“A STUDY OF SANTARPANIYA ADHYAYA OF CHARAKA SAMHITA IN CONTEXT TO PRINCIPLE OF MANAGEMENT FOR SANTARPAN NIMITTAJA VYADHIâ€

This study is open label clinical study to evaluate the effect of Musta Aargavadhadi kasaya on sthaulya. Routine blood investigation will be performed to rule out other systematic pathology. Special scoring scale has been prepared based on information in Ayurvedic classical texts which will be utilized for assessment and evaluation PLAN OF STUDY:

Materials & Methods: Clinicalmaterial would be the patients, drug and research plan. Clinical study will bestarted only after getting clearance from institutional ethics committee.

SELECTION OF THE PATIENTS:

Inclusion Criteria:

1. Patients between the age group of 20 years to 50 years and having classical signs and symptoms of Sthaulya i.e. Chala Sphik Udara Stana, Angagandha, Swedadhikya, Kshudhadhikya, Pipasadhikya , Kshudra Shwasa , Nidradhikya will be selected, irrespective of sex, religion etc. from the O.P.D. and I.P.D. of I.P.G.T and R.A. Hospital, G.A.U. Jamnagar.
2. Detailed clinical history will be taken on specially prepared research proforma and filled in the record of B.T. and A.T. data for the statistical study.
3. B.M.I. - 25 Kg/m2  to 35 Kg/m2

Exclusion Criteria:

1.      Ageof patient less than 20 years and more than 50 years.

2.     Patients having major illnesslike cardiac diseases, diabetes mellitus etc & also the involvement ofother systemic disorders.

3.     Patients having Sthaulya due togenetics, pregnancy, drug induced, cushing’s syndrome, hypothyroidism, otherhormonal disorder and related to any disease

Investigations:

Investigations willbe done before treatment to rule out any other associated pathology. Onlyimportant investigations related to the study will be repeated after treatmentif needed.

1. Blood: Complete blood count and Heamogram
2. Biochemical examination**:** FBS, Sr. Cholesterol, Sr. Triglyceroides, HDL, LDL, VLDL.
3. Thyroid function test: T3, T4, TSH- When and where required.

Objective Criteria:

                                                                                                                                                                                                                  It will be mainly assessed on the basis of Body weight , BMI and body fatpercentage before starting the treatment and after completion of the treatmentin terms of percentage relief and statistical evaluations.

For the present study the girth measurementsof certain regions using measuring tape before and after the treatment willalso be carried out. The girth measurement of following areas where will betaken into consideration.

1. Neck            -          At the level of Thyroidcartilage.

2. Chest           -           In normal expansion at the level ofnipple.

3. Abdomen    -           At the level of umbilicus.

4. Hip              -           At the level of highest point ofdistention of buttock

5. Mid arm      -           Mid of the arm between shoulderjoint and elbow joint.

6. Mid thigh    -          Mid of the thigh betweenpelvic and elbow joint.

In case of girth measurements, the meanvalues of both sides will be taken before and after treatment.

The effectiveness of therapy on body fat willbe assessed by measuring the skin fold thickness by Vernier calipers before andafter the treatment in some particular areas like,

1. Skin fold thickness of the middle portionof the Biceps muscle.

2. Skin fold thickness of the middle portionof the Triceps muscle.

3. Skin fold thickness of the inferiorportion of the scapula.

4. Skin fold thickness of the abdomen.

The skin fold measurement will be carried outbilaterally after exposing the skin properly in the above mentioned region. Thesuperficial skin along with subcutaneous fat but except muscles a clinch willbe made and the proportionate, which is stretched as skin fold will be measuredby placing it between two points of Vernier Calipers. For all the regions, themean values of both sides of the body before and after the treatment will berecorded.

Grouping:

Patientswill be randomly divided into below mentioned 2 groups:

 Group **A:**Musta Aragvadhadi Kashaya(Ca. Su. 23/12)

 Group B:  Placebo Capsule.

Patients of both the groups will besuggested similar type of Vyayama and Pathyapathya

Dose & Posology :Group A

Matra (dose) : 2 pala-100ml

Kala  : Nirann pratah evum sayam Kale

Anupana : Sukhosna jal (Lukewarm water)

Duration:   60 days

Preparationof kwath :

Kwath of above mentioned drugs willbe prepared by classical Ayurvedic method. Mixed rough powder of Kwathdravyawill be boiled with quality sufficient water up to the evaporation of ¾ parts.Remaining part (1/4 ) with filtered and  will be used as medicine.

Group B: PlaceboCap.(Rosted sauji) :

Dose–2 Capsules of 500 mg.

Kala-  Before meals two times.

Anupana- Sukhosna jal( Luke warm water )

Criteria for assessment:

1.      Aspecial scoring pattern will be developed for assessing improvement in signsand symptoms before and after treatment.

2.     Laboratory investigationsconducted before and after treatment will also be considered as assessmentcriteria.

3.     Assessment of BMI, body fatpercentage, reduction in weight and girth measurements.

Theobtained data will be analyzed statistically and presented along withexplanatory notes, discussion and conclusion.