Analytical clinical study of Godugdha Vatarana basti in different stages of Gridhrasi

MATERIAL AND METHODS:

All the classical texts will be well churned to establish the facts about VaitaranaBasti and its application in Gridhrasi. This is a single blind clinical trial. The main object of the present work is to undertake a clinical study of Vaitarana Basti in the management of Gridhrasi.

Selection of the Cases

For this clinical study, patient of age group 20 year to 60 years will be randomly selected for the study. The cases will be registered on the clinical basis and investigation from OPD and IPD of Himalayiya Ayurvedic (P.G.) Medical College and Hospital, Dehradun, U.K. Cases will be selected randomly for this clinical study irrespective of Religion, Occupation, Sex etc.

INCLUSION CRITERIA

Criteria for diagnosis will be done on the basis of sign and symptoms available in the Ayurvedic and Modern texts as well as with the help of following parameters.

·       Patient fit for Vaitaranabasti

·       Presence of Ruk, Toda, Stambha and Spandana in the Sphik, Kati, Uru, Janu,Jangha and Pada.

·       Tenderness along the course of sciatic nerve

·       Patients between age group of 20 to 60 years were including.

Exclusion Criteria

·       Patient unfit for vaitaranabasti

·       Tumour of cauda equina and lumbosacral plexus

·       Uncontrolled Diabetes mellitus

·       Cardiovascular disease

·       Pregnanant and lactating mother

·       Tuberculosis of Vertebral column

Diagnostic criteria

·       Rukh (Pain)

·       Toda (Pricking)

·       Stambha (Stiffness) and

·       Spandana (Ttiching) in the ( Sphik, Kati, Uru, Janu, Jangha and Pada)

·       Gaurava (Heaviness)

·        S.L.R. test

·       Popliteal compression test

·       Knee-jerks and ankle-jerks.

Investigation

·       CBS, ESR

·       RBS

·       Lipid Profile

·       LFT

·       KFT

·       Routine and microscopic examination of urine and stool

·       X-ray of Lumbosacral region (Anterio Posterior & Lateral view)

AssessmentCriteria

The improvement in the patients will be assessed mainly on the basis of relief in the cardinal symptoms of the disease. To assess the effect of therapy objectively, all the sign and symptoms will be given scoring pattern dependingupon their severity as below:

Rukh (Pain)

·       No pain - 0

·       Occasional pain - 1

·       Mild pain but no difficulty inwalking- 2

·       Moderate pain and slightdifficulty in walking- 3

·       Severe pain with severe difficultyin walking- 4

Toda (Pricking Sensation)

·       No pricking sensation - 0

·       Occasionally pricking sensation - 1

·       Mild pricking sensation - 2

·       Moderate pricking sensation - 3

·       Severe pricking sensation - 4

Stambha (Stiffness)

·       No stiffness - 0

·       Sometimes for 5 – 10 minutes - 1

·       Daily for 10 – 30 minutes – 2

·       Daily for 30 – 60 minutes - 3

·       Daily more than 1 hour - 4

Spandana (Twitching)

·       No Twitching - 0

·       Sometimes for 5-10 minutes - 1

·       Daily for 10-30 minutes - 2

·       Daily for 30-60 minutes - 3

·       Daily more than 1 hour - 4

Gaurava (Heaviness)

·       No heaviness - 0

·       Mild heaviness - 1

·       Moderate heaviness - 2

·       Severe heaviness - 3

S.L.R. Test

·       More than 90° - 0

·       71° – 90° - 1

·       51° – 70° - 2

·       31° – 50° - 3

·       Up to 30° - 4

Other symptoms

·       Symptom present – 2

·       Markedly reduced - 1

·       Absent - 0

·       No remarkable improvement - 2

STATISTICAL ANALYSIS

CRITERIA FOR ASSESSING THE TOTAL EFFECT

Considering the overall improvement will be shown by the patient in sign and symptoms, the total effect of thetherapywill have been assessed as below.

1. Complete remission: - > 75% relief in signs and symptoms

2. Marked Improvement: - 51% to 75% relief in signs and symptoms

3. Moderate Improvement: - 25 to 50% relief in signs and symptoms

4. Unchanged: - Below 25% relief in signs and symptoms

Sample Size

As per sample size calculated: Formula,

n =

Z2 P (1-P)

|d2

Where, P = Prevalence rate of Amavata which is 0.75%

d = Margin of error generally taken is 0.05%

Z = Z Score = 1.96

By above calculation, n = 288.12

Due to limitation of time and other resources, we will take 50 patients for the present study which will be randomly selected for a group.

Method of Data Collection:

After the completion of treatment, the assessment will be done on same criteria as before the treatment and scoring will be done on the same pattern. The different tables of scores, obtained before treatment and after treatment, will be prepared for the comparison and statistical analysis will be done.

Type of Study:Randomized Clinical Trial

**Level of Study:**OPD and IPD Level

Period of Study: 1 1/2 Months

**Duration of Treatment:**15 days

·       There will be 2 sittings.

·       8 days Basti and 8 days’ Rest.

Method of Treatment:

The patients will be randomly divided into two groups.

·       VaitaranaBasti with Godugdha(Treatment Group): The patients of this group will be given VaitaranaBasti in the format of KaalBasti for four weeks.

Method of Intervention:

Intervention Name

Group A

|Selected Drugs

ForSnehana – TilTaila

|For Swedana – NadiSweda with DashmoolaKwath

|SaindhavaLavana (Rock Salt)

|TilaTaila (Sesame Oil)

|Guda(Jaggery)

|Godugdha (Milk of Cow)

|Chincha (Amlika)

|Form of Medicine

Vaitaranabasti

|Composition of Medicine

All the components of VaitaranaBasti

|Preparation of Medicine

According to the method mentioned in the book

|Dose of Medicine

380ml

|Route of Administration

Rectal Route

|Procedure

Basti

|Duration

15 days

|Sittings

1 Sittings

(15 days Basticountinous)

 Follow Up:

·       Follow up – After 15th day of treatment

7. OBSERVATION AND RESULT:

Observation

Observation will be done on the basis of Subjective and objective parameters before and after completion of the treatment.

Statistical Analysis

To obtain the efficacy of the therapy, proper statistical analysis will be carried out of available data.Mean, percentage, ±S.D., ±S.E., ‘t’ and P value were calculated. Paired ‘t’ test will be used for calculating the ‘t’value.

Result: The result will be analysed statistically and discussed.