Randomized controlled clinical trial to evaluate the efficacy of Laghumanjisthadi Ghana and Raktamokshan in Vatarakta with special refence to Gout.
Overview
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Dr Pranoti Tukaram Khandekar
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- To Evaluate the efficacy Hypourecemic effect of Laghumanjisthadi Ghana and Raktamokshan in the management of Vatarakta.
Overview
Brief Summary
This is clinical trial Titled as ’ Randomized controlled clinical trial to evaluate the efficacy of Laghumanjisthadi ghana and Raktamokshan in Vatrakta with special reference to Gout.’
As it is controlled active trial there will be two groups included in the study .one with trial drug i,e Laghumanjisthadi Ghana and Raktamokshan another with standard drug i.e allopurinol .Aim of study is search for ayurvedic management of vatrakta i.e gout which is more economic , reliable ,effective and with less side effects.
this is comparative study between ayurveda management and standard drug practice of gout. Total sample size is 60 divided into these two group which will be 30 each group .After screening of patients in OPD and IPD level .
Patients with cardinal sign and symptoms of vatrakta as per ayurvedic classical texts as well as patients with serum uric acid level above 6 will be selected for trial. Written informed consent will be taken .
Laghumanjisthadi Ghana vati will be administered orally in 500 mg BD dose for 21 days along with Raktamokshan .It will be done by siravyadh method using scalp veinset .Additional sittings of Raktamokshan will be done as per neccesity. Tab Allopurinol will be given orally 100 mg OD for 21 days for Non ayurveda Arm .Before and After observation will be recorded in the Case Performa Paper .Follow up will be taken on 11 th and 21 st Day of trial .Patient can be withdrawn if any adverse effect seen or patient is no longer wanted to participate in trial.
Null Hypothesis
Laghumanjisthadi Ghana (500mg orally) twice a day for 21 days and Raktamokshan once is not significantly effective in Vatrakta with special reference to gout.
Alternate Hypothesis
Laghumanjisthadi Ghana (500 mg orally ) twice a day for 21 days and Raktamokshan once is significantly effective in Vatrakta with special reference to gout.
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Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Patients having clinical signs and symptoms of vatrakta with special reference to gout like Sandhi toda(jiont pricking pain),Sandhi daha(burning sensation),Sparshasahatva(Tenderness),Sandhi shotha (swelling),Raga (redness or discolouration of joint)described in aaaaaaaaayurvedic classics without any bar of caste ,sex,religion .
- •2 Patient having serum uric acid level above 6.
Exclusion Criteria
- •1 Patients having chronicity of vatrakta more than 5 years 2 Patients on Anti platelet aggregation drugs 3 Patients on anti coagulant drugs 4 Patients having bleeding disorders 5 Patients contraindicated for for Raktamokshana 6 Pregnant and Lactating mothers 7 Patients with illness like HIV, Malignancy,Cardiac disease ,Major Liver Disorders ,Uncontrolled Hypertension , End stage Renal disease.
Outcomes
Primary Outcomes
To Evaluate the efficacy Hypourecemic effect of Laghumanjisthadi Ghana and Raktamokshan in the management of Vatarakta.
Time Frame: 21 days
Secondary Outcomes
- 1 To evaluate the Hypourecemic effect of Laghumanjisthadi Ghana & Raktamokshan in Vatarakta.(2.To study adverse effect of Laghumanjisthadi Ghana if any)
Investigators
Dr Pranoti Tukaram Khandekar
Seth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya, Satara