SYNOPSIS

for the thesis on

“A controlled  Clinical  study  to  evaluate the efficacy of navkarshik kwath  IN cases of vatashonita w.s.r. to gouty arthritis”

PLAN OF STUDY

Selection of Cases-

• For the purpose of clinical trial, the patients of Vatashonita/ Gouty Arthritis will be selected randomly from O.P.D. & I.P.D. of State Ayurvedic College & Hospital, Lucknow, and the reffered cases which fulfill the criteria will also be included .
• A careful history, physical examination & necessary investigation will be performed as per proforma prepared for the present trial.

Inclusion criteria- 

1. Age: 21 – 60 years.
2. Sex: Both male & female.
3. Socioeconomic status: All
4. The patients of Vatashonita having serum uric acid  > 7 mg/dl in males and  >5.7 mg/dl in females and all 3 essential criteria with at least one non essential criteria .

Subjective criteria:

Essential Criteria-

1.     संधिषुरुक्  (pain in the affected joint)

2.     संधिषु श्वयथु (Swelling in the affected joint)

3.     स्पर्श असह्त्वं  (tenderness in affected area)

Nonessential Criteria-

1.     संधिषु राग  (redness in the affected joint)

संधिषु काठन्य (Stiffness / decreased / restricted movements of joint)

3.     संधिषु कण्डू (Itching in affected joint)

4.     संधिषु दाह  (Burning sensation over joint)

Objective criteria:

           Serum uric acid = >7 mg/dl in male  and  >5.7 mg/dl in female

Exclusion Criteria of the patient-

1.     Patients below 21 years and above 60 years of age.

2.     Complicated cases of gouty arthritis by others systemic disorders like uncontrolled Diabetes, Thyroid disorders and Psoriatic arthritis etc.

3.     Complicated cases of vatashonita by its updravas like Hikka, Moorchha, Moha, Visarpa, mansa-koth, angulivakrata, etc.

4.     Complicated cases of gout with chronic joint deformity, marked dysfunction, discharging tophi etc.

5.     Pregnancy and lactation.

6.     Patients with rheumatoid Arthritis, Osteo Arthritis, SLE, , Tuberculosis, Renal disease, Hepatic disease.

Criteria  for withdrawal-

1. Personal matters.         

2. Aggravation of complaints.

3. Inter current illness.  

4. Non willing patient.         

Type of study –Phase-2,Rational,  Randomized control group study.

Period of study - Total duration of clinical trial will be of 60 days

Follow up period- One month (without drug) after the treatment is completed.

Grouping of patients

Minimum 60 patients of  Vatashonita from OPD & IPD of SAC & H and referred cases from other hospitals will be selected and divided into two groups - 

1 Group A - In this group patients will be treated with Allopurinol 100 mg once in a day after breakfast with plane water .

2 Group B - In this group patients will be treated with Navkarshik kwath 100 ml / day in two divided doses .       

SAMPLE SIZE

Minimum 60 patients with approximately 10% dropouts.

Duration of treatment  =  60 days

Follow up during treatment = D15, D30, D45, D60.

Follow up after treatment = one month (without drug) after treatment is completed.

Diet adviced =

• Food which should be consumed –lots of water, buttermilk, skimmed milk, vegetable soups, whole wheat, shali rice, jau, moong dal, ginger, amla.
• Food which should be reduced in quantity – arhar dal, chana, cauliflower, spinach, brinjal, alcohol, strong tea & coffee, ghee & oil.
• Food to be avoided- fish, crab, oyster, lobster, organ meat, yeast, cheese, urad dal, kulthi, sem, chickoo, custard apple, sugarcane, peas, full cream milk, ice-cream, mushrooms.

Vihar adviced=

• All vaat vardhak vihar should be avoided ,As prolong hanging legs , prolong standing ,Restless body posture ,Long distance walking  e.t.c.

Criteria for Assessment

A.  Subjective  parameters-

All the signs & symptoms are graded 0, 1, 2, 3 or 0, +, ++,+++ (nil, mild, moderate & severe) on the basis of its intensity & severity given by patients on complained & confirmed by clinical examination before the trial drugs. The clinical improvement during and after trial drugs will also be correlated with previous intensity of the signs & symptoms.

1.     संधिषुरुक्  (Pain in affected joint) :

 This will be accessed by VAS analysis.

2.   (redness in the affected joint)

3.   संधिषु श्वयथु (Swelling in affected joint)

 à¤¸à¥à¤ªà¤°à¥à¤¶ असह्त्वं (tenderness in affected area)

5    संधि ( Range of movement of joints ): Determined by the diminish range of movement of knee joints.

6.   à¤¸à¤‚धिषु कण्डू (Itching in the affected joint)

B.   Objective Parameters –  Serum uric acid

The quantitative analysis of the values of the serum uric acid will be done before & after the treatment and during the follow up to compare the inflammatory condition of the affected joints.

Investigations-

• Blood– TLC , DLC , Hb% , ESR
• Urine- Routine (R), Microscopic (M)

• Serum Uric Acid
• R.A. Factor
• Liver Function Test- S. Bilirubin, SGOT, SGPT, S. Alkaline phosphatase
• Renal Function Test- Blood Urea, Serum Creatinine
• Blood Sugar -  Random
• X-ray of involved joint- AP view, Lateral view. (If required)
• Synovial Fluid Analysis. (If required)

Total effect of therapy

The total effect of therapy of this trail will be grouped as follows –

1.          Relieved

2.          Improved

3.          No response

4.          Worsen

1.     Relieved

                                                    i.     Patients have > or =75% relief in terms of symptoms

                                                  ii.      Normal range of pathological findings up to follow up period (serum uric acid level up to normal limit).

                                                iii.     No recurrence of disease up to follow up period.

2.     Improved

a.        Moderate improved

                                            I.             Patients having improvement between 51-74% in clinical symptoms.

                                          II.             Pathological findings are improved but not within normal limit.

                                                                    III.     No recurrence of disease up to follow up period.

b.        Mild improved   

                                            i.             Patients having improvement between 25-50% in clinical symptoms.

                                          ii.             Pathological findings are improved but not within normal limit

                                        iii.             No recurrence of disease up to follow up period

3. No response-

                                                    i.     Patients having improvement less than 25% in terms of clinical symptoms.

                                                  ii.     Pathological findings remain same as before trial.

                                                iii.     Disease may reoccur.

4.Worsened-

                                                    i.     Patients having no improvement in terms of clinical symptoms.

                                                  ii.     Pathological findings get disturbed (serum uric acid level may get increased).

                                                iii.     Disease may get worsened or symptoms may get increased.  

Observation

The observation of patients will be carried out during the trial at 15 days interval & after completion of trial of 60 days both by objective & subjective parameters taken. Result will be recorded as per case record form.