarakta. (4)
In contemporary medicine, treatment for gouty arthritis includes non-steroidal anti-inflammatory drugs (NSAID), Colchicine, Allopurinol, Febuxostat and steroids. These drugs may cause adverse reactions like Dyspepsia, hypersensitivity, headache, nausea and so on. Long-term use of NSAID is not recommended due to the risk of toxicity (5)
Thus, there is a need for an effective drug that will manage Gouty arthritis and prevent related co-morbidities.
Balashatavaryadi Ksheerapaka has Tikta Madhura predominant Rasa and Madhura Vipaka which might help in Vata-Pitta Shamana and reducing Shoola. Sheeta Virya of the formulation might help in Dahaprashamana. Majority of the drugs are Shoolahara and Shothahara, which is a predominant clinical symptom of Vatarakta. This formulation contains drugs having anti-inflammatory and analgesic properties. (6) Hence, Balashatavaryadi Ksheerapaka is taken as a trial drug to evaluate its therapeutic efficacy in Vatarakta
Amritaadi Kwath is a proven drug for the management of Vatarakta. It is Tridoshashamak, Dahaprashamak and has anti-inflammatory properties. Hence it is taken as a control drug to compare and establish its efficacy
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 21.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Subjects fulfilling 6 out of 12 criteria of the American College of Rheumatology.
- •Subjects willing to participate with written informed consent.
Exclusion Criteria
- •• Subjects with Serum uric acid levels more than 12 mg/dl in both the genders • Subjects diagnosed with other joint diseases • Subjects with a history of trauma, fractured joint, surgical or diagnostic intervention with reference to affected joint(s) in the past 1 year.
- •• Subjects who are pregnant and lactating mothers.
- •• Subjects with any uncontrolled systemic illness including Diabetes mellitus, Hypertension and chronic kidney disease.
- •• Any other conditions interfering the course of treatment.
Outcomes
Primary Outcomes
Significant reduction in serum uric acid level and symptomatic relief
Time Frame: 0,15,30, 45 DAY
Secondary Outcomes
- Generation of in depth analyzed data on the(different aspect of disease)
Investigators
Dr Angolkar Rachana Satish
Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore